Clinical Trial

Subcutaneous Suture Versus no Subcutaneous Suture for Abdominal Wound Closure

Study acronym: SUTURE
Recruiting
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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 at least 6 cm will be randomized intraoperatively after fascial closure to either subcutaneous tissue closure using interrupted Vicryl® 2-0 sutures or no subcutaneous tissue closure. The primary endpoint is the occurrence of surgical site infection according to CDC criteria grade I-II within 30 days after surgery. The trial aims to provide high-quality evidence on whether routine subcutaneous tissue closure should be recommended as a standardized wound closure strategy in abdominal surgery.
Trial Details
NCT Number NCT07615517
Lead Sponsor University Hospital Augsburg
Conditions Surgical Site Infection (SSI), Wound Healing Complication
Enrollment 655 participants
Start Date 2026-03-23
Primary Completion 2028-03-01 (estimated)
Study Completion 2028-05-30 (estimated)
Updated on ClinicalTrials.gov 2026-05-29