18 iNPWT <i>versus</i> standard dressing on groin surgical incisions after revascularization surgery: PICO-vasc randomised trial

Abstract Objective This study assessed the potential benefit of applying incisional negative pressure wound therapy (iNPWT) in patients undergoing revascularisation due to peripheral arterial disease. Design A prospective, randomised, controlled trial was conducted comparing the inguinal application of iNPWT versus standard surgical dressing. Patients were enrolled from February, 2021 to November, 2022. Methods One hundred and thirty-three groin incisions were randomised (66 intervention group, 67 control group). Randomisation sequence was carried out by permuted blocks and allocation assigned by opening opaque envelopes once the revascularisation procedure finished. Wound healing and complication rates were assessed at postoperative days 5, 14 and 30. The primary and secondary endpoints were: 30-day postoperative surgical site infection (SSI) and surgical site occurrence (SSO) rates, defined as surgical wound complication other than SSI. Postoperative SSI was defined according to the Center for Disease Control and Prevention (CDC) criteria. SSO included: wound dehiscence, seroma or lymphocele, haematoma, and lymphorrhagia. The study was registered at ClinicalTrails.gov database (NCT04840576) and reported according to the CONSORT guidelines. Results iNPWT did not alter the 30-day inguinal SSI and SSO rates (16.7% versus 20.9%, P = 0.53 and 37.9% versus 44.8%, P = 0.42, respectively). The use of iNPWT showed a reduction in early-SSO rate (19.7% versus 35.8%, RR 1.45, 95% c.i. 1.047–2.013), wound dehiscence (0% versus 6%, P = 0.044) and postoperative seroma (4.6% versus 19.4%, P = 0.014). Conclusion Inguinal postoperative use of iNPWT proved to be an effective preventive tool, with significant reductions in early-SSO rate, wound dehiscence, seroma, but did not alter the 30-day SSI and SSO rates.