Incisional Negative Pressure Wound Therapy After Revascularisation Surgery in Patients with Peripheral Arterial Disease: A Randomised Trial (PICO-Vasc Study).

ABSTRACT

OBJECTIVE: This study assessed the potential benefits of using incisional negative pressure wound therapy (iNPWT) for patients undergoing revascularisation due to peripheral arterial disease. METHODS: A prospective randomised controlled trial was conducted to compare the inguinal application of iNPWT vs. standard surgical dressings. Patients were enrolled from February 2021 to November 2022. A total of 133 groin incisions were randomised (66 intervention group, 67 control group). The randomisation sequence was carried out by permuted blocks and allocation assigned by opening opaque envelopes once the revascularisation procedure had finished. Wound healing and complication rates were assessed at post-operative days 5, 14, and 30. Primary and secondary endpoints were 30 day post-operative surgical site infection (SSI) and surgical site occurrence (SSO) rates, defined as a surgical wound complication other than a SSI. Post-operative SSI was defined according to the US Centers for Disease Control and Prevention criteria. SSO included wound dehiscence, seroma or lymphocele, haematoma, and lymphorrhagia. The study was registered at ClinicalTrials.gov database (NCT04840576) and reported according to the CONSORT guidelines. RESULTS: iNPWT did not modify the 30 day inguinal SSI and SSO rates (16.7% vs. 20.9% and 37.9% vs. 44.8%; p = .53, relative risk [RR] 0.999, 95% confidence interval [CI] 0.52 - 1.88 and p = .42, RR 1.29, 95% CI 0.89 - 1.86, respectively). It reduced the early SSO rate (19.7% vs. 35.8%; p = .044, RR 1.45, 95% CI 1.047 - 2.013) and post-operative seroma rate (4.6% vs. 19.4%; p = .014, RR 1.73, 95% CI 1.296 - 2.397). CONCLUSION: There were no differences in SSI and SSO rates, although statistically significant reductions in early SSO rates and seroma were found in the intervention group.