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Subcutaneous Suture Versus no Subcutaneous Suture for Abdominal Wound Closure

NCT07615517 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 655

Last updated 2026-05-29

No results posted yet for this study

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.

Conditions

  • Surgical Site Infection (SSI)
  • Wound Healing Complication

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)

Sponsors & Collaborators

  • University Hospital Augsburg

    lead OTHER

Principal Investigators

  • Johannes Lauscher, Prof. Dr. med. · Klinik für Allgemein-, Viszeral-, Transplantations- und Thoraxchirurgie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-23
Primary Completion
2028-03-01
Completion
2028-05-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07615517 on ClinicalTrials.gov