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

NCT07482202 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-03-19

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Yewon Jung

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-01
Primary Completion
2025-06-13
Completion
2025-06-13

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07482202 on ClinicalTrials.gov