Terapija rana negativnim pritiskom za zacjeljivanje hirurških rana primarnim zatvaranjem.
The Cochrane database of systematic reviews
Sažetak istraživanja
Pozadina Indikacije za upotrebu terapije rana negativnim pritiskom (NPWT) su široke i uključuju profilaksu infekcija hirurških mesta (SSI). Postojeći dokazi o efikasnosti NPWT-a na zacjeljivanje postoperativnih rana primarnim zatvaranjem ostaju neizvjesni.
Ciljevi Procijeniti efekte NPWT za sprječavanje SSI u zacjeljivanju rana kroz primarno zatvaranje i procijeniti isplativost NPWT u zacjeljivanju rana kroz primarno zatvaranje.
Metode pretraživanja U januaru 2021. pretražili smo Cochrane specijalizovani registar za rane; Cochrane Centralni registar kontrolisanih ispitivanja (CENTRAL); Ovid MEDLINE (uključujući Citate u procesu i druge neindeksirane citate); Ovid Embase i EBSCO CINAHL Plus. Također smo pretražili registre kliničkih ispitivanja i reference uključenih studija, sistematske preglede i izvještaje o zdravstvenoj tehnologiji. Nije bilo ograničenja u pogledu jezika, datuma objavljivanja ili postavke studija. Kriterijumi odabira Uključili smo ispitivanja ako su nasumično raspoređivali učesnike na tretman i upoređivali NPWT sa bilo kojom drugom vrstom zavoja za ranu, ili upoređivali jedan tip NPWT sa drugim. Prikupljanje i analiza podataka Najmanje dva autora pregleda su nezavisno procjenjivala ispitivanja koristeći unaprijed određene kriterije uključivanja. Izvršili smo ekstrakciju podataka, procjenu korištenjem Cochrane alata za rizik od pristrasnosti i procjenu kvaliteta prema metodologiji ocjenjivanja preporuka, procjene, razvoja i evaluacije. Naši primarni ishodi bili su SSI, mortalitet i dehiscencija rana. Glavni rezultati U ovom četvrtom ažuriranju dodali smo 18 novih randomiziranih kontroliranih studija (RCT) i jednu novu ekonomsku studiju, što je rezultiralo sa ukupno 62 RCT-a (13.340 uključenih učesnika) i šest ekonomskih studija. Studije su procjenjivale NPWT u širokom rasponu operacija, uključujući ortopedske, opstetričke, vaskularne i opće procedure. Sve studije su poredile NPWT sa standardnim zavojima. Većina studija je imala nejasan ili visok rizik od pristranosti za barem jednu ključnu domenu. Primarni ishodi Objedinjeno je jedanaest studija (6384 učesnika) koje su prijavile smrtnost. Postoje dokazi niske sigurnosti koji pokazuju da može postojati smanjeni rizik od smrti nakon operacije za osobe liječene NPWT (0,84%) u poređenju sa standardnim zavojima (1,17%), ali postoji nesigurnost oko toga jer intervali povjerenja uključuju rizik od koristi i štete; omjer rizika (RR) 0,78 (95% CI 0,47 do 1,30; I 2 = 0%). Pedeset četiri studije su objavile SSI; 44 studije (11.403 učesnika) su objedinjene. Postoje dokazi sa umjerenom sigurnošću da NPWT vjerovatno rezultira manjim brojem SSI (8,7% učesnika) nego liječenje standardnim zavojima (11,75%) nakon operacije; RR 0,73 (95% CI 0,63 do 0,85; I 2 = 29%). Trideset studija je prijavilo dehiscenciju rane; 23 studije (8724 učesnika) su objedinjene. Postoje dokazi sa umjerenom sigurnošću da vjerovatno postoji mala ili nikakva razlika u dehiscenciji između ljudi liječenih NPWT (6,62%) i onih koji su liječeni standardnim zavojima (6,97%), iako postoji nepreciznost oko procjene koja uključuje rizik od koristi i štete; RR 0,97 (95% CI 0,82 do 1,16; I 2 = 4%). Dokazi su smanjeni zbog nepreciznosti, rizika od pristrasnosti ili kombinacije ovoga. Sekundarni ishodi Postoje dokazi niske sigurnosti za ishode reoperacije i seroma; u svakom slučaju, intervali povjerenja su uključivali i korist i štetu. Možda postoji smanjeni rizik od ponovne operacije u korist standardne zavojne ruke, ali to je bilo neprecizno: RR 1,13 (95% CI 0,91 do 1,41; I 2 = 2%; 18 pokušaja; 6272 učesnika). Može postojati smanjeni rizik od seroma kod ljudi koji su liječeni NPWT, ali ovo je neprecizno: RR je bio 0,82 (95% CI 0,65 do 1,05; I 2 = 0%; 15 ispitivanja; 5436 učesnika). Što se tiče kožnih plikova, postoje dokazi sa malom sigurnošću da ljudi liječeni NPWT mogu imati veću vjerovatnoću da će razviti kožne plikove u usporedbi s onima koji su liječeni standardnim zavojima (RR 3.55; 95% CI 1.43 do 8.77; I 2 = 74%; 11 ispitivanja; 5015 učesnika). Učinak NPWT-a na hematom je neizvjestan (RR 0,79; 95 % CI 0,48 do 1,30; I 2 = 0%; 17 ispitivanja; 5909 učesnika; dokazi vrlo niske sigurnosti). Postoje dokazi male ili nikakve razlike u prijavljenim bolovima između grupa. Bol je mjeren na različite načine i većina studija nije mogla biti objedinjena; ova GRADE procena je zasnovana na svih četrnaest studija koje prijavljuju bol; zbirni RR za udio učesnika koji su iskusili bol bio je 1,52 (95% CI 0,20, 11,31; I 2 = 34%; dvije studije; 632 učesnika). Isplativost Šest ekonomskih studija, zasnovanih u potpunosti ili djelimično na ispitivanjima u našem pregledu, procijenilo je isplativost NPWT u poređenju sa standardnom njegom. Oni su razmatrali NPWT u pet indikacija: carski rez kod gojaznih žena; operacija prijeloma donjih ekstremiteta; artroplastika koljena/kuka; premosnici koronarne arterije; i vaskularna hirurgija sa ingvinalnim rezovima. Izračunali su godine života prilagođene kvaliteti ili ekvivalent, i proizveli procjene relativne isplativosti tretmana. Kvalitet izvještavanja je bio dobar, ali je sigurnost dokaza varirala od umjerene do vrlo niske. Postoje dokazi umjerene sigurnosti da NPWT u operaciji prijeloma donjih ekstremiteta nije bio isplativ ni na jednom pragu spremnosti da se plati i da je NPWT vjerovatno isplativ kod gojaznih žena koje su bile podvrgnute carskom rezu. Druge studije su pronašle dokaze niske ili vrlo niske sigurnosti koji ukazuju na to da NPWT može biti isplativ za procijenjene indikacije.
Zaključci autora Ljudi sa primarnim zatvaranjem hirurške rane i profilaktički liječeni NPWT nakon operacije vjerovatno imaju manje SSI nego ljudi liječeni standardnim zavojima, ali vjerovatno nema razlike u dehiscenciji rane (dokazi umjerene sigurnosti). Može postojati smanjeni rizik od smrti nakon operacije za osobe liječene NPWT u poređenju sa standardnim zavojima, ali postoji nesigurnost oko toga jer intervali povjerenja uključuju rizik od koristi i štete (dokazi niske sigurnosti). Ljudi liječeni NPWT-om mogu doživjeti više slučajeva stvaranja plikova na koži u poređenju sa standardnim tretmanom zavoja (dokazi niske sigurnosti). Nema jasnih razlika u drugim sekundarnim ishodima gdje je većina dokaza niska ili vrlo niska izvjesnost. Procjene isplativosti NPWT-a dale su različite rezultate u različitim indikacijama. U toku je veliki broj studija čiji rezultati mogu promijeniti nalaze ovog pregleda. Odluke o upotrebi NPWT-a treba da uzmu u obzir hiruršku indikaciju i postavljanje i uzmu u obzir dokaze za sve ishode.
Prikaži originalni naslov i sažetak na engleskom
Negative pressure wound therapy for surgical wounds healing by primary closure.
Background Indications for the use of negative pressure wound therapy (NPWT) are broad and include prophylaxis for surgical site infections (SSIs). Existing evidence for the effectiveness of NPWT on postoperative wounds healing by primary closure remains uncertain.
Objectives To assess the effects of NPWT for preventing SSI in wounds healing through primary closure, and to assess the cost-effectiveness of NPWT in wounds healing through primary closure. Search methods In January 2021, we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including In-Process & Other Non-Indexed Citations); Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trials registries and references of included studies, systematic reviews and health technology reports. There were no restrictions on language, publication date or study setting. Selection criteria We included trials if they allocated participants to treatment randomly and compared NPWT with any other type of wound dressing, or compared one type of NPWT with another. Data collection and analysis At least two review authors independently assessed trials using predetermined inclusion criteria. We carried out data extraction, assessment using the Cochrane risk of bias tool, and quality assessment according to Grading of Recommendations, Assessment, Development and Evaluations methodology. Our primary outcomes were SSI, mortality, and wound dehiscence. Main results In this fourth update, we added 18 new randomised controlled trials (RCTs) and one new economic study, resulting in a total of 62 RCTs (13,340 included participants) and six economic studies. Studies evaluated NPWT in a wide range of surgeries, including orthopaedic, obstetric, vascular and general procedures. All studies compared NPWT with standard dressings. Most studies had unclear or high risk of bias for at least one key domain. Primary outcomes Eleven studies (6384 participants) which reported mortality were pooled. There is low-certainty evidence showing there may be a reduced risk of death after surgery for people treated with NPWT (0.84%) compared with standard dressings (1.17%) but there is uncertainty around this as confidence intervals include risk of benefits and harm; risk ratio (RR) 0.78 (95% CI 0.47 to 1.30; I 2 = 0%). Fifty-four studies reported SSI; 44 studies (11,403 participants) were pooled. There is moderate-certainty evidence that NPWT probably results in fewer SSIs (8.7% of participants) than treatment with standard dressings (11.75%) after surgery; RR 0.73 (95% CI 0.63 to 0.85; I 2 = 29%). Thirty studies reported wound dehiscence; 23 studies (8724 participants) were pooled. There is moderate-certainty evidence that there is probably little or no difference in dehiscence between people treated with NPWT (6.62%) and those treated with standard dressing (6.97%), although there is imprecision around the estimate that includes risk of benefit and harms; RR 0.97 (95% CI 0.82 to 1.16; I 2 = 4%). Evidence was downgraded for imprecision, risk of bias, or a combination of these. Secondary outcomes There is low-certainty evidence for the outcomes of reoperation and seroma; in each case, confidence intervals included both benefit and harm. There may be a reduced risk of reoperation favouring the standard dressing arm, but this was imprecise: RR 1.13 (95% CI 0.91 to 1.41; I 2 = 2%; 18 trials; 6272 participants). There may be a reduced risk of seroma for people treated with NPWT but this is imprecise: the RR was 0.82 (95% CI 0.65 to 1.05; I 2 = 0%; 15 trials; 5436 participants). For skin blisters, there is low-certainty evidence that people treated with NPWT may be more likely to develop skin blisters compared with those treated with standard dressing (RR 3.55; 95% CI 1.43 to 8.77; I 2 = 74%; 11 trials; 5015 participants). The effect of NPWT on haematoma is uncertain (RR 0.79; 95 % CI 0.48 to 1.30; I 2 = 0%; 17 trials; 5909 participants; very low-certainty evidence). There is low-certainty evidence of little to no difference in reported pain between groups. Pain was measured in different ways and most studies could not be pooled; this GRADE assessment is based on all fourteen trials reporting pain; the pooled RR for the proportion of participants who experienced pain was 1.52 (95% CI 0.20, 11.31; I 2 = 34%; two studies; 632 participants). Cost-effectiveness Six economic studies, based wholly or partially on trials in our review, assessed the cost-effectiveness of NPWT compared with standard care. They considered NPWT in five indications: caesarean sections in obese women; surgery for lower limb fracture; knee/hip arthroplasty; coronary artery bypass grafts; and vascular surgery with inguinal incisions. They calculated quality-adjusted life-years or an equivalent, and produced estimates of the treatments' relative cost-effectiveness. The reporting quality was good but the evidence certainty varied from moderate to very low. There is moderate-certainty evidence that NPWT in surgery for lower limb fracture was not cost-effective at any threshold of willingness-to-pay and that NPWT is probably cost-effective in obese women undergoing caesarean section. Other studies found low or very low-certainty evidence indicating that NPWT may be cost-effective for the indications assessed. Authors' conclusions People with primary closure of their surgical wound and treated prophylactically with NPWT following surgery probably experience fewer SSIs than people treated with standard dressings but there is probably no difference in wound dehiscence (moderate-certainty evidence). There may be a reduced risk of death after surgery for people treated with NPWT compared with standard dressings but there is uncertainty around this as confidence intervals include risk of benefit and harm (low-certainty evidence). People treated with NPWT may experience more instances of skin blistering compared with standard dressing treatment (low-certainty evidence). There are no clear differences in other secondary outcomes where most evidence is low or very low-certainty. Assessments of cost-effectiveness of NPWT produced differing results in different indications. There is a large number of ongoing studies, the results of which may change the findings of this review. Decisions about use of NPWT should take into account surgical indication and setting and consider evidence for all outcomes.
Izvorni podaci
- DOI
- 10.1002/14651858.cd009261.pub7
- PMID
- 35471497
- PMCID
- PMC9040710
- Provjereno
- 2026-07-26
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