10.1001/TESTjama.2012.4607

Vollständiger Abstract

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IMPORTANCE: Incisional negative pressure wound therapy (iNPWT) has been proposed as a nonantibiotic adjunct to standard dressings for preventing surgical site infection (SSI), but uncertainty remains regarding consistency across SSI subtypes and dressing-related harms. OBJECTIVE: To evaluate the efficacy and safety of iNPWT vs standard dressing in adults undergoing surgery. DATA SOURCES: PubMed, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) were searched from inception through March 7, 2026. STUDY SELECTION: Randomized clinical trials (RCTs) enrolling adults in whom iNPWT was applied to primarily closed surgical incisions and compared with standard dressing. DATA EXTRACTION AND SYNTHESIS: Two reviewers independently extracted data. Risk ratios (RRs) and mean differences with 95% CIs were pooled using random-effects models. MAIN OUTCOMES AND MEASURES: The primary outcome was overall SSI. Secondary outcomes included SSI subtypes, wound dehiscence, seroma, skin necrosis, reoperation, readmission, mortality, skin blistering, and device-related adverse events. RESULTS: Eighty-five RCTs comprising 16 980 patients (iNPWT, n = 8463; standard dressing, n = 8517) were included. The mean (SD) age was 48.3 (19.4) years (48.1 [19.5] years in the iNPWT group and 48.5 [19.4] years in the standard dressing group), and 5660 of 16 075 individuals (35.2%) were male (2889 [35.7%] in the iNPWT group and 2771 [34.7%] in the standard dressing group). iNPWT was associated with lower risk of overall SSI (RR, 0.64; 95% CI, 0.57-0.72), deep SSI (RR, 0.66; 95% CI, 0.51-0.86), superficial SSI (RR, 0.59; 95% CI, 0.49-0.72), wound dehiscence (RR, 0.73; 95% CI, 0.61-0.88), seroma (RR, 0.77; 95% CI, 0.63-0.94), reoperation (RR, 0.80; 95% CI, 0.64-0.99), and skin necrosis (RR, 0.38; 95% CI, 0.18-0.80). No significant differences were observed for organ-space SSI, readmission, or mortality. iNPWT was associated with higher risks of skin blistering (RR, 4.51; 95% CI, 2.37-8.58) and device-related adverse events (RR, 11.87; 95% CI, 4.74-29.74). The number needed to treat was 21 for SSI; the number needed to harm was 18 for skin blistering and 11 for device-related adverse events. Trial sequential analysis confirmed evidence for overall, deep, and superficial SSI. Certainty of evidence was moderate. CONCLUSIONS AND RELEVANCE: In this systematic review and meta-analysis of 85 RCTs, iNPWT was associated with lower risks of overall, deep, and superficial SSI and several wound complications but potentially higher risks of skin blistering and device-related adverse events. These findings support selective rather than routine use, particularly in patients at elevated risk of incisional wound complications.

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