Subcutaneous Suture Versus no Subcutaneous Suture for Abdominal Wound Closure

NCT07615517 | Recruiting

• 2 other identifiers: 25-1085DRKS00039310
• Study Type: interventional
• Target: 655
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• SSI grade I or II according to CDC criteria within 30 days after surgery.

  Occurrence of superficial or deep surgical site infection (SSI grade I or II according to CDC criteria) within 30 days after surgery, expressed as number and percentage of affected patients.

  30 days after surgery

Study Arms (2)

No subcutaneous suture

NO INTERVENTION

After standardized fascial closure according to institutional standards, patients are randomized: Control group (no subcutaneous suture group) After fascial closure, no suturing of the subcutaneous tissue is performed. Skin closure is identical to the intervention group: in open laparotomy using skin staples in laparoscopically assisted procedures using a continuous intracutaneous suture (Monocryl® 3-0)

with subcutaneous suture

EXPERIMENTAL

After standardized fascial closure according to institutional standards, 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)

Procedure: subcutaneous suture

Interventions

subcutaneous suture PROCEDURE

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)

with subcutaneous suture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital Augsburg: lead

Study Sites (1)

University Hospital Augsburg

Augsburg, Bavaria, Germany

RECRUITING

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Johannes Lauscher, Prof. Dr. med.

  Klinik für Allgemein-, Viszeral-, Transplantations- und Thoraxchirurgie

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Florian Schepp, Dr. med.

CONTACT

+490821400168803; florian.schepp@uk-augsburg.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: May 29, 2026
• Study Start: March 23, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): May 30, 2028
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)