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RECRUITING
NCT07615517
NA

Subcutaneous Suture Versus no Subcutaneous Suture for Abdominal Wound Closure

Sponsor: University Hospital Augsburg

View on ClinicalTrials.gov

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.

Official title: Subcutaneous Suture Versus no Subcutaneous Suture for Abdominal Wound Closure in Abdominal Surgery

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

655

Start Date

2026-03-23

Completion Date

2028-05-30

Last Updated

2026-05-29

Healthy Volunteers

Yes

Interventions

PROCEDURE

subcutaneous suture

After standardized fascial closure according to institutional standards and subcutaneous irrigation with polyhexanide (Serasept®), patients are randomized to one of the following treatment groups: Intervention group (subcutaneous suture group) Following fascial closure, the subcutaneous adipose tissue is approximated with interrupted absorbable sutures (Vicryl® 2-0).a Skin closure is performed: in open laparotomy using skin staples in laparoscopically assisted procedures using a continuous intracutaneous suture (Monocryl® 3-0)

Locations (1)

University Hospital Augsburg

Augsburg, Bavaria, Germany