Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID07615517

Subcutaneous Suture Versus No Subcutaneous Suture for Abdominal Wound Closure in Abdominal Surgery

Led by University Hospital Augsburg · Updated on 2026-05-29

655

Participants Needed

1

Research Sites

12 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Surgical site infections (SSI) are common and serious complications following abdominal surgery, leading to delayed healing, longer hospital stays, additional treatments, and higher healthcare costs. Closure of the subcutaneous tissue before skin closure is a standard practice, but clear evidence about its benefits outside of caesarean sections is limited. This trial aims to provide high-quality evidence on whether subcutaneous tissue closure reduces SSI after abdominal surgery. Adult patients undergoing elective open or laparoscopically/robotically assisted abdominal surgery with an incision of at least 6 cm are randomly assigned during surgery to either have the subcutaneous tissue closed with interrupted Vicryl 2-0 sutures or no subcutaneous tissue closure before skin closure. Skin closure is done with staples for open surgery and continuous intracutaneous Monocryl 3-0 sutures for minimally invasive procedures. The study compares these two approaches to assess their impact on infection rates. Participants will be monitored during their hospital stay and at a 30-day follow-up visit, with wound assessments performed by blinded evaluators. Researchers will track the occurrence of surgical site infections within 30 days, as well as wound healing time, antibiotic use, wound complications, need for reoperation, patient scar assessments, quality of life, and healthcare resource use. The total involvement includes surgery, inpatient assessments, and follow-up to evaluate outcomes and safety.

CONDITIONS

Brief Title

Subcutaneous Suture Versus no Subcutaneous Suture for Abdominal Wound Closure

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients 18 years or older
  • Scheduled for elective laparotomy or laparoscopically assisted abdominal surgery
  • Abdominal incision of at least 6 cm
Not Eligible

You will not qualify if you...

  • Emergency laparotomy
  • Anticipated or documented inability to comply with study procedures or follow-up
  • Patients unable to achieve primary wound closure at surgery end
  • Unable to provide informed consent

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Day of surgery

Participants undergo elective abdominal surgery where they are randomized intraoperatively to receive either subcutaneous tissue closure or no subcutaneous tissue closure before skin closure.

1 visit (in-person, surgery day)

Post-operative Follow-up

Duration - 30 days after surgery

Participants have post-operative wound assessments during their inpatient stay and at a predefined 30-day follow-up visit to monitor wound healing and surgical site infections.

Inpatient assessments plus 1 follow-up visit at 30 days

Trial Site Locations

Total: 1 location

1

University Hospital Augsburg

Augsburg, Bavaria, Germany

Actively Recruiting

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Research Team

F

Florian Schepp, Dr. med.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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