NCT02838017

Tissue Adhesive vs. Sterile Strips After Cesarean Delivery

Tissue Adhesive Compared to Sterile Strips After Cesarean Delivery: A Randomized Controlled Trial

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 504 (actual)
• Sponsor: Endeavor Health · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

Summary

The goal of this project is to identify a strategy to reduce wound complications in women who undergo cesarean delivery by Pfannenstiel skin incision. Currently, many Pfannenstiel skin incisions are closed by subcuticular sutures followed by either placement of sterile strips or tissue A\\adhesive. Either sterile strips or tissue adhesive can be placed over the wound as a covering but it is unclear which may reduce wound complication rates. The hypothesis of this study is that tissue adhesive will result in a reduction in wound complication rates when compared to sterile strips. Previously published studies in non-obstetric populations have identified tissue adhesive as a potential intervention to reduce wound complications. The eligible population for this study will include women at NorthShore University HealthSystem Evanston Hospital and University of Chicago Hospital who will undergo primary or repeat cesarean delivery via Pfannenstiel skin incision. Women in the study will be randomized to receive either sterile strips or tissue adhesive. The primary outcome to be evaluated will be a composite of wound complication which will include drainage, cellulitis, hematoma, seroma and/or wound separation (partial or complete). Secondary endpoints to be investigated include cosmetic outcome, patient satisfaction, cost comparison, and difference in operative times.

Conditions

• Wound Complication
• Complications; Cesarean Section

Interventions

Type	Name	Description
DEVICE	Tissue Adhesive
DEVICE	Sterile strips

Timeline

• Start date: 2016-11-01
• Primary completion: 2018-06-01
• Completion: 2018-06-01
• First posted: 2016-07-20
• Last updated: 2019-08-14
• Results posted: 2019-08-14

Locations

3 sites across 1 country: United States