Prevention of postoperative complications with negative pressure wound therapy after complex breast cancer surgery: a study protocol of a randomised controlled trial (TPN-SEIN)

BACKGROUND: Complex breast surgery, including immediate breast reconstruction and oncoplastic procedures, is increasingly performed to optimise oncologic and aesthetic outcomes. Postoperative wound healing complications remain a major concern, particularly in high-risk patients. Negative pressure wound therapy (NPWT) has been shown to improve wound healing in various surgical fields. However, its effectiveness in oncologic breast surgery remains insufficiently studied. This study aims to evaluate the efficacy of NPWT in reducing wound healing complications in complex breast cancer surgery. METHODS: The TPN-SEIN study is a prospective, randomised, controlled, open-label, multicentre, phase III clinical trial. A total of 254 patients undergoing complex breast cancer surgery will be randomised either to arm 1 (NPWT immediately postoperatively for 7 days) or arm 2 (standard wound care). The primary endpoint is the rate of wound healing complications at day 30, defined as at least one of the following: deep postoperative infection of the prosthetic pocket, wound dehiscence or incomplete healing. Secondary endpoints include surgical site infection at day 90, reoperation rate, hospital readmission rate, time to complete healing, time to adjuvant treatment initiation, quality of life (European Organisation for Research and Treatment of Cancer Core Quality of Life questionnaire and breast cancer-specific quality of life questionnaire (QLQ-C30)), patient satisfaction and medico-economic outcomes. ETHICS AND DISSEMINATION: The study was approved by the French national ethics committee (Comité de Protection des Personnes Est II, 5 December 2024, reference 24.04416.000295) and the institutional review board (IRB-COMERE, reference ICM-RCM 2024/11). The French National Agency for the Safety of Health Products has been notified. The study results will be presented at both national and international conferences and will also be published in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT06265558.