La Terapia a Pressione Negativa (TPN)

2012
HTA Territoriale
Evidence Report N°1
Novembre 2012
Report N. 1 – HTA Assistenza Territoriale
La Terapia a Pressione Negativa (TPN)
INDICE
INTRODUZIONE ALLA TPN

Caratteristiche generali della Terapia a
Pressione Negativa (TPN)

Pag 4
L‟impatto delle lesioni cutanee in
sanità
Pag 8
METODOLOGIA DI LAVORO PER LA REALIZZAZIONE
DELL’EVIDENCE REPORT

Il gruppo regionale sull‟HTA distrettuale e
l‟evidence report sulla TPN

Pag 11
L‟analisi della letteratura scientifica Pag 14
RISULTATI

Evidenze
dalla
letteratura
secondaria
(report HTA, review, metanalisi, evidence
based
reccomandations)
2002-2012

nel
periodo
Pag 19
Evidenze dalla letteratura primaria (trial clinici,
Report N. 1 – HTA Assistenza Territoriale
studi descrittivi e costo-efficacia) nel biennio
2
2011-2012
Pag 24
Considerazioni generali
Pag 26
Conclusioni
Pag 33
Tabelle sinottiche
Pag 35
Bibliografia generale
Pag 69
Report N. 1 – HTA Assistenza Territoriale
La Terapia a Pressione Negativa (TPN)
3
La Terapia a Pressione Negativa (TPN)
CARATTERISTICHE GENERALI DELLA TERAPIA A PRESSIONE
NEGATIVA (TPN)
La
Terapia
a
Pressione
Negativa
(TPN)
rappresenta una tecnica terapeutica per il trattamento
di un‟ampia gamma di lesioni cutanee acute1 e
croniche2.
Le modalità attraverso le quali l‟applicazione
della TPN favorisce il processo curativo sono:

retrazione della ferita;

stimolazione della formazione del tessuto di
granulazione;

pulizia continua della ferita dopo sbrigliamento
chirurgico;

rimozione
continua
di
fluido
interstiziale
(essudato);

riduzione dell‟edema interstiziale;

aumento dell‟irrorazione sanguigna locale;

riduzione della carica batterica;

riavvicinamento dei margini della ferita.
Il trattamento con TPN si realizza mediante l‟utilizzo di
dispositivi che consentono un‟applicazione controllata e
Report N. 1 – HTA Assistenza Territoriale
localizzata
una
pressione
sub-atmosferica
in
corrispondenza del sito della ferita.
Il sistema che permette di realizzare tale modalità è
in genere costituito da tre componenti principali:
1
1.
apparecchiatura;
2.
kit di medicazione;
3.
tubo.
Lesioni che hanno una durata inferiore o uguale a 8 settimane
Lesioni che, dopo 8 settimane hanno perso la capacità di ricostituire la
propria integrità anatomica e funzionale. Tali lesioni richiedono un tempo
prolungato
per
cicatrizzare/guarire,
non
guariscono/cicatrizzano
completamente o si riformano frequentemente
2
4
di
La Terapia a Pressione Negativa (TPN)
L‟apparecchiatura, di dimensioni, forme e materiali
variabili
a seconda del produttore, generalmente
contiene:
•
un modulo di interfaccia e di controllo per
operazioni di “input/output” dei dati, in genere
costituito da un display per la visualizzazione
delle operazioni da effettuare, dei parametri
impostati e del valore dei parametri erogati
(tipicamente il valore della pressione espresso
in mm Hg) e da tasti per la selezione delle
funzioni;
•
una pompa che genera pressioni negative,
impostabili a diversi valori;
•
un contenitore per la raccolta dell‟essudato
(canister), comprensivo di filtri.
La medicazione (schiuma o garza) è di dimensioni e
forme variabili in funzione della ferita da trattare. La
schiuma utilizzata generalmente è ricoperta da un film
trasparente, utile ad isolare e sigillare il letto della ferita
dai batteri, e a creare il vuoto. Diversi fabbricanti
producono schiume contenenti argento o antibiotici. Le
garze non-aderenti sono posizionate vicino al letto della
Report N. 1 – HTA Assistenza Territoriale
lesione
e
la
garza
inumidita
viene
utilizzata
per
tamponare completamente la ferita. Possono essere
anche
utilizzate
applicata,
la
garze
garza
antimicrobiche.
viene
ricoperta
Una
da
un
volta
film
trasparente adesivo, che anche in questo caso “sigilla”
l‟area della lesione.
Il tubo, generalmente in polietilene o in silicone,
presenta la parte distale inserita direttamente nella
medicazione permettendo così di veicolare, grazie al
vuoto creato dalla pompa, l‟eccesso dì essudato nel
canister dell‟apparecchiatura. Questo contenitore è
5
collegato alla pompa del vuoto che fornisce pressione
La Terapia a Pressione Negativa (TPN)
negativa, continua e intermittente, regolata a seconda
della lesione. La pressione negativa è applicata in un
range di 50-200 mmHg in modalità intermittente
o
continua.
I dispositivi possono essere sia fissi che portatili,
consentendo
di
erogare
la
terapia
a
pazienti
ospedalizzati o domiciliari. Attualmente esistono diversi
dispositivi per la TPN. Pur condividendo il meccanismo di
base, i vari dispositivi si differenziano principalmente in
base al tipo di medicazione utilizzata.
sembrerebbero
influenzare
le
Tali differenze
indicazioni
e
le
controindicazioni all‟utilizzo sulla base di quanto riportato
a riguardo dalle varie ditte produttrici (figure 1,2)
Figura1. Indicazioni all‟utilizzo della TPN riportate dalle ditte produttrici
Indicazioni all'uso in
almeno 8 dispositivi su 9
Report N. 1 – HTA Assistenza Territoriale
•Traumi acuti
•Lesioni da pressione
•Ulcere arti inferiori
•Ulcere diabetiche
•Ferite deiscenti
6
Indicazioni all'uso
itra 3 e 5 dispositivi
su 9
•Ustioni
•Trapianti di cute
•Lembi
•Ferite subacute
•Ulcere
neuropatiche
Indicazioni all'uso
in meno di 2
dispositivi su 9
•Addome aperto
dopo laparotomia
•Fistole esplorate
La Terapia a Pressione Negativa (TPN)
Figura 2. Controindicazioni all‟utilizzo della TPN riportate dalle ditte
produttrici
Controindicazioni all'uso in 9
dispositivi su 9
•Osteomielite non trattate
•Presenza di escara
•Lesioni maligne
•Esposizione di organi vitali
Controindicazioni
all'uso in 5 dispositivi su
9
•Fistole non enteriche
e non esplorate
•Siti anastomotici
esposti
Controindicazioni
all'uso in meno di 2
dispositivi su 9
Report N. 1 – HTA Assistenza Territoriale
•Disordini della
coagulazione
•Malattie
ematologiche
•Fistole non esplorate
•Malnutrizione
•Pleura esposta
•Peritoneo esposto
7
La Terapia a Pressione Negativa (TPN)
L’impatto delle lesioni cutanee in sanità
Attraverso la TPN, come precedentemente detto,
è possibile trattare diverse tipologie di lesioni cutanee
acute e croniche (figura 3)
Figura 3. Lesioni cutanee trattabili con la TPN
Croniche
Da pressione
(ulcere da
decubito, ulcere
neuropatiche*)
Infiammatorie
(vasculiti, disordini
cutanei primari)
Da insufficienza
vascolare
(flebopatie,
arteriopatie*,
lesioni miste,
linfopatie)
Acute
Da trauma
(meccanici,
ustionicongelamen
to, da radiazioni)
Post-operatorie
(toraciche,
addominali,
amputazioni)
Da altre cause
(infettive, morsi
animali ecc)
Lesioni maligne
Report N. 1 – HTA Assistenza Territoriale
(primitive e
secondarie)
La prevalenza e l‟incidenza delle lesioni cutanee
varia a seconda delle classi di età, della popolazione,
del setting, della definizione di caso che viene utilizzata e
della qualità delle cure.
Secondo alcune stime, le lesioni cutanee (acute e
croniche) interessano almeno l'1% della popolazione
(30). Tale problematica è particolarmente frequente per
alcune categorie di individui come quelli diabetici, gli
ipertesi, gli anziani, i pazienti sottoposti ad interventi
8
La Terapia a Pressione Negativa (TPN)
chirurgici ed in generale quelli ricoverati presso strutture
sanitarie.
Le lesioni cutanee croniche sono quelle a
maggior impatto economico e sanitario. Nella maggior
parte dei casi sono riferibili a lesioni da pressione (tra il 70
e l‟80% dei casi); seguono i pazienti con lesioni cutanee
vasculopatiche agli arti inferiori (10-15%), con lesioni post
chirurgiche (7-12%), neoplastiche (1-4%) e con ustioni (13%).
Per quanto riguarda le lesioni da pressione, che
rappresentano, tra quelle croniche, le lesioni a più alta
frequenza, i dati epidemiologici ci dicono che nei reparti
per acuti l‟incidenza puo variare dallo 0,4 al 38% (30);
nelle residenze sanitarie assistenziali (RSA) dal 2,2 al
23,9%, mentre nell‟ambito dell‟assistenza domiciliare
dallo 0 al 17% (127). In Italia i dati preliminari relativi ad
uno studio nazionale di prevalenza che ha valutato
13.081 pazienti ricoverati in 24 strutture ospedaliere, ha
documentato un tasso di prevalenza pari al 10,97%, Altri
studi condotti dall‟Associazione Infermieristica per lo
Studio delle Lesioni Cutanee (AISLeC) riportano dati di
prevalenza
intorno
al
13%
(247).
Un‟indagine
di
Report N. 1 – HTA Assistenza Territoriale
prevalenza del 2004 condotta dalla Agenzia di Sanita
9
Pubblica della Regione Lazio su un campione di 15 RSA
per un totale di 1.111 ospiti valutati con eta media di 79
anni, documenta una prevalenza complessiva del 6,9%
con il 67% delle lesioni ad insorgenza durante il soggiorno
in RSA e l‟11% durante un ricovero temporaneo in
ospedale (48).
Report N. 1 – HTA Assistenza Territoriale
La Terapia a Pressione Negativa (TPN)
10
La Terapia a Pressione Negativa (TPN)
IL GRUPPO REGIONALE SULL’HTA DISTRETTUALE E L’EVIDENCE
REPORT SULLA
TPN
Con delibera n.47 del 28 febbraio 2012 l‟AReS Puglia
ha individuato un gruppo multidisciplinare di lavoro, per
la valutazione HTA-based dell'assistenza territoriale e del
processo di integrazione tra ospedale e territorio", così
composto3:
-
Dr.
Gianfranco
Budano
–
Team
Leader
–
specialista area contabilità e controllo di gestione
(ASL LE);
-
Dr. Giuseppe Coratella – Direttore di Distretto
Socio
Sanitario
(ASL
BAT),
coordinatore
del
gruppo;
-
Dr.ssa Fiorella Digiuseppe – Dirigente Farmacista
(ASL di Bari);
-
Dr. Roberto Di Paola – Dirigente Medico U.O.
Controllo di Gestione (Policlinico di Bari);
-
Dr.ssa Angela Gesualdo – Assistente Sociale AReS
Puglia;
-
Dr.ssa Giuseppina Lauriola – Dirigente Medico del
Distretto Socio Sanitario di San Marco in Lamis (ASL
FG);
Report N. 1 – HTA Assistenza Territoriale
-
11
Dr.ssa Silvana Melli - componente in carica
gruppo HTA;
-
Dr. Salvatore Scorzafave – Medico specialista
epidemiologo – Convenzionato in Organizzazione
dei Servizi Sanitari di Base (ASL di Taranto).
L‟obiettivo
generale
del
gruppo
è
quello
di
individuare nuove tecnologie e prassi gestionali in grado
di ottimizzare il rapporto costo-beneficio delle attività
poste in essere a livello dei distretti socio sanitari.
3
Alla stesura del report ha partecipato, in qualità di collaboratore esterno, il
Dr. Gaetano L‟Assainato (ODT Taranto)
La Terapia a Pressione Negativa (TPN)
In questa cornice di attività si pone il lavoro riportato
nel presente documento e relativo alla TPN dal
momento che gran parte delle lesioni cutanee (specie
di tipo cronico) riguardano pazienti che vengono assistiti
attraverso servizi territoriali domiciliari (cure domiciliari
integrate) e residenziali (residenza sanitarie e sociosanitarie assistenziali).
L‟ipotesi di fondo, alla base del report, è che la TPN
possa rappresentare un trattamento di prima scelta per
la cura delle lesioni cutanee da preferire ai trattamenti
standard (figura 4) in quanto dotata di
maggiore
efficacia clinica con vantaggi per i pazienti da un lato e
per il sistema sanitario dall‟altro, dal momento che
possono essere ridotti gli accessi degli operatori, il
consumo di risorse ed essere prevenuti eventuali ricoveri
legati all‟evoluzione clinica degli assistiti.
Figura 4. Trattamenti standard per le lesioni cutanee acute e
croniche
Report N. 1 – HTA Assistenza Territoriale
LESIONI ACUTE
12
LESIONI CRONICHE
•Sulfadiazina argentica
•alginati
•idrocolloidi
•idrogel
•garza in soluzione salina 0,9% o
soluzione di Ringer
•Idrocolloide gel con garza
•Soluzioni gel (prodotti in gel (accuzyme,
iodosorb, panafil)
•Idrogel, alginati e bende di
compressione
La Terapia a Pressione Negativa (TPN)
Nel corso degli anni sono stati realizzati numerosi
studi per valutare la TPN in termini di efficacia, sicurezza
e costi. Nonostante l‟abbondante letteratura scientifica
a riguardo le evidenze per un impiego routinario della
TPN come terapia elettiva sono ancora contrastanti.
Con il presente report abbiamo dunque inteso
verificare lo stato dell‟arte della TPN, al 2012, in termini di
efficacia
clinica
(medicazioni
rispetto
semplici
ed
ai
trattamenti
avanzate
standard
così
come
sinteticamente riassunte nella figura 4); esso rappresenta
la prima fase di una più ampia linea di attività che
prevederà, in un momento successivo, anche un
evidence report sul rapporto costo-efficacia della
terapia, nell‟ottica di fornire una base informativa utile e
valida al fine di elaborare raccomandazioni e linee
Report N. 1 – HTA Assistenza Territoriale
guida per un utilizzo appropriato della TPN.
13
La Terapia a Pressione Negativa (TPN)
L’ANALISI DELLA LETTERATURA SCIENTIFICA
Per
le
predette
finalità
attraverso
le
principali
banche
è
stata
dati
realizzata,
bibliografiche
(Pubmed, Embase, Cochrane), una ricerca dei lavori
scientifici secondari (report HTA, metanalisi, evidence
report, revisioni sistematiche ) relativi alla TNP nel periodo
compreso tra il 2002 ed il 2012 (novembre) utilizzando le
seguenti parole chiave: topical negative pressure,
negative pressure wound therapy systems, vacuum
assisted closure, chronic wound OR chronic wounds,
acute wound OR acute wounds, abdominal wound OR
abdominal wounds, abdominal compartment syndrome,
open abdomen, diabetic foot ulcers, pressure ulcers,
sternal wound, chronic leg ulcers, skin graf OR skin grafts
OR skin grafting, wound infection.
Gli studi secondari considerati nel presente report,
si sono basati su lavori primari che hanno confrontato la
TPN alle terapie standard (figura 4), in termini di efficacia
clinica valutata attraverso un set di indicatori di
outcome (figura 5), per il trattamento di diverse tipologie
di lesioni. A riguardo va detto che gli studi secondari
hanno operato una aggregazione eterogenea delle
Report N. 1 – HTA Assistenza Territoriale
fonti primarie producendo evidenze aggregate per
14
lesioni acute e/o croniche. Solo in alcuni casi sono stati
realizzati studi secondari su lavori primari condotti per
specifiche tipologie di lesioni ed in particolar modo:
-
Ustioni;
-
ferite sternali;
-
lesioni diabetiche;
-
addome aperto;
-
lesioni da pressione;
-
lesioni traumatiche;
-
lesioni chirurgiche ed innesti.
La Terapia a Pressione Negativa (TPN)
Figura 5. Indicatori di outcome considerati negli studi primari per la
valutazione dell‟efficacia clinica della TPN
Indicatori di outcome
•riduzione del tempo di cicatrizzazione completa
•riduzione del ritmo di cambiamento nell‟area o
nel volume
•aumento
della
proporzione
di
lesioni
completamente cicatrizzate
•riduzione del tempo di preparazione della lesione
per la terapia chirurgica
•riduzione del dolore
•miglioramento qualità della vita (QUALY)
•aumento del tasso sopravvivenza/non rigetto di
innesti cutanei (solo per ustioni)
Contestualmente
alla
ricerca
degli
studi
secondari, ne è stata fatta una anche per individuare
singoli studi primari (trial clinici randomizzati, studi
descrittivi) pubblicati nel biennio 2011-2012 e non inclusi
in quelli secondari considerati.
L‟analisi della letteratura secondaria relativa al
periodo 2002-2012, ha portato all‟individuazione di 28
Report N. 1 – HTA Assistenza Territoriale
studi secondari (grafico 1) di cui:
15
-
N° 7 report di Health Technology Assesment (HTA);
-
N° 15 Revisioni Scientifiche (REV);
-
N° 2 Evidence Based Reccomandations (EBR);
-
N° 4 Metanalisi (META)
La Terapia a Pressione Negativa (TPN)
Grafico 1. Tipologia di studi secondari individuati per anno di
pubblicazione
Anno
2012
4
Report N. 1 – HTA Assistenza Territoriale
Anno
2011
16
2
Anno
2010
1
Anno
2009
1
2
Anno
2008
2
Anno
2007
2
Anno
2006
2
Anno
2005
1
Anno
2004
1
Anno
2003
1
2
2
2
2
1
Anno
0
2002
HTA
REV
EBR
META
L‟elenco degli studi secondari individuati viene
riportato nella figura 6.
La Terapia a Pressione Negativa (TPN)
Figura 6. Tipologia di studi secondari selezionati nel periodo 2002-2012
(anno della pubblicazione e riferimento bibliografico tra parentesi)
Revisioni
•2003 (96)
•2006 (190,237)
•2007 (245,325)
•2008 (127,313)
•2009 (212,307)
•2011 (230,304)
•2012 (111,223,266, 326)
HTA
•2003 (96)
•2004 (258)
•2005 (55)
•2006(143,186)
•2009 (209)
Metanalisi
•2008 (121,306)
•2010 (250)
•2011 (62,298)
EBR
•2011 (157,318)
Per quanto riguarda gli studi primari relativi al
biennio 2011-2012, abbiamo individuato 5 studi tra trial
clinici e descrittivi (figura 7).
Figura 7. Studi primari individuati nel periodo 2011-2012 (anno della
pubblicazione e riferimento bibliografico tra parentesi)
Report N. 1 – HTA Assistenza Territoriale
Studio Descrittivo
Trial clinico
2011
2011 (93,154,234)
(323, 329)
Il
dettaglio
degli
studi
secondari
e
primari
considerati, con l‟abstract in lingua originale, viene
riportato nelle tabelle sinottiche a partire da pagina 35.
L‟insieme delle fonti utilizzate (studi secondari e relativi
studi primari considerati riferiti al periodo 2002-2012 e
studi primari relativi al biennio 2011-2012) viene riportata
17
da pagina 69 nella bibliografia generale.
Report N. 1 – HTA Assistenza Territoriale
La Terapia a Pressione Negativa (TPN)
18
La Terapia a Pressione Negativa (TPN)
EVIDENZE
DALLA
LETTERATURA
SECONDARIA
(REPORT HTA,
REVIEW, METANALISI, EVIDENCE BASED RECCOMANDATIONS) NEL
PERIODO
2002-2012
La sintesi delle evidenze risultanti dagli studi secondari,
viene riportata nelle tabelle 2-10.
Tabella 2. Evidenze dei report HTA (lesioni acute e croniche).
Anno
2003
2005
2006
Report N. 1 – HTA Assistenza Territoriale
2006
19
2009
RB*
96
55
143
186
209
TS**
Sintesi delle evidenze
17
I risultati sono di bassa qualità (difetti
metodologici degli studi analizzati) e
forniscono una debole evidenza della
superiorità della TPN rispetto ai trattamenti
standard in termini di efficacia clinica.
19
Non emergono differenze statisticamente
significative tra TPN e trattamenti standard in
termini di outcome di salute. Il report
sottolinea inoltre la scarsa qualità degli studi
sotto il profilo metodologico concludendo
che l‟evidenza disponibile non supporta l‟uso
routinario della TPN.
22
Non ci sono al momento risultati di
riproducibilità adeguata che forniscono una
prova di superiorità della TNP in confronto ai
trattamenti standard e che giustificherebbero
un ampio uso di questo metodo al di fuori
delle
sperimentazioni cliniche.
23
A causa di limiti metodologici, i dati esistenti
dei trial controllati non supportano in modo
convincente un beneficio della TNP rispetto
ai trattamenti standard in termini di efficacia
clinica.
32
Mancano studi metodologicamente validi
per supportare I vantaggi della TPN rispetto ai
trattamenti standard. Si sottolinea inoltre la
mancanza di studi dedicati che hanno
confrontato i diversi kit di medicazione
utilizzati nella TPN.
* Riferimento Bibliografico
**Tabella sinottica
La Terapia a Pressione Negativa (TPN)
Tabella 3. Evidenze delle revisioni (lesioni acute e croniche)
Anno
2003
2004
2006
2006
Report N. 1 – HTA Assistenza Territoriale
2008
20
2008
2011
2012
RB*
135
258
190
237
127
306
230
266
TS**
Sintesi delle evidenze
16
I risultati suggeriscono che la TPN può avere
dei vantaggi rispetto ai trattamenti standard,
in termini di guarigione e chiusura di lesioni
croniche, anche se i limiti metodologici degli
studi primari considerati compromettono la
validità degli stessi risultati.
18
Gli studi primari considerati presentano difetti
metodologici e non consentono di delineare
una differenza significativa tra TPN e
trattamenti standard.
20
Singoli studi (case report, retrospettivi ecc.)
evidenziano una maggiore efficacia clinica
della TPN, rispetto ai trattamenti standard, su
un‟ampia
gamma
di
lesioni
acute/traumatiche, croniche, da infezione,
per il diabete mellito, sternali e vascolari. I trial
clinici però sono pochi e con risultati
contrastantii tali per cui non risulterebbe
giustificabile un uso routinario della TPN.
21
Sulla base dei dati disponibili, seppur ottenuti
da studi metodologicamente difettosi, la TPN
sembra avere una maggiore efficacia clinica
rispetto ai trattamenti standard e con poche
complicazioni serie.
26
Gli studi clinici primari considerati, presentano
difetti metodologici e come tali non
consentono di trarre conclusioni certe in
termini
di
differenze
statisticamente
significative tra TPN e trattamenti standard sia
in termini di guarigione delle ferite che di
ottimizzazione del rapporto costo-beneficio.
L‟evidenza suggerisce comunque che la TPN
è almeno tanto efficace quanto i trattamenti
a cui viene comparata. Pur con i limiti del
caso, il maggior vantaggio nell‟uso della TPN
si delineerebbe nel trattamento di lesioni
croniche.
28
I trial che confrontano la TNP con trattamenti
standard per lesioni croniche ed acute,
hanno difetti metodologici. I dati comunque
dimostrano un effetto benefico della TNP
sulla guarigione delle ferite anche se sono
necessarie indagini di migliore qualità.
38
Non vi sono consistenti evidenze di una
maggiore efficacia clinica della TPN rispetto
ai trattamenti standard. Ulteriori trial clinici
sono necessari.
48
L‟analisi sistematica dei dati mette in
evidenza una certa superiorità della TPN
rispetto ai trattamenti standard anche se si
rendono necessari ulteriori trial clinici per
verificarne adeguatamente il livello di
efficacia clinica.
* Riferimento Bibliografico
**Tabella sinottica
La Terapia a Pressione Negativa (TPN)
Tabella 4. Evidenze delle revisioni scientifiche (lesioni croniche)
Anno
2009
2011
2012
RB**
TS**
Sintesi delle evidenze
30
Gli studi primari considerati presentano difetti
metodologici
e
non
consentono
di
evidenziare in maniera netta la superiorità
della TPN in termini di efficacia clinica,
rispetto ai trattamenti standard. Ulteriori studi
sono necessari.
33
Non vi sono evidenze sufficienti sull‟efficacia
della TPN nel trattamento delle lesioni
croniche, e quindi la sua diffusione non è
giustificata.
45
C‟è un numero ragionevole di prove per
sostenere l‟utilizzo della TPN nel trattamento
delle lesioni cutanee croniche. La TPN può
essere una fonte utile per ridurre i costi di
gestioni delle lesioni croniche in quanto in
grado di accelerare la guarigione.
307
304
223
Tabella 5. Evidenze delle revisioni scientifiche (lesioni specifiche)
Anno
Report N. 1 – HTA Assistenza Territoriale
2007
RB*
325
TS**
Tipo di
lesione
24
Ustioni
Non si evidenziano, sulla base degli
studi primari inclusi, differenze
significative tra TPN e trattamenti
standard.
Le evidenze disponibili non sono al
momento in grado di supportare
l‟uso routinario della TPN nella
gestione delle ferrite sternali infette.
La TPN potrebbe rappresentare un
opzione
“clinicamente
interessante” come terapia di prima
linea nelle osteomieliti sternali in
pazienti ad elevato rischio.
2007
245
25
Ferite
sternali
dopo
interventi
cardiaci
2008
313
29
Lesioni da
pressione
Non vi sono evidenze nette a
supporto della superiorità della TPN
rispetto a trattamenti standard.
31
Addome
aperto
Non vi sono evidenze adeguate
circa una maggiore sicurezza ed
efficacia della TPN rispetto ai
trattamenti standard.
2009
212
2012
111
46
Lesioni
diabetiche
Ci sono evidenze relative al fatto
che la TPN possa favorire la
guarigione di ferite post-operatorie,
e prevenire la resezione di ulcere
neuropatiche plantari (diabetiche)
in maniera più efficace rispetto ai
trattamenti standard.
2012
326
47
Ferite
chirurgiche
ed innesti
Non vi sono prove a sufficienza
circa l‟efficacia della TPN per
questa tipologia di ferite.
* Riferimento Bibliografico
**Tabella sinottica
21
Sintesi delle evidenze
La Terapia a Pressione Negativa (TPN)
Tabella 6. Evidenze delle Metanalisi (lesioni acute e croniche)
Anno
2008
2010
RB*
121
250
TS**
Sintesi delle evidenze
27
Sebbene vi siano alcune indicazioni che la
TNP
possa avere un‟efficacia clinica
superiore, rispetto ai trattamenti standard, nel
favorire la guarigione delle lesioni acute e
croniche, l‟insieme delle evidenze disponibili
è insufficiente a provarlo.
34
Anche
se
permangono
alcuni
limiti
metodologici nella letteratura analizzata (in
particolare disomogeneità delle procedure
terapeutiche utilizzate nei gruppi di controllo
e
di
trattamento,
follow-up
breve,
disomogeneità
nella
definizione
degli
outcomes, disomogeneità nell'inclusione dei
pazienti) dalla nostra metanalisi dei dati
risultano sufficienti evidenze di efficacia della
terapia a pressione negativa nel ridurre il
tempo di guarigione, nell‟aumentare la
proporzione di ferite guarite, nel ridurre il
tempo di preparazione al trattamento
chirurgico. In particolare si hanno evidenze di
efficacia della terapia a pressione negativa:
1. per ferite acute post chirurgiche
difficili (sterno e addome aperto) o
con particolari fattori di rischio per la
cronicizzazione (amputazione del
piede diabetico);
2. come seconda linea di trattamento,
per lesioni cutanee croniche difficili
ad eccezione delle ulcere da
pressione.
Le evidenze disponibili per il trattamento delle
ulcere da pressione, seppure basate su studi
poco robusti, al momento sono di eguale
efficacia rispetto ai trattamenti standard.
Report N. 1 – HTA Assistenza Territoriale
Tabella 7. Evidenze delle Metanalisi (lesioni croniche)
22
Anno
2011
RB*
298
TS**
Sintesi delle evidenze
35
Si evidenzia una maggior efficacia della TPN
rispetto ai trattamenti standard, per il
trattamento delle ferite croniche. Nel gruppo
trattato con TPN le dimensioni della ferita
erano diminuite significativamente di più
rispetto al gruppo con terapia standard. Il
tempo
di
guarigione
è
stato
significativamente più breve nel gruppo
trattato con TPN. Questa prima metanalisi
sembra dunque fornire risultati più positivi
circa l‟efficacia della TPN rispetto ai
trattamenti standard anche se non possono
essere esclusi difetti legati a bias di
pubblicazione.
* Riferimento Bibliografico
**Tabella sinottica
La Terapia a Pressione Negativa (TPN)
Tabella 8. Evidenze delle Metanalisi (ferite sternali infette)
Anno
2011
RB*
62
TS**
Sintesi delle evidenze
36
Rispetto
ai
trattamenti
standard,
l‟applicazione della TPN alle ferite sternali
infette ha comportato una riduzione di 7,18
giorni in ospedale (intervallo di confidenza
(IC) 95%: 10.82, 3.54). Non vi sono differenze,
tra i due trattamenti in termini di mortalità.
Tabella 9. Evidenze delle EBR (lesioni acute e croniche)
Anno
2011
RB*
318
TS**
Sintesi delle evidenze
37
La base delle evidenze attuali è più forte per
l‟uso della TPN nel trattamento delle lesioni
croniche legate al diabete piuttosto che di
quelle vascolari (venose).
Tabella 10. Evidenze delle EBR (lesioni chirurgiche e traumatiche)
Anno
2011
RB*
157
TS**
Sintesi delle evidenze
39
La base di evidenza attuale è più forte per
l'uso della TPN su trapianti di pelle e più
debole come trattamento primario per le
ustioni.
Report N. 1 – HTA Assistenza Territoriale
* Riferimento Bibliografico
**Tabella sinottica
23
La Terapia a Pressione Negativa (TPN)
EVIDENZE
DALLA LETTERATURA PRIMARIA
(TRIAL
CLINICI, STUDI
DESCRITTIVI E COSTO-EFFICACIA) NEL BIENNIO 2011-2012
La sintesi delle evidenze risultanti dagli studi primari,
viene riportata nelle tabelle 11-14.
Tabella 11. Studio descrittivo retrospettivo sulle lesioni chirurgiche
infette, cutanee vascolari e da pressione
Anno
2011
RB*
323
TS**
Sintesi delle evidenze
40
Lo studio, condotto su 87 pazienti (età media
68 anni, range 16 - 92 anni) ha verificato una
maggior efficacia clinica della TPN nel
trattamento delle lesioni chirurgiche infette
rispetto alle lesioni cutanee vascolari e da
pressione (in termini di numero di pazienti
guariti) per le quali sono necessari studi
dedicati.
Tabella 12. Studio costo efficacia sulle lesioni cutanee legate al
diabete (piede diabetico)
Anno
Report N. 1 – HTA Assistenza Territoriale
2011
24
RB*
329
TS**
Sintesi delle evidenze
41
Lo studio è stato realizzato su una corte di
1000 pazienti con lesioni ulcerose diabetiche
seguiti per 1 anno in strutture sanitarie
francesi ed in cui è stata comparata, in
termini di efficacia clinica, la TPN alle terapie
avanzate. I pazienti trattati con TPN hanno
presentato, rispetto a quelli trattati con
terapie standard avanzate:
un numero maggiore di QALY (0,787
contro 0,784)
un tasso di guarigione delle lesioni
più elevato (50,2% versus 48,5%);
un costo totale delle cure per
paziente, in un anno, più basso
(24.881 € contro 28.855).
Tabella 13. Trial clinico su innesti cutanei
Anno
2011
RB*
234
TS**
Sintesi delle evidenze
43
Studio condotto su 40 pazienti sottoposti ad
innesti cutanei per ferite acute e croniche. La
TPN è stata confrontata con i trattamenti
standard. La TPN si rivela superiore ai
trattamenti standard in termini di quantità di
innesto, durata delle medicazioni e costo
complessivo.
* Riferimento Bibliografico
**Tabella sinottica
La Terapia a Pressione Negativa (TPN)
Tabella 14. Trial clinici in pazienti con lesioni cutanee legate al
diabete (piede diabetico)
Anno
2011
2011
RB*
154
93
TS**
Sintesi delle evidenze
42
Trial clinico su 67 pazienti. Il tempo di
guarigione nel gruppo di pazienti trattati con
TPN è risultato significativamente più basso di
quelli trattati con trattamenti standard
rispetto ai quali, i primi presentano punteggi
migliori nei questionari utilizzati per valutare lo
stato di salute e la qualità di vita. La TPN
risulta delinearsi come un trattamento
d‟elezione in questo particolare gruppo di
pazienti.
44
Trial clinico su 43 pazienti con lesioni cutanee
legate al diabete (piede diabetico). La TPN è
stata confrontata ai trattamenti standard
risultando più efficace in termini di:
percentuale di chiusure complete;
durata e frequenza di ricovero;
tasso di amputazione.
I risultati dello studio supportano quelli di altri
che hanno dimostrato una maggiore
efficacia della TPN, rispetto ai trattamenti
standard, nel trattamento delle ulcere del
piede diabetico.
Report N. 1 – HTA Assistenza Territoriale
* Riferimento Bibliografico
**Tabella sinottica
25
La Terapia a Pressione Negativa (TPN)
CONSIDERAZIONI GENERALI
L‟analisi comparativa tra TPN e terapie standard
(figura 4) attuata nei vari studi per la valutazione
dell‟efficacia
clinica, viene
influenzata
da
alcune
variabili principali che possiamo così riassumere:
-
tipo di lesione da trattare;
-
tipo di medicazione utilizzata: i dati disponibili
sembrerebbero evidenziare differenze di efficacia
a seconda del tipo di materiale utilizzato (243);
-
qualità e quantità degli studi considerati: gli studi
secondari mettono in risalto come la gran parte
dei
trial
clinici
presentino
e
difetti
delle
altre
fonti
metodologici
tali
primarie
da
non
consentire di trarre conclusioni nette; a ciò si
aggiunge poi il fenomeno degli studi interrotti e
non pubblicati ed i bias di pubblicazione (121).
Dal
andamento
2002
a
al
3
2012
fasi
abbiamo
per
ciò
osservato
che
concerne
un
la
pubblicazione degli studi primari4 (grafico 2):
-
la prima fase (1997-2002), che ha visto l‟avvio dei
primi studi clinici sull‟argomento;
-
la seconda fase (2003-2008), con un dibattito
Report N. 1 – HTA Assistenza Territoriale
scientifico
pieno
fervore
ed
in
cui
si
concentrano il maggior numero di studi;
-
la terza fase (dal 2009 ad oggi), caratterizzata da
una riduzione degli studi primari5 sempre più
orientati
ad
una
valutazione
più
selettiva
dell‟efficacia per specifiche tipologie di lesioni.
Ci si riferisce a quelli inclusi all‟interno degli studi secondari
considerati nel presente report.
5
Trial clinici randomizzati.
4
26
in
La Terapia a Pressione Negativa (TPN)
Grafico 2. Numero di studi primari per anno di pubblicazione
Fase 1
Fase 2
Fase 3
44
42
36
33
31
24
19
13
15
16
11
10
7
3
4
5
In virtù di tale andamento, gli studi secondari
(HTA, metanalisi, review) hanno potuto usufruire, con il
passar del tempo, di una base scientifica sempre più
solida in termini quali-quantitativi. Nella tabella 15
riportiamo il riepilogo degli studi secondari classificati in
base al livello di evidenza rilevato così come definito nei
criteri della National Academy of Clinical Biochemistry
Report N. 1 – HTA Assistenza Territoriale
(NACL)6 (Figura 8).
27
6
http://www.aacc.org/members/nacb/pages/default.aspx
La Terapia a Pressione Negativa (TPN)
Tabella 15. Riepilogo degli studi secondari considerati per tipo di
evidenza riscontrata secondo i criteri della NACL
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
Report N. 1 – HTA Assistenza Territoriale
2012
28
HTA
REV
META
HTA
REV
META
HTA
REV
META
HTA
REV
META
HTA
REV
META
HTA
REV
META
HTA
REV
META
HTA
REV
META
HTA
REV
META
HTA
REV
META
HTA
REV
META
Evidenza 1
111
62, 298
223
-
LEGENDA
Tipo di lesione
Lesioni acute e croniche
Lesioni croniche
Ferite chirurgiche sternali
Addome aperto
Altre ferite chirurgiche
Lesioni cutanee legate al diabete
Lesioni da pressione
Ustioni
Evidenza 2a
306
250*
266
-
Evidenza 2b
96
135
190,237
127
121
307
-
Evidenza 3
258
55
143,186
245, 325
313
209
212
250**
230, 304
326
-
Riferimento bibliografico
55,96,121,127,135,143,186,190,209,230,237,
258,266,306.
223,298,304,307
62,245,250*
212,250*
326
111,250*
250**,313
250**,325
La Terapia a Pressione Negativa (TPN)
Figura 8. Livelli di evidenza secondo i criteri della NACL
Evidenza 1
•Condizioni per le quali ci sono evidenze e/o un
consenso generale che una determinata
procedura o trattamento è utile ed efficace
Evidenza 2
•Condizioni per le quali vi sono evidenze in contrasto
e/o divergenze d‟opinione relativamente l‟utilità
e/o efficacia di una procedura od un trattamento
-2a: Il peso delle evidenze/opinioni appare in favore
dell’efficacia/efficienza
-2b: l’utilità/efficacia è di minore consistenza nelle
evidenze/opinione
Evidenza 3
•Condizioni per le quali c‟è evidenza e/o un
generale consenso che le procedure/trattamento
non è utile/efficace ed in alcuni casi può essere
pericoloso
-
Se analizziamo la letteratura secondaria che ha
preso in considerazione studi primari sulla valutazione
comparativa dell‟efficacia clinica di lesioni cutanee non
specifiche (e quindi di un‟aggregazione eterogenea di
lesioni acute e croniche) i risultati che si evidenziano
sono alquanto discordanti:
-
cinque studi secondari non riscontrano differenze,
in termini di efficacia, tra TPN e terapie tradizionali
(livello di evidenza 3): 2 revisioni (230,258) e 3
Report N. 1 – HTA Assistenza Territoriale
report HTA (55,143,209);
-
sei
studi
secondari
evidenziano
risultati
contrastanti con, complessivamente, un peso
delle evidenze non a favore della maggior
efficacia della TPN rispetto alle terapie tradizionali
(livello di evidenza 2b): 1 report HTA (96), 4
revisioni (127,135,190,237) ed una metanalisi (121);
-
due revisioni (266,306), riscontrano un insieme di
evidenze
che,
complessivamente
seppur
a
contrastanti,
favore
della
sono
maggior
efficacia della TPN rispetto alle terapie tradizionali
29
(livello di evidenza 2a).
La Terapia a Pressione Negativa (TPN)
Risultati contrastanti si hanno anche dagli studi
secondari che hanno considerato solo la macrocategoria delle lesioni croniche come oggetto della
valutazione comparata di efficacia:
-
una revisione del 2009 (307) con un livello di
evidenza 2b;
-
una revisione del 2011 che non ha riscontrato
evidenze a supporto della TPN (livello evidenza 3);
-
una metanalisi del 2011 (298) ed una revisione del
2012 (223) che hanno riscontrato evidenze a
supporto
della
maggior
efficacia
della
TPN
rispetto ai trattamenti tradizionali.
Riscontri più favorevoli alla TPN provengono dalle
metanalisi (che hanno effettuato un‟analisi quantitativa
dei dati degli studi primari al fine di supportare in
maniera più adeguata la valutazione dei risultati). Una
metanalisi del 2010 (250) riscontra evidenze di maggior
efficacia della TPN rispetto ai trattamenti standard
(evidenza 2a) per quanto riguarda lesioni acute post
chirurgiche difficili (sterno e addome aperto) o con
particolari
fattori
di
rischio
per
la
cronicizzazione
(amputazione del piede diabetico). Un‟altra metanalisi
Report N. 1 – HTA Assistenza Territoriale
del 2011, precedentemente citata (298), riscontra
30
evidenze di livello 1 a supporto della maggior efficacia
della TPN nel favorire i processi di guarigione e/o la
riduzione delle dimensioni della ferita nel caso di lesioni
croniche.
Complessivamente, i riscontri contrastanti emersi
dai predetti studi secondari (seppur con una tendenza
ad evidenze più positive a supporto della TPN negli studi
più recenti), che hanno considerato la TPN per il
trattamento di macro-categorie di lesioni (acute e/o
croniche)
vanno
interpretati
alla
luce
di
quanto
La Terapia a Pressione Negativa (TPN)
precedentemente detto in merito alle variabili che
influenzano la valutazione comparativa dell‟efficacia
clinica e quindi il tipo di lesione oggetto dell‟analisi
comparativa, il tipo di medicazione utilizzata per il
trattamento con TPN, il numero e la qualità degli studi
primari considerati nelle revisioni/metanalisi/report HTA.
Per quanto riguarda il livello delle evidenze
sull‟efficacia della TPN per il trattamento di lesioni
specifiche, riscontriamo quanto segue:
1. Lesioni cutanee legate al diabete: evidenze a
favore della maggior efficacia della TPN
rispetto alle terapie tradizionali sono fornite da
una metanalisi del 2010 (250), da una revisione
del 2008 poi aggiornata al 2011 (111), da una
EBR del 2011 (318). Esistono poi 3 studi primari
del 2011 di cui uno costo efficacia (329) e due
trial clinici (93,154) che hanno evidenziato una
maggiore efficacia clinica della TPN rispetto ai
trattamenti standard. Uno di questi studi in
particolare (154) ha anche stimato, per ogni
paziente
con
lesioni
diabete
trattato
con
cutanee
TPN
legate
anziché
al
con
Report N. 1 – HTA Assistenza Territoriale
trattamenti standard, un risparmio annuo di
circa 4000 euro;
2. lesioni da pressione: una revisione del 2008
(313) non ha riscontrato nessuna evidenza di
una
maggiore
efficacia,
tradizionali
della
superiorità,
TPN
(livello
in
rispetto
di
termini
alle
di
terapie
evidenza
3)
analogamente ad una metanalisi del 2010
(250);
3. ustioni: una revisione del 2007 (325) non ha
evidenziato superiorità in efficacia della TPN
31
La Terapia a Pressione Negativa (TPN)
(livello evidenza 3). Tale dato emerge anche
da una EBR del 2011 (157)
4. addome aperto: una revisione del 2009 (212)
non ha riscontrato nessuna evidenza di una
maggiore superiorità, in termini di efficacia,
della TPN rispetto alle terapie tradizionali (livello
di evidenza 3);
5. ferite sternali: una review del 2007 (245), non
ha riscontrato superiorità in termini di efficacia
della TPN rispetto alle terapie tradizionali (livello
di evidenza 3). Una metanalisi del 2011 (62) ha
evidenziato la superiorità della TPN rispetto ai
trattamenti
standard,
in
termini
efficacia
valutata attraverso la riduzione dei giorni di
Report N. 1 – HTA Assistenza Territoriale
degenza in ospedale.
32
La Terapia a Pressione Negativa (TPN)
CONCLUSIONI
I Distretti Socio Sanitari (DSS), attraverso l‟erogazione
di assistenza domiciliare, ambulatoriale e residenziale,
rappresentano un contesto sanitario in cui il potenziale di
utilizzo della TPN è molto elevato. Attraverso strumenti
terapeutici innovativi come la TPN, il DSS può svolgere un
ruolo cruciale, all‟interno del SSN, per l‟ottimizzazione
della spesa sanitaria ed il miglioramento dello stato di
salute degli assistiti. Alla base, al fine di poter conseguire
questi risultari, è necessario valutare tali terapie in termini
di efficacia pratica (effectiveness) e di sostenibilità
economica.
Il report da noi realizzato rappresenta la prima fase di
un processo valutativo più ampio della TPN, al fine di
supportare le azioni degli stakeholder e favorire un uso
appropriato della terapia all‟interno dei DSS.
In questo primo report abbiamo analizzato le
evidenze scientifiche relative all‟efficacia clinica della
TPN rispetto ai trattamenti tradizionali per la cura di
lesioni cutanee e croniche. I riscontri che abbiamo
ottenuto sono così riassumibili:
Report N. 1 – HTA Assistenza Territoriale
1. l‟efficacia clinica della TPN varia a seconda
delle lesioni cutanee trattate e può essere
influenzata dal tipo di medicazione utilizzata
nel sistema di TPN;
2. la base scientifica quali-quantitativa, su cui si
basano
le
evidenze
riscontrate,
presenta
diverse criticità che influenzano la validità
delle stesse (difetti metodologici degli studi
primari, elevato numero di trial clinici interrotti,
bias di pubblicazione, scarsità di studi che
hanno valutato le differenze - in termini di
33
La Terapia a Pressione Negativa (TPN)
efficacia
-
relative
all‟uso
di
differenti
medicazioni nei sistemi di TPN);
3. la maggior parte delle evidenze più forti (livello
2a e livello 1) a sostegno della maggior
efficacia clinica della TPN rispetto alle terapie
tradizionali, provengono da studi più recenti
(dal 2008 in poi);
4. sulla
base
dell‟analisi
della
letteratura
scientifica considerata, evidenze a supporto
dell‟uso
della
TPN,
rispetto
alle
terapie
tradizionali, si hanno per le lesioni cutanee
legate al diabete, lesioni croniche difficili (o
che non rispondono ai trattamenti tradizionali),
lesioni chirurgiche sternali. Evidenze deboli o
che non supportano l‟uso della TPN poiché di
efficacia equiparabile a quella delle terapie
tradizionali, si hanno per lesioni da pressione,
ustioni ed altre lesioni di tipo chirurgico
(addome aperto, innesti).
L‟obiettivo della seconda fase del nostro lavoro
sarà quello di realizzare un report che analizzi la
letteratura scientifica sulla TPN in termini di costi e costoReport N. 1 – HTA Assistenza Territoriale
efficacia al fine di migliorare la conoscenza circa la
34
sostenibilità economica relativa all‟utilizzo di tale terapia
nell‟ambito dei DSS. In particolare, rispetto ai tempi di
trattamento e di guarigione delle lesioni e su come
questi
possano
condizionare
sia
i
costi
che
l'organizzazione delle unita di assistenza domiciliare e il
turnover dei pazienti assistiti.
Report N. 1 – HTA Assistenza Territoriale
La Terapia a Pressione Negativa (TPN)
35
La Terapia a Pressione Negativa (TPN)
TABELLA 16. ANNO 2003 - REVISIONE – RIF. BIBLIOGRAFICO N° 135
Report N. 1 – HTA Assistenza Territoriale
The effectiveness of vacuum assisted closure in wound healing
Clayton, Victoria: Centre for Clinical
FONTE
Effectiveness (CCE)
AUTORI
Higgins S
The three articles identified and included in
this report represented four primary studies 2
in the systematic review), with 78 patients
randomised to receive vacuum assisted
closure (VAC)1 or another wound dressing.
Overall, the systematic review and one
randomised controlled trial suggest that VAC
may have advantages compared to other
forms of wound dressing studied in terms of
chronic wound healing and wound closure,
with one trial finding no difference in the time
forì wounds to reduce in volume by 50 per
cent. However, methodological limitations of
the two trials included in the systematic
review, and of the two further studies
ABSTRACT
appraised in this report limit the validity of
any conclusions that can be drawn from
them. No studies were identified which
reported outcomes such as patient mobility
levels or quality of life associated with VAC.
Presently, there have been too few reports
published of patients randomised to suggest
which patient groups may benefit most from
VAC, or what regimen is most efficacious. As
was highlighted by Evans & Land (2003) and
Wanner et al (2003), there is a need for well
designed, adequately powered, multi-centre
randomised
trials
to
evaluate
the
contribution of VAC in the management of
wounds.
36
La Terapia a Pressione Negativa (TPN)
TABELLA 17. ANNO 2003 - REPORT HTA – RIF. BIBLIOGRAFICO N° 96
Report N. 1 – HTA Assistenza Territoriale
Vacuum assisted wound closure therapy
Issues Emerg Health Technol 2003 Mar;(44):1FONTE
6.
AUTORI
Fisher A, Brady B.
Vacuum assisted closure (VAC) therapy is
designed to promote the formation of
granulation tissue for faster healing in the
wound beds of patients with acute and
chronic wounds. Four controlled trials and
one interim analysis provide poor quality
data and weak evidence that VAC therapy
ABSTRACT
may be superior to conventional methods
used in healing wounds. Complications with
VAC therapy are uncommon. Studies are
needed to evaluate the effectiveness of
VAC therapy when the types of dressings are
the same for patients in the groups being
compared and VAC therapy is the only
differing intervention.
37
La Terapia a Pressione Negativa (TPN)
TABELLA 18. ANNO 2004 – REVISIONE – RIF. BIBLIOGRAFICO N° 258
Healing Technologies: Low-Level Laser and Vacuum-Assisted
Closure.
AHRQ Publication No. 05-E005-2. December
FONTE
2004
AUTORI
Samson DJ, Lefevre F, Aronson N.
The objective of this evidence report is to
systematically review and synthesize the available
evidence on the effectiveness of low‐level laser
treatment and vacuum‐assisted closure for wound
healing. Outcomes of interest were:
Primary outcomes:
Incidence of complete wound closure.
Time to complete closure.
Adverse events.
Report N. 1 – HTA Assistenza Territoriale
ABSTRACT
38
Secondary outcomes:
Facilitating surgical closure.
Need for debridement.
Infections.
Pain.
Activities of daily living.
Quality of life.
Improved cosmesis.
Other secondary outcomes abstracted were
change in wound size and transcutaneous oxygen
tension (tcpO2); however, these were considered
to be of less clinical importance. his systematic
review focused on two specific interventions for
wound healing, but the issues raised in this
discussion should be applied broadly. Because of
the large size of populations with nonhealing and
other types of wounds, the impact on health care
expenditures is considerable. Future research
should address how to improve the delivery of
care, quality of care, and outcomes of treatment
of wounds in various settings. There is potential to
reduce the frequency of nonhealing wounds and
thus the overall costs of care. New interventions
have the potential to improve wound care, but
outcomes must be demonstrated in well‐
controlled randomized trials. Strategies for
reducing the occurrence of wounds in various
susceptible populations also have a place in the
research portfolio. Given significant costs of
chronic wounds, future comparisons of the cost‐
effectiveness of various strategies for preventing
wounds, managing wounds, and improving
quality of care would be of value to clinical
decisionmakers.
La Terapia a Pressione Negativa (TPN)
Report N. 1 – HTA Assistenza Territoriale
TABELLA 19. ANNO 2005 – REPORT HTA – RIF. BIBLIOGRAFICO N° 55
39
Vacuum-assisted wound closure therapy (V.A.C.).
Montreal, McGill University Health Centre,
FONTE
July 2005 (modified: March 2007)
AUTORI
Costa V, Brophy J, McGregor M.
The published comparative studies did not
show a consistent statistical or clinical
difference in meaningful health outcomes
between patients with complex wounds
treated with V.A.C. and other therapies. The
quality of the evidence is poor, with small
studies and inconsistent study methodology.
Therefore, we are lead to concur with the 5
other recent technology assessments and
one systematic review that the available
evidence does not support the routine use of
V.A.C. While V.A.C. may, under certain
circumstances, require less nursing time due
to less frequent dressing changes, any saving
in nursing time may be offset by the
increased material costs associated with
V.A.C. treatments. The strong opinion of users
that this therapy is beneficial cannot be
discounted. However, in the past TAU has
consistently adhered to the policy that the
introduction of an institutional policy that
involves the use of public funds demands
ABSTRACT
stronger evidence than would be necessary
for an individual physician or patient
deciding to undergo the same intervention.
For this reason, any extension of V.A.C.®
therapy should not be undertaken in the
absence of new evidence. At the same time
it would be consistent with the role of
academic leadership appropriate for the
MUHC to undertake a study to resolve the
discrepancy between local expert opinion
and the available evidence. No additional
V.A.C pumps should be purchased or rented
until clear evidence of efficacy becomes
available. In view of the conviction of users of
V.A.C. therapy at the MUHC that this therapy
is effective, the recent purchase of V.A.C.
equipment by the institution, and the
absence of compelling published evidence
of efficacy of V.A.C., the MUHC should
urgently
consider
undertaking
studies
designed to establish the value of this
treatment modality in the different clinical
situations in which it is employed.
La Terapia a Pressione Negativa (TPN)
TABELLA 20. ANNO 2006 – REVISIONE – RIF. BIBLIOGRAFICO N° 190
Report N. 1 – HTA Assistenza Territoriale
Negative-pressure wound therapy: a snapshot of the evidence
FONTE
Int Wound J 2006;3:261–271.
AUTORI
Mendonca DA, Papini R, Price PE.
Topical negative pressure (TNP) is a mode of
therapy used to encourage wound healing.
It can be used as a primary treatment for
chronic/complex wounds or as an adjunct to
surgery. Based on the evidence to date, the
clinical effectiveness of negative-pressure
therapy is still unclear. Although case reports
and
retrospective
studies
have
demonstrated enhanced wound healing in
acute/traumatic wounds, chronic wounds,
infected wounds, wounds secondary to
diabetes mellitus, sternal wounds and lower
limb wounds, there are very few randomised
controlled trials, with unclear results. The
ABSTRACT
evidence is lacking for the use of TNP therapy
for other indications to enhance wound
healing such as patients with decubitus
ulcers, diabetes and peripheral vascular
disease and to improve skin graft take. There
have been, as yet, no quality-of-life studies
available for negative-pressure therapy.
Despite this, the usage of TNP has increased.
This review provides an overview of clinical
studies using TNP and proposes avenues for
further research to elucidate the exact
mechanism of TNP, in addition to large
randomised controlled clinical trials of
patients undergoing this therapy.
40
La Terapia a Pressione Negativa (TPN)
TABELLA 21. ANNO 2006 – REVISIONE – RIF. BIBLIOGRAFICO N° 237
Report N. 1 – HTA Assistenza Territoriale
The safety and efficacy of topical negative pressure in nonhealing wounds: a systematic review
FONTE
Wound Care. 2006 Jun;15(6):240-50.
AUTORI
Pham CT, Middleton PF, Maddern GJ.
Evidence on topical negative pressure from
randomised controlled trials, non-randomised
comparative studies and case studies is
considered. This is the first systematic review
on this therapy to consider results by wound
ABSTRACT
type. There is a paucity of high-quality RCTs
of topical negative pressure for wound
management with sufficient sample size and
adequate power to detect any differences
between topical negative pressure and
standard dressings.
41
La Terapia a Pressione Negativa (TPN)
TABELLA 22. ANNO 2006 – REPORT HTA – RIF. BIBLIOGRAFICO N° 143
FONTE
AUTORI
Report N. 1 – HTA Assistenza Territoriale
ABSTRACT
42
Negative Pressure Wound Therapy
Institute for Quality and Efficiency in Health
Care. Year: 2006 No. 041
IQWiG
Full-text articles on clinical trials investigating
NPWT in patients with acute or chronic
wounds were searched for in MEDLINE,
EMBASE, CINAHL, and the Cochrane Central
Register of Controlled Trials. Trial registries
(www.clinicaltrials.gov and www.nrr.nhs.uk)
were also screened to identify ongoing trials.
Search strategies were adapted and
broadened according to the specific
structure of each database in order to
identify all published non-RCTs. In addition,
the Cochrane Library (CDSR, DARE, and HTA)
was searched to identify systematic reviews
on NPWT. All searches were last updated in
October 2005. Furthermore, the US Food and
Drug Administration (FDA), other health
agencies,
clinical
experts,
and
the
manufacturers of NPWT devices (Kinetic
Concepts, Inc. [KCI], San Antonio, TX; Blue
Sky Medical, La Costa, CA) were asked to
provide published and unpublished data.
Detailed information on the search strategies
is available in the full report (see below).
There are at present no results of adequate
reliability which provide proof of the
superiority of NPWT in comparison with
conventional therapy, and which would
justify broad use of this method outside
clinical trial settings. It would be advisable to
re-examine this question in 2 to 3 years.
La Terapia a Pressione Negativa (TPN)
TABELLA 23. ANNO 2006 – REPORT HTA – RIF. BIBLIOGRAFICO N° 186
Report N. 1 – HTA Assistenza Territoriale
Negative pressure wound therapy: an evidence-based
analysis
Ontario Health Technology Assessment Series
FONTE
2006;6(14).
AUTORI
Medical Advisory Secretariat
Based on the evidence to date, the clinical
effectiveness of NPWT to heal wounds is
unclear. Furthermore, saline dressings are not
standard practice in Ontario, thereby
rendering the literature base irrelevant in an
Ontario context. Nonetheless, despite the
lack of methodologically sound studies,
NPWT has diffused across Ontario. Discussions
with Ontario clinical experts have highlighted
some deficiencies in the current approach to
ABSTRACT
wound management, especially in the
community. Because NPWT is readily
available, easy to administer, and may save
costs,
compared
with
multiple
daily
conventional dressing changes, it may be
used inappropriately. The discussion group
highlighted the need to put in place a
coordinated, multidisciplinary strategy for
wound care in Ontario to ensure the best,
continuous care of patients.
43
La Terapia a Pressione Negativa (TPN)
Report N. 1 – HTA Assistenza Territoriale
TABELLA 24. ANNO 2007 – REVISIONE – RIF. BIBLIOGRAFICO N° 325
44
Topical negative pressure (TNP) for partial thickness burns
Cochrane Database of Systematic Reviews
FONTE
2007, Issue 3. Art. No.: CD006215. DOI:
10.1002/14651858. CD006215.pub2.
AUTORI
Wasiak J, Cleland H.
A burn wound is a complex and evolving
injury, with both local and systemic
consequences. Treatment includes using
variety of dressings, but newer strategies such
as topical negative pressure therapy have
been developed to try and promote the
wound healing process and minimize burn
wound progression to involve deeper tissue in
the acute phase. Topical negative pressure
uses a suction force to drain excess fluids. To
assess the effectiveness of TNP for those
people with partial thickness burns. We
searched the Cochrane Wounds Group
Specialised Register (searched April 2007),
the Cochrane Central Register of Controlled
Trials (CENTRAL)(The Cochrane Library Issue 2,
ABSTRACT
2007), Ovid MEDLINE (1950 to April Week 4
2007), Ovid EMBASE (1980 to Week 18 2007)
and Ovid CINAHL (1982 to April Week 4 2007).
All randomised controlled trials (RCTs) and
controlled clinical trials (CCTs) that evaluated
the safety and effectiveness of TNP for partial
thickness
burns.
Two
authors
using
standardised forms extracted the data
independently. Each trial was assessed for
internal validity with differences resolved by
discussion. A narrative synthesis of results was
undertaken as the absence of missing data,
poor reporting, or both precluded the
authors to undertake any formal statistical
analysis. One RCT satisfied the inclusion
criteria. The methodological quality of the
trial was poor.
La Terapia a Pressione Negativa (TPN)
Report N. 1 – HTA Assistenza Territoriale
TABELLA 25. ANNO 2007 – REVISIONE – RIF. BIBLIOGRAFICO N° 245
45
Should Vacuum-assisted closure therapy be routinely used for
management of deep sternal wound infection after cardiac
surgery?
Interact Cardiovasc Thorac Surg. 2007
FONTE
Aug;6(4):523-7. Epub 2007 Apr 20
AUTORI
Raja SG, Berg GA.
A best evidence topic in cardiac surgery was
written according to a structured protocol.
The question addressed was whether
vacuum-assisted closure (VAC) should be
routinely used for management of deep
sternal wound infection after cardiac surgery.
Altogether, 198 papers were identified using
the reported search. A further three relevant
papers were identified by hand searching
reference lists. Thirteen papers represented
the best evidence on the topic. The author,
journal, date and country of publication,
patient group studied, study type, relevant
outcomes, results and study weaknesses
were tabulated. We conclude that VAC
ABSTRACT
provides a viable and efficacious adjunctive
method by which to treat postoperative
wound infection after cardiac surgery. It is
especially useful for managing sternal
osteomyelitis in high-risk patients and is an
attractive option as a first-line therapy in this
group of patients. However, currently the
evidence to endorse its routine use for
management of deep sternal wound
infection after cardiac surgery is weak. A
randomised controlled trial comparing VAC
therapy with the conventional treatment is
mandatory to validate its safety, efficacy,
and cost effectiveness as a routine first-line
therapy for management of deep sternal
wound infection after cardiac surgery.
La Terapia a Pressione Negativa (TPN)
TABELLA 26. ANNO 2008 – REVISIONE – RIF. BIBLIOGRAFICO N° 127
FONTE
AUTORI
Report N. 1 – HTA Assistenza Territoriale
ABSTRACT
46
Vacuum Assisted Closure therapy
NHS, June 2008
Hammond C, Clift M.
Due to the methodological limitations of the
studies reviewed it is not possible to draw firm
conclusions. However, the evidence suggests
that VAC therapy is at least as effective as
the treatments it was compared with. The
majority of evidence does indicate a benefit
in comparison with „standard wound care‟
e.g. saline moist gauze, however the benefit
is less clear when compared with „advanced
wound care‟ e.g. hydrocolloids, alginates, in
the treatment of chronic and acute wounds.
CEP recommends that a high quality
independent randomised controlled trial is
conducted addressing the methodological
limitations of the studies highlighted in this
review. CEP also recommends that an
independent
economic
evaluation
is
undertaken, to include a sensitivity analysis.
Further examination of the effectiveness of
VAC therapy in the treatment of acute
wounds, and costs associated with the
treatment of wounds in a community setting,
is also required.
La Terapia a Pressione Negativa (TPN)
TABELLA 27. ANNO 2008 – METANALISI – RIF. BIBLIOGRAFICO N° 121
Report N. 1 – HTA Assistenza Territoriale
Negative pressure wound therapy: a vacuum of evidence?
47
FONTE
Arch Surg. 2008 Feb;143(2):189-96.
AUTORI
Gregor S, Maegele M, Sauerland S, Krahn JF,
Peinemann F, Lange S.
ABSTRACT
To systematically examine the clinical
effectiveness and safety of negative pressure
wound therapy (NPWT) compared with
conventional wound therapy. MEDLINE,
EMBASE, CINAHL, and the Cochrane Library
were
searched.
Manufacturers
were
contacted, and trial registries were screened.
Randomized controlled trials (RCTs) and nonRCTs comparing NPWT and conventional
therapy for acute or chronic wounds were
included in this review. The main outcomes of
interest were wound-healing variables. After
screening 255 full-text articles, 17 studies
remained. In addition, 19 unpublished trials
were found, of which 5 had been
prematurely terminated. Two reviewers
independently extracted data and assessed
methodologic quality in a standardized
manner. Seven RCTs (n = 324) and 10 nonRCTs (n = 278) met the inclusion criteria. The
overall methodologic quality of the trials was
poor. Significant differences in favor of NPWT
for time to wound closure or incidence of
wound closure were shown in 2 of 5 RCTs and
2 of 4 non-RCTs. A meta-analysis of changes
in wound size that included 4 RCTs and 2
non-RCTs favored NPWT (standardized mean
difference: RCTs, -0.57; non-RCTs, -1.30).
Although there is some indication that NPWT
may improve wound healing, the body of
evidence available is insufficient to clearly
prove an additional clinical benefit of NPWT.
The large number of prematurely terminated
and unpublished trials is reason for concern.
La Terapia a Pressione Negativa (TPN)
TABELLA 28. ANNO 2008 – REVISIONE – RIF. BIBLIOGRAFICO N° 306
A systematic review of topical negative pressure therapy for
acute and chronic wounds.
FONTE
Br J Surg. 2008 Jun;95(6):685-92.
AUTORI
Ubbink DT, Westerbos SJ, Nelson EA,
Vermeulen H.
Report N. 1 – HTA Assistenza Territoriale
ABSTRACT
48
Topical negative pressure (TNP) therapy is
becoming increasingly popular for all kinds of
wounds. Its clinical and cost effectiveness is
unclear. A search of randomized controlled
trials (RCTs) on TNP in adult patients with all
kinds of wounds in all settings was
undertaken in Medline, Embase, Cinahl (to
October 2007) and the Cochrane Library (to
issue 4, 2007). Information was also sought
from manufacturer of the VAC device.
Selection of trials for analysis, quality
assessment, data abstraction and data
synthesis were conducted by two authors
independently. The primary endpoint was
any measure of wound healing. Secondary
endpoints were infection, pain, quality of life,
oedema, microcirculation, bacterial load,
adverse events, duration of hospital stay and
cost. The search identified 15 publications on
13 RCTs. These reported on patients with
chronic wounds, diabetic wounds, pressure
ulcers, skin grafts and acute wounds. In
chronic and diabetic wounds, TNP did not
allow earlier complete wound healing. It was,
however, associated with a 1-10 day
reduction in the time needed to prepare the
wound for secondary closure surgery. In one
trial on acute wounds, 17 (95 per cent
confidence interval (c.i.) 0.02 to 0.32) per
cent more wounds appeared to heal with
TNP; the number needed to treat was six. This
was, however, at the cost of an 11 (95 per
cent c.i. 0.01 to 0.21) per cent higher
complication rate; the number needed to
harm was nine. There is little evidence to
support the use of TNP in the treatment of
wounds.
La Terapia a Pressione Negativa (TPN)
TABELLA 29. ANNO 2008 – REVISIONE – RIF. BIBLIOGRAFICO N° 313
The effectiveness of topical negative pressure in the treatment
of pressure ulcers: a literature review
FONTE
European Journal of Plastic Surgery April
2008, Volume 31, Issue 1, pp 1-7,
AUTORI
Mark van den Boogaard, Erik de Laat, Paul
Spauwen, Lisette Schoonhoven
Report N. 1 – HTA Assistenza Territoriale
ABSTRACT
49
The objective of the study was to gain insight
into the effectiveness of vacuum-assisted
closure (VAC) therapy or, more particularly,
topical negative pressure (TNP) in the
treatment of pressure ulcers. We carried out
a systematic search in Medline, Embase and
Cinahl for Randomized Clinical Trials (RCTs)
involving topical negative pressure in
pressure ulcers over the period 1992–2007.
Five RCTs were included. Two studies dealt
exclusively with pressure ulcers. No significant
differences in wound healing were found in
these studies. Three other studies (mixed
etiology of wounds) did show significant
differences in wound healing, in the
decrease of wound treatment time, and in
the decrease in number of bacteria. The
quality of these studies, both in terms of
methodology and otherwise, did not always
match with the scientific standard. Moreover,
these studies lacked subgroup analyses. The
analyzed studies described positive effects of
TNP, although both the control treatment
and the end points varied in these studies.
On the basis of the systematic assessment of
these five RCTs, the conclusion is that TNP has
not proven to be more effective than various
control
interventions.
The
differences
between and within the studies in terms of
control interventions, the differences in
randomization and a number of weaknesses
in the analyses do not allow a good
comparison. The main recommendations for
follow-up studies include: randomization of
patients rather than of wounds, a
homogeneous patient population, the use of
a single well-defined and procedurally
documented control intervention, and prior
calculation of the random sample size
La Terapia a Pressione Negativa (TPN)
TABELLA 30. ANNO 2009 – REVISIONE – RIF. BIBLIOGRAFICO N° 307
Topical negative pressure for treating chronic wounds
FONTE
Cochrane Database of Systematic Reviews
2009, Issue 3..
AUTORI
Ubbink DT, Westerbos SJ, Evans D, Land L,
Vermeulen H.
Report N. 1 – HTA Assistenza Territoriale
ABSTRACT
50
Chronic wounds mainly affect the elderly and
those with multiple health problems. Despite the
use of modern dressings, some of these wounds
take a long time to heal, fail to heal, or recur,
causing significant pain and discomfort to the
person and cost to health services. Topical
negative pressure (TNP) is used to promote healing
of surgical wounds by using suction to drain excess
fluid from wounds. To assess the effects of TNP on
chronic wound healing. For this second update of
this review we searched the Cochrane Wounds
Group Specialised Register (December 2007), The
Cochrane Central Register of Controlled Trials
(CENTRAL) - The Cochrane Library Issue 4, 2007,
Ovid MEDLINE In addition, we contacted authors,
companies, manufacturers, and distributors to
identify relevant trials and information. All
randomised controlled trials which evaluated the
effects of TNP on people with chronic wounds.
Selection of the trials, quality assessment, data
abstraction, and data synthesis were done by two
authors independently. Disagreements were
solved by discussion. Two trials were included in
the original review. A further five trials were
included in this second update resulting in a total
of seven trials involving 205 participants. The seven
trials compared TNP with five different comparator
treatments. Four trials compared TNP with gauze
soaked in either 0.9% saline or Ringer's solution. The
other three trials compared TNP with hydrocolloid
gel plus gauze, a treatment package comprising
papain-urea topical treatment, and cadexomer
iodine or hydrocolloid, hydrogels, alginate and
foam. These data do not show that TNP
significantly increases the healing rate of chronic
wounds compared with comparators. Data on
secondary outcomes such as infection rate,
quality of life, oedema, hospitalisation and
bacterial load were not reported. Trials comparing
TNP with alternative treatments for chronic
wounds have methodological flaws and data do
demonstrate a beneficial effect of TNP on wound
healing however more, better quality research is
needed.
La Terapia a Pressione Negativa (TPN)
TABELLA 31. ANNO 2009 – REVISIONE – RIF. BIBLIOGRAFICO N° 212
Negative pressure wound therapy for the open abdomen
FONTE
http://guidance.nice.org.uk/IPG322
AUTORI
Report N. 1 – HTA Assistenza Territoriale
ABSTRACT
51
National Institute for Health and Clinical
Excellence
This overview is based on 662 patients from
one randomised controlled trial1, two nonrandomised controlled trials, four case
series4–6 and one case report. Current
evidence on the safety and efficacy of
negative pressure wound therapy (NPWT) for
the open abdomen is inadequate in quality
and quantity. There has been concern about
the
occurrence
of
intestinal
fistulae
associated with this procedure but there is
currently no evidence about whether NPWT is
the cause. Therefore clinicians should make
special arrangements for audit of the
management of all patients with an open
abdominal wound, as recommended below.
La Terapia a Pressione Negativa (TPN)
TABELLA 32. ANNO 2009 – REPORT HTA – RIF. BIBLIOGRAFICO N° 209
Negative Pressure Wound Therapy Devices. Technology
Assessment Report.
FONTE
https://www.ecri.org/Documents/Press%20Rel
eases/Negative_Pressure_Wound_Therapy_D
evices.pdf
AUTORI
Institute under contract to the Agency for
Healthcare Research and Quality (AHRQ)
Report N. 1 – HTA Assistenza Territoriale
ABSTRACT
52
We identified a total of 22 other systematic
reviews, all published between 2000 and
2008, that covered NPWT devices. These
reviews included studies reporting data on
NPWT for patients with a broad range of
wound types and focused on comparison to
other wound treatments (gauze, bolster
dressings, wound gels, alginates, and other
topical therapies). The systematic reviews of
NPWT reveal several important points about
the current state of the evidence on this
technology. First, all of the systematic reviews
noted the lack of high-quality clinical
evidence supporting the advantages of
NPWT compared to other wound treatments.
The lack of high-quality NPWT evidence
resulted in many systematic reviewers relying
on low-quality retrospective studies to judge
the efficacy of this technology. Second, no
studies directly comparing different NPWT
components (such as foam vs. gauze
dressings) were identified by any of the
reviewers. All of the systematic reviews noted
the lack of high-quality clinical evidence
supporting the advantages of NPWT
compared to other wound treatments. No
studies directly comparing different NPWT
components (such as foam vs. gauze
dressings) were identified by any of the
reviewers
La Terapia a Pressione Negativa (TPN)
TABELLA 33. ANNO 2010 – REVISIONE – RIF. BIBLIOGRAFICO N° 304
Effectiveness, safety and cost-effectiveness of the negative
pressure wound therapy on the treatment of chronic wounds: a
systematic review
FONTE
Med Clin (Barc). 2011 Sep 17;137(7):321-8.
Epub 2010 Oct 2
AUTORI
Trujillo-Martín M, García-Pérez L, SerranoAguilar P
Report N. 1 – HTA Assistenza Territoriale
ABSTRACT
53
Negative-pressure wound therapy (NPWT) is
used to promote wound healing by using
suction to drain excess fluid from wounds. A
systematic literature review was undertaken
to assess the effectiveness, safety and costeffectiveness of NPWT for the treatment of
chronic wounds. Medline, Embase, CENTRAL,
CINAHL and the Cochrane Wounds Group
Specialised Trials Register were searched. A
total of 9 randomized controlled trials (n=568)
comparing NPWT with conventional wound
therapy and four economic evaluations
identified through NHS EED database were
included. Five trials showed significant
differences in favour of NPWT in primary
outcome measures; however, most studies
had small sample sizes and low scientific
validity. Complications and adverse effects
of NPWT are scarce compared to those of
conventional
treatment.
There
is
no
conclusive scientific evidence on the
effectiveness and cost-effectiveness of NPWT
in the treatment of chronic wounds and
therefore its widespread use is not justified.
La Terapia a Pressione Negativa (TPN)
TABELLA 34. ANNO 2010 – METANALISI – RI. BIBLIOGRAFICO N° 250
Trattamento delle lesioni cutanee,
acute e croniche, mediante utilizzo
della terapia a pressione negativa
FONTE
http://www.asplazio.it/asp_online/prev_for_d
oc/files/valutazione_HTA/Report_TNP10_09_10
.pdf
AUTORI
Agenzia di Sanità Pubblica Regione Lazio
Report N. 1 – HTA Assistenza Territoriale
ABSTRACT
54
Sono stati trovati 19 trial controllati, di cui 13
utili per valutare gli outcome considerati per
un totale di 893 pazienti. Sebbene rimangano
alcuni limiti metodologici nella letteratura
analizzata (in particolare disomogeneità
delle procedure terapeutiche utilizzate nei
gruppi di controllo e di trattamento, follow-up
breve, disomogeneità nella definizione degli
outcomes, disomogeneità nell'inclusione dei
pazienti) dalla nostra metanalisi dei dati
risultano sufficienti evidenze di efficacia della
terapia a pressione negativa nel ridurre il
tempo di guarigione (MD=-11,52 giorni;
IC95%[- 20,15;-2,88]) e nell‟aumentare la
proporzione di ferite guarite (RR=1,40;
IC95%[1,14;1,72]);
per
il
tempo
di
preparazione al trattamento chirurgico si ha
una riduzione di 5.7 giorni con significatività
borderline (MD=-5,74; IC95%[-12,43;0,96]). In
particolare si hanno evidenze di efficacia
della terapia a pressione negativa:
1. per ferite acute post chirurgiche difficili
(sterno e addome aperto) o con particolari
fattori di rischio per la cronicizzazione
(amputazione del piede diabetico);
2. come seconda linea di trattamento, per
lesioni
cutanee
croniche
difficili
ad
eccezione delle ulcere da pressione.
Le evidenze disponibili per il trattamento
delle ulcere da pressione, seppure basate su
studi poco potenti, al momento sono di
eguale efficacia rispetto alle terapie
standard.
La Terapia a Pressione Negativa (TPN)
TABELLA 35. ANNO 2011 – METANALISI – RIF. BIBLIOGRAFICO N° 298
Negative-pressure therapy versus standard wound care: a
meta-analysis of randomized trials.
FONTE
Plast Reconstr Surg. 2011 Nov;128(5):498e503e.
AUTORI
Suissa D, Danino A, Nikolis A.
Report N. 1 – HTA Assistenza Territoriale
ABSTRACT
55
Several
randomized
controlled
trials
comparing negative-pressure therapy to
standard wound care for chronic wounds
have been published. Although these studies
suggest a benefit for negative-pressure
therapy, the majority of the review articles on
the topic conclude that the studies are
inconclusive. The authors conducted a
quantitative
meta-analysis
of
the
effectiveness of negative-pressure therapy
for the management of chronic wounds. The
MEDLINE, EMBASE, and Cochrane databases
were searched from 1993 to March of 2010
for randomized controlled trials comparing
negative-pressure therapy to standard
wound care for chronic wounds. Measures of
wound size and time to healing, along with
the corresponding p values, were extracted
from the randomized controlled trials.
Relative change ratios of wound size and
ratios of median time to healing were
combined using a random effects model for
meta-analysis. Ten trials of negative-pressure
therapy versus standard wound care were
found. In the negative-pressure therapy
group,
wound
size
had
decreased
significantly more than in the standard
wound care group (relative change ratio,
0.77; 95 percent confidence interval, 0.63 to
0.96). Time to healing was significantly shorter
in the negative-pressure therapy group in
comparison with the standard wound care
group (ratio of median time to healing, 0.74;
95 percent confidence interval, 0.70 to 0.78).
This quantitative meta-analysis of randomized
trials suggests that negative-pressure therapy
appears to be an effective treatment for
chronic wounds. An effect of publication bias
cannot be ruled out.
La Terapia a Pressione Negativa (TPN)
TABELLA 36. ANNO 2011 – METANALISI – RIF. BIBLIOGRAFICO N° 62
Vacuum-assisted closure therapy for patients with infected
sternal wounds: a meta-analysis of current evidence.
FONTE
J Plast Reconstr Aesthet Surg. 2011
Sep;64(9):1119-23. Epub 2011 Jan 22.
AUTORI
Damiani G, Pinnarelli L, Sommella L, Tocco
MP, Marvulli M, Magrini P, Ricciardi W.
Report N. 1 – HTA Assistenza Territoriale
ABSTRACT
56
Acute and chronic wound infections are the
main reasons for the observed increase in
mortality rate and represent a significant risk
factor in hospitalisation. From the patient's
perspective,
wound
therapy
is
an
uncomfortable,
painful
and
long-term
treatment. Modern sternal-wound-treatment
systems would be expected to shorten
wound healing and hospital stay periods.
Vacuum-assisted closure (VAC) therapy is a
system that promotes wound healing through
the application of negative pressure by
controlled suction to the wound surface. The
application of controlled levels of negative
pressure accelerates healing in many types
of wounds. There are a number of scientific
publications that have used meta-analysis to
compare VAC and traditional therapy,
considering changes in wound size. This
article surveys the research literature
focussing on the management of wound
infections. The objective of this study is to
assess the impact of VAC compared with
conventional therapy on length of stay (LOS)
and mortality. Six articles were selected that
included a total of 321 patients (169 for VAC
therapy and 152 for conventional therapy).
The meta-analysis showed that VAC therapy
resulted in a decrease of 7.18 days in hospital
LOS (confidence interval (CI) 95%: 10.82,
3.54), with no significant impact on mortality.
Our data provide robust evidence of the
effectiveness of VAC therapy.
La Terapia a Pressione Negativa (TPN)
TABELLA 37. ANNO 2011 – EBR – RIF. BIBLIOGRAFICO N° 318
Evidence-based recommendations for the use of negative
pressure wound therapy in chronic wounds: steps towards an
international consensus
FONTE
J Tissue Viability. 2011 Dec;20 Suppl 1:S1-18.
Epub 2011 Nov 25
AUTORI
Vig S, Dowsett C, Berg L
Report N. 1 – HTA Assistenza Territoriale
ABSTRACT
57
Negative Pressure Wound Therapy (NPWT)
has become widely adopted over the last 15
years
and
over
1000
peer-reviewed
publications are available describing its use.
Despite this, there remains uncertainty
regarding several aspects of usage. In this
communication the results of the study of
evidence in chronic wounds including
pressure ulcers, diabetic foot ulcers (DFU),
venous leg ulcers (VLU), and ischaemic lower
limb wounds are reported. Evidence-based
recommendations were obtained by a
systematic review of the literature, grading of
evidence, drafting of the recommendations
by a global expert panel followed by a
formal consultative consensus development
program
in
which
422
independent
healthcare professionals were able to agree
or disagree with the recommendations. The
criteria for agreement were set at 80%
agreement. Evidence and recommendations
were graded according to the SIGN (Scottish
Intercollegiate
Guidelines
Network)
classification system. The primary treatment
goal of NPWT in most chronic wounds is to
achieve wound closure (either by secondary
intention or preparing the wound for surgical
closure). Secondary goals commonly include:
to reduce wound dimensions, and to improve
the quality of the wound bed. Thirteen
evidence based recommendations were
developed in total to address these
treatment goals; 4 for pressure ulcers, 4 for
DFU, 3 for ischaemic lower limb wounds and 2
for VLU. The present evidence base is
strongest for the use of NPWT in nonischaemic DFU and weakest in VLU. The
development
of
evidence-based
recommendations for NPWT with direct
validation from a large group of practicing
clinicians offers a broader basis for consensus
than work by an expert panel alone.
La Terapia a Pressione Negativa (TPN)
TABELLA 38. ANNO 2011 – REVISIONE – RIF. BIBLIOGRAFICO N° 230
Negative-pressure wound therapy: systematic review of
randomized controlled trials.
FONTE
Dtsch Arztebl Int. 2011 Jun;108(22):381-9.
Epub 2011 Jun 3
AUTORI
Peinemann F, Sauerland S
Report N. 1 – HTA Assistenza Territoriale
ABSTRACT
58
We found reports of 9 RCTs in addition to the
12 covered by earlier IQWiG reviews of this
topic. Five of the 9 new trials involved NPWT
systems that are not on the market. The
frequency of complete wound closure is
stated in only 5 of the 9 new reports; a
statistically significant effect in favor of NPWT
was found in only two trials.The results of 8 of
the 9 new trials are hard to interpret, both
because of apparent bias and because
diverse types of wounds were treated.
Although there may be a positive effect of
NPWT, we did not find clear evidence that
wounds heal any better or worse with NPWT
than with conventional treatment. Good
RCTs are still needed to evaluate NPWT.
La Terapia a Pressione Negativa (TPN)
TABELLA 39. ANNO 2011 – EBR – RIF. BIBLIOGRAFICO N° 157
Evidence-based recommendations for the use of Negative
Pressure Wound Therapy in traumatic wounds and
reconstructive surgery: steps towards an international
consensus.
FONTE
AUTORI
Report N. 1 – HTA Assistenza Territoriale
ABSTRACT
59
Injury. 2011 Feb;42 Suppl 1:S1-12.
Krug E, Berg L
Evidence-based recommendations were
obtained by a systematic review of the
literature, grading of evidence, drafting of
the recommendations by a global expert
panel, followed by a formal consultative
consensus development program in which
422 independent healthcare professionals
were able to agree or disagree with the
recommendations. The criteria for agreement
were set at 80% approval. Evidence and
recommendations were graded according
to
the
SIGN
(Scottish
Intercollegiate
Guidelines Network) classification system.
Twelve recommendations were developed in
total; 4 for soft tissue trauma and open
fracture injuries, 1 for burn injuries, 3 for flaps
and 4 for skin grafts. The present evidence
base is strongest for the use of NPWT on skin
grafts and weakest as a primary treatment
for burns. In the consultative process, 11/12 of
the proposed recommendations reached
the
80%
agreement
threshold.
The
development
of
evidence-based
recommendations for NPWT with direct
validation from a large group of practicing
clinicians offers a broader basis for consensus
than work by an expert panel alone.
La Terapia a Pressione Negativa (TPN)
Report N. 1 – HTA Assistenza Territoriale
TABELLA 40. ANNO 2011 - STUDIO PRIMARIO – RIF. BIBLIOGRAFICO 323
60
Negative pressure wound therapy - a descriptive study.
FONTE
Ostomy Wound Manage. 2011 Jun;57(6):22-9.
AUTORI
Wallin AM, Boström L, Ulfvarson J, Ottosson C.
To address a persistent lack of evidence
regarding the clinical outcomes of negative
pressure wound therapy (NPWT) and identify
which patient groups are most likely to
benefit
from
NPWT,
a
retrospective,
descriptive study was conducted to describe
outcomes of this treatment modality when
used in clinical practice. Charts from a
consecutive series of 87 patients (median
age 68 years, range 16 - 92 years) who
received NPWT during a period of 24 months
were abstracted to a statistical software file.
Patient
demographics,
history,
and
comorbidity variables as well as treatment
outcomes
were
obtained
from
the
computerized in- and outpatient record
system. Treatment outcomes were grouped
as successful (goal of care was met) or not
successful (goal of care was not met).
Successful treatment was noted for a total of
62 patients (71%) with a median treatment
ABSTRACT
time of 17 days. The proportion of patients
with a successful outcome was significantly
higher
in
patients
with
infectious,
postoperative, and traumatic wounds than in
patients with wounds related to peripheral
vascular disease or pressure ulcers (P = 0.001).
Treatment complications were observed in 18
patients (21%); five were related to infection.
Quality-of-life concerns were noted as a
reason for stopping treatment in four patients
and equipment problems were recorded for
two patients receiving NPWT in the home. This
study confirms previous re- search that NPWT
may be an effective and safe treatment
method for acute wounds but further studies
are needed to evaluate treatment efficacy
and effectiveness in patients with peripheral
vascular
disease
or
pressure-induced
wounds. Results also suggest that research
protocols should include patient quality-oflife outcomes.
La Terapia a Pressione Negativa (TPN)
TABELLA 41. ANNO 2011 – STUDIO PRIMARIO – RIF. BIBLIOGRAFICO N° 329
Report N. 1 – HTA Assistenza Territoriale
Economic evaluation of Vacuum Assisted Closure® Therapy for
the treatment of diabetic foot ulcers in France.
FONTE
Int Wound J. 2011 Feb;8(1):22-32.
Whitehead SJ, Forest-Bendien VL, Richard JL,
AUTORI
Halimi S, Van GH, Trueman P.
The objective of the study was to assess the
cost-effectiveness of Vacuum
Assisted
Closure® (V.A.C.®) Therapy compared with
advanced wound care (AWC) for the
treatment of diabetic foot ulcers (DFUs) in
France. A cost-effectiveness model intended
to reflect the management of DFUs was
updated for the French setting. The Markov
model follows the progression of 1000
hypothetical patients over a 1-year period.
The model was populated with Frenchspecific data, obtained from published
sources and clinical experts. The analysis
evaluated costs and health outcomes, in
terms of quality-adjusted life-years (QALYs),
wounds healed and amputations, from the
ABSTRACT
perspective of the payer. The patients
treated with V.A.C.® Therapy experienced
more QALYs (0.787 versus 0.784) and
improved healing rates (50.2% versus 48.5%)
at a lower total cost of care (€24,881 versus
€28,855 per patient per year) when
compared with AWC. Sensitivity analyses
conducted around key model parameters
indicated that the results were affected by
hospital resource use and costs. DFU
treatment using V.A.C.® Therapy in France
was associated with lower costs, additional
QALYs, more healed ulcers and fewer
amputations than treatment with AWC.
V.A.C.® Therapy was therefore found to be
the dominant treatment option.
61
La Terapia a Pressione Negativa (TPN)
Report N. 1 – HTA Assistenza Territoriale
TABELLA 42. ANNO 2011 – STUDIO PRIMARIO - RIF. BIBLIOGRAFICO N° 154
62
Vacuum assisted closure improves the quality of life in patients
with diabetic foot.
FONTE
Acta Chir Belg. 2011 Sep-Oct;111(5):298-302.
AUTORI
Karatepe O, Eken I, Acet E.
Diabetes Mellitus (DM) is the most common
endocrine disease worldwide. One of the
most important chronic complications of this
disease is the development of diabetic foot.
The management of diabetic foot wounds is
quite important with respect to public health.
To determine the effect of Vacuum Assisted
Closure (VAC) therapy on the quality of life in
the treatment of diabetic foot ulcers and
compare it with standart wound care.
Between May 2007 to December 2008, 67
consecutive patients with diabetic foot ulcers
were randomly assigned to VAC therapy
(Group 1, n : 30) or standart wound care
(Group 2, n : 37). The SF-36 questionnaire was
administered the day before and in the
month following wound healing. Global
analyses of the 8 domains and 2
comprehensive indexes of SF-36, Physical
Component Summary (PCS) and Mental
ABSTRACT
Component
Summary
(MCS)
were
performed. Clinical measures included
standard antidiabetic treatment, daily
wound care including antiseptic bath,
debridement, toe removal for gangrene
when necessary, and wound care with
conventional methods or VAC. Healing time
was calculated as the time from hospital
admission to the time of re-epithelization.
There were no differences in the mean age,
ulcer size and pulse status of the patients in
both groups. Healing time in the VAC group
was significantly reduced (p < 0.05). All 8
domains of SF-36 and MCS and PCS scores
improved remarkably after VAC therapy.
Vacuum Assisted Closure therapy was found
to be effective in the treatment of chronic
diabetic ulcers. The improvement of quality
of life demonstrates a clear-cut indication in
this particular group of patients.
La Terapia a Pressione Negativa (TPN)
TABELLA 43. ANNO 2011 – STUDIO PRIMARIO – RIF. BIBLIOGRAFICO N° 234
Report N. 1 – HTA Assistenza Territoriale
A prospective randomized controlled trial comparing negative
pressure dressing and conventional dressing methods on splitthickness skin grafts in burned patients.
FONTE
Burns. 2011 Sep;37(6):925-9. Epub 2011 Jul 1.
AUTORI
Petkar KS, Dhanraj P, Kingsly PM,
A total of 40 split-skin grafts were put on 30
patients. The grafted wounds included acute
and chronic burns wounds and surgically
created
raw
areas
during
burn
reconstruction. Twenty-one of them received
NPD and 19 served as controls. Patient
profiles and average size of the grafts were
comparable between the two groups. The
vacuum closure assembly was well tolerated
by all patients. Final graft take at nine days in
the study group ranged from 90 to 100 per
cent with an average of 96.7 per cent (SD:
3.55). The control group showed a graft take
ABSTRACT
ranging between 70 and 100 percent with an
average graft take of 87.5 percent (SD: 8.73).
Mean duration of continued dressings on the
grafted area was 8 days in cases (SD: 1.48)
and 11 days in controls (SD: 2.2) after surgery.
Each of these differences was found to be
statistically significant (p<0.001). Negative
pressure dressing improves graft take in burns
patients and can particularly be considered
when wound bed and grafting conditions
seem less-than-ideal. The negative pressure
can also be effectively assembled using
locally available materials thus significantly
reducing the cost of treatment.
63
La Terapia a Pressione Negativa (TPN)
Report N. 1 – HTA Assistenza Territoriale
TABELLA 44. ANNO 2011 – STUDIO PRIMARIO – RIF. BIBLIOGRAFICO N° 93
64
Vacuum-assisted therapy for various wound types including
diabetic foot ulcer
FONTE
Harefuah. 2011 Mar;150(3):222-6, 306, 305.
AUTORI
Farah R, Gantus M, Kogan L.
Vacuum is a noninvasive system that creates
a localized controlled negative pressure
environment. In this study, vacuum was
provided by the V.A.C. Therapy system,
which promotes wound healing by delayed
primary or secondary intention through
creating a moist wound environment,
preparing the wound bed for closure,
reducing edema, and promoting formation
and perfusion of granulation tissue. Vacuumassisted closure therapy is indicated for use in
all care settings and for a variety of wound
types including diabetic foot ulcers. The
purpose of this study was to evaluate safety
and clinical efficacy of negative pressure
wound therapy (NPWT) compared with
advanced moist wound therapy and
standard treatment to treat foot ulcers in
diabetic patients. This trial enrolled 43
patients; most of them were diabetic patients
at any age with various skin ulcers and
diabetic foot. These patients were divided
ABSTRACT
into two groups, 17 patients were treated
with vacuum and the 26 patients in the
control group were treated with standard
therapy including debridement. A greater
proportion of foot and skin ulcers achieved
complete ulcer closure with vacuum-assisted
therapy p<0.001 compared with the
standard
therapy.
Vacuum
therapy
significantly decreased the duration and
frequency of admission p=0.032 and
decreased the rate of amputation p<0.001.
Results of our trial support other studies and
demonstrate that vacuum is as safe as and
more efficacious than standard therapy in
the treatment of diabetic foot ulcers. A
significantly greater number of patients
achieved complete ulcer closure and
granulation tissue formation with this therapy.
The study group showed a significant
reduction in the median time needed to heal
ulcers, reduction of the number of admissions
and amputation frequency.
La Terapia a Pressione Negativa (TPN)
TABELLA 45. ANNO 2012 – REVISIONE – RIF. BIBLIOGRAFICO N° 223
Negative pressure wound therapy literature review of efficacy,
cost effectiveness, and impact on patients’ quality of life in
chronic wound management and its implementation in the
United Kingdom Plastic Surgery International
FONTE
AUTORI
Report N. 1 – HTA Assistenza Territoriale
ABSTRACT
65
Plastic Surgery International. Volume 2012
(2012), Article ID 374398, 6 pages
Othman D.
This is a paper reviewing the National Health
Service (NHS) agenda in relation to the use of
Negative Pressure Wound Therapy (NPWT) in
chronic wound management and assesses
the evidence behind it, its cost effectiveness
and the outcome it has on patients'
satisfaction and life style. Multiple studies over
the last 10 years looking at clinical efficacy of
NPWT with its cost effectiveness and the
implementation of this service in the UK were
reviewed. NPWT has showed a reasonable
body of evidence to support its usage in
chronic wounds with potential positive
outcomes
on
finance
and
patients'
satisfaction. However, the NHS system shows
significant variations in the availability and
implementation of this useful tool, depending
on care providers and resources availabilities.
The paper concluded that the NPWT can be
a useful source of cutting down costs of
chronic wound managements and saving
money by its effect on expediting wound
healing, which can address a part of the
financial crises facing the NHS, however, has
to be considered according to specific case
needs. There should also be a national
standard for the availability and indication of
this tool to assure equal opportunities for
different patients in different areas in the
country.
La Terapia a Pressione Negativa (TPN)
TABELLA 46. ANNO 2012 – REVISIONE – RIF. BIBLIOGRAFICO N° 111
A systematic review of interventions to enhance the healing of
chronic ulcers of the foot in diabetes
FONTE
AUTORI
Report N. 1 – HTA Assistenza Territoriale
ABSTRACT
66
Diabetes Metab Res Rev. 2012 Feb;28 Suppl
1:119-41.
Game FL, Hinchliffe RJ, Apelqvist J, Armstrong
DG, Bakker K, Hartemann A, Löndahl M, Price
PE, Jeffcoate WJ.
The present report is an update of the earlier
IWGDF systematic review, but the conclusion
is similar: that with the exception of HBOT
and, possibly, negative pressure wound
therapy, there is little published evidence to
justify the use of newer therapies. This echoes
the conclusion of a recent Cochrane review
and the systematic review undertaken by the
National Institute for Health and Clinical
Excellence Guidelines Committee in the UK.
Analysis of evidence presents considerable
difficulties in this field particularly as
controlled studies are few and the majority
are of poor methodological quality.
La Terapia a Pressione Negativa (TPN)
TABELLA 47. ANNO 2012 – REVISIONE – RIF. BIBLIOGRAFICO N° 326
Report N. 1 – HTA Assistenza Territoriale
Negative pressure wound therapy for skin grafts and surgical
wounds healing by primary intention
67
FONTE
Cochrane Database Syst Rev. 2012 Apr
18;4:CD009261.
AUTORI
Webster J, Scuffham P, Sherriff KL, Stankiewicz
M, Chaboyer WP.
ABSTRACT
Evidence for the effectiveness of NPWT on
complete healing of wounds expected to
heal by primary intention remains unclear.
Rates of graft loss may be lower when NPWT
is used; but evidence to date suggests that
hospital-based products are as effective in
this area as commercial applications. There
are clear cost benefits when non-commercial
systems are used to create the negative
pressure required for wound therapy, with no
reduction in clinical outcome. Pain levels are
also rated lower when hospital systems are
compared
with
their
commercial
counterparts. The high incidence of blisters
occurring when NPWT is used following
orthopaedic surgery suggests that the
therapy should be limited until safety in this
population is established. Given the cost and
widespread use of NPWT, there is an urgent
need for suitably powered, high-quality trials
to evaluate the effects of the newer NPWT
products that are designed for use on clean,
closed surgical incisions. Such trials should
focus initially on wounds that may be difficult
to heal, such as sternal wounds or surgeries
for obese patients.
La Terapia a Pressione Negativa (TPN)
TABELLA 48. ANNO 2012 – REVISIONE – RIF. BIBLIOGRAFICO N° 266
Negative pressure therapy: theory and practice.
FONTE
AUTORI
Report N. 1 – HTA Assistenza Territoriale
ABSTRACT
68
Diabetes Metab Res Rev. 2012 Feb;28 Suppl
1:72-7.
Schintler MV
Systematic analysis of the data shows
efficacy concerning induction of wound
healing mechanisms, especially in the early
stage.
Increased
perfusion
can
be
considered proven. Data analysis shows
positive efficacy for treatment of infection.
Although this therapy appears effective and
its superiority to conventional techniques has
been demonstrated, there are still some
critical votes concerning efficacy. Because
its mechanisms of action remain unclear, and
because there is still some gap between
evidence-based data and the excellent
clinical
results,
further
prospective,
randomized, blinded studies are needed.
Even so, we conclude that vacuum therapy,
used when indicated and especially by
experienced surgeons, is an excellent tool to
support wound healing.
La Terapia a Pressione Negativa (TPN)
Report N. 1 – HTA Assistenza Territoriale
BIBLIOGRAFIA GENERALE
69
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Adamkova M, Tymonova J, Zamecnikova I,
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Agarwal JP, Ogilvie M, Wu LC, Lohman RF,
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Apelqvist J, Armstrong DG, Lavery LA, Boulton
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Armstrong DG, Lavery LA, Abu-Rumman P,
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Armstrong DG, Lavery LA. Negative pressure
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Armstrong DG, Marston WA, Reyzelman AM,
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Avery C, Pereira J, Moody A, Gargiulo M,
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