Effect of Barbed Suture Fascia Closure on Incisional hernia in Midline Laparotomy for Gynecological Diseases (BARBHER)
- Conditions
- Diseases of the genitourinary system
- Registration Number
- KCT0005156
- Lead Sponsor
- Seoul National University Bundang Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 174
1. Female patients planning to undergo elective midline laparotomy for gynecological diseases.
2. Over 18 years old.
3. ECOG performance status 0 - 2
1. Patients with previous or present abdominal incisional hernia.
2. Pregnant patients.
3. Patients receiving external radiation treatment to the pelvis or abdomen.
4. Patients allergic to PDS components.
5. Patient with diseases that affect wound healing including uncontrolled diabetes, autoimmune vasculitis, and hepatocirrhosis.
6. BMI>35
7. Patients are excluded if they have used or are expected to use drugs that may affect wound healing such as bevacizumab. In case where bevacizumab is used, participation is possible if they have a four-week washout period before and after surgery, respectively.
8. Patients who have had an abdominal midline laparotomy for the last 6 months.
9. If patients had surgery for suspected infection.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1-year cumulative incidence of incisional hernia
- Secondary Outcome Measures
Name Time Method safety (Comparison of prevalence and grade of adverse events between SS-PDS experimental group and control group.)