None listed
Conditions
Interventions
Medical Device : Patients will be randomized to SS-PDS experimental group and control group at a 1:1 ratio:
SS-PDS experimental group: fascia closure using barbed suture (SS-PDS)
SS-PDS control group
Sponsors
Seoul National University Bundang Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Female patients planning to undergo elective midline laparotomy for gynecological diseases. 2. Over 18 years old. 3. ECOG performance status 0 - 2
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year cumulative incidence of incisional hernia | — |
Secondary
| Measure | Time frame |
|---|---|
| safety (Comparison of prevalence and grade of adverse events between SS-PDS experimental group and control group.) | — |
Countries
Korea, Republic of
Contacts
Public Contactkidong kim
Seoul National University Bundang Hospital
Outcome results
None listed