Subcutaneous Suture Versus no Subcutaneous Suture for Abdominal Wound Closure
Surgical site infections are among the most frequent complications after abdominal surgery and are associated with impaired wound healing, prolonged hospital stay, additional treatments, and increased healthcare costs. Closure of the subcutaneous tissue before skin closure is commonly performed in abdominal surgery, bu
| Condition(s) | Surgical Site Infection (SSI), Wound Healing Complication |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | Surgical site infections are among the most frequent complications after abdominal surgery and are associated with impaired wound healing, prolonged hospital stay, additional treatments, and increased healthcare costs. Closure of the subcutaneous tissue before skin closure is commonly performed in abdominal surgery, but the available evidence supporting this practice remains limited and heterogeneous, particularly outside caesarean section surgery. The SUTURE trial is a prospective, randomized, patient- and assessor-blinded superiority trial evaluating whether subcutaneous tissue closure reduces the incidence of surgical site infections after abdominal surgery. Adult patients undergoing elective open or laparoscopically/robotically assisted abdominal surgery with an abdominal incision of a |
| Who can participate | Inclusion Criteria: * Adult patients (≥18 years) * elective laparotomy (midline laparotomy, transverse laparotomy, subcostal incision, thoracoabdominal incision, or extended Pfannenstiel incision) or laparoscopically assisted abdominal surgery with a specimen extraction incision of at least 6 cm. Exclusion Criteria: * Emergency laparotomy. * Anticipated or documented non-compliance with study procedures or follow-up. * Patients in whom primary wound closure cannot be achieved at the end of surgery. * Patients unable to provide informed consent. |
| Ages | 18 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | University Hospital Augsburg |
| Locations | Augsburg, Bavaria, Germany |
| Start date | 2026-03-23 |
| NCT ID | NCT07615517 |
| Official listing | https://clinicaltrials.gov/study/NCT07615517 |