NCT07482202

Polyurethane Foam Versus Gauze Dressing After Cesarean Delivery in a Standardized Surgical Setting: A Prospective Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Yewon Jung · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Background: Cesarean delivery is one of the most frequently performed surgical procedures worldwide, and postoperative scar quality remains an important patient-centered outcome. Advanced dressings such as polyurethane foam are increasingly used to optimize the wound environment; however, evidence supporting their superiority over conventional gauze remains limited. This study aimed to compare the effects of polyurethane foam and gauze dressings on scar outcomes and surgical site infection (SSI) following cesarean delivery. Methods: In this prospective, single-blind randomized controlled trial conducted between 2024 and 2025, women undergoing cesarean delivery via Pfannenstiel incision were randomly assigned to receive either polyurethane foam or conventional gauze dressing. All procedures were performed by a single surgeon using a standardized 4-0 rapid Vicryl subcuticular closure technique. Scar outcomes were assessed using the Patient Scar Assessment Scale (PSAS) at 1 week, 1 month, and 6 months postoperatively. The incidence of 30-day SSI was also evaluated. Although there have been significant advancements in wound dressing materials and techniques, with numerous types of dressings now available, there has been a paucity of studies investigating the efficacy and scar outcomes of these modern dressings specifically in cesarean section, which is classified as a clean wound in obstetric and gynecological surgery. The present study, by incorporating patient scar satisfaction as an outcome measure, will serve as a valuable contribution to evaluating the clinical significance of contemporary wound dressings in this surgical context.

Conditions

• Cesarian Scar
• Surgical Site Infection (SSI)

Interventions

Type	Name	Description
DEVICE	Polyurethane Foam dressing(Mepilex Border Flex)	Immediately after cesarean section, the wound was cleaned with alcohol and a Mepilex Border Flex polyurethane foam dressing was applied. On postoperative day 2, the wound was inspected; if no complications were found, a new Mepilex Border Flex dressing was applied. The wound was reassessed on postoperative day 4 prior to hospital discharge.
DEVICE	Conventional Gauze Dressing	Immediately after cesarean section, the wound was cleaned with alcohol and covered with a conventional sterile gauze dressing. On postoperative day 2, the gauze was removed for wound inspection and replaced with a new gauze dressing if the wound was clean. Patients were discharged on postoperative day 4.

Timeline

• Start date: 2024-05-01
• Primary completion: 2025-06-13
• Completion: 2025-06-13
• First posted: 2026-03-19
• Last updated: 2026-03-19

Locations

1 site across 1 country: South Korea