Actively Recruiting
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
Eligibility Criteria
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
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
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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)
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
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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