ArticleBMJ open2026
Prevention of postoperative complications with negative pressure wound therapy after complex breast cancer surgery: a study protocol of a randomised controlled trial (TPN-SEIN).
Article in BMJ open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06265558 (Prevention of Postoperative Complications by Negative Pressure Therapy After Complex Breast Cancer Surgery), which is not on this map. Cited by 1 paper.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Prevention of Postoperative Complications by Negative Pressure Therapy After Complex Breast Cancer Surgery: a Prospective Randomized Controlled Trial
Who cites it
1 citing paper in PubMed.
- Preventing Early Complications Following Oncologic Breast Surgery: The NDoCaSco Score for Targeted Negative-Pressure Wound Dressing.Journal of personalized medicine · 2026Article
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Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundComplex 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.
methodsThe 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.
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