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

NCT07482202 | Completed

• 1 other identifier: CSWD_RCT
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

cesarean section; wound dressing; polyurethane foam; scar formation; PSAS; korean women

Outcome Measures

Primary Outcomes (1)

• Scar Cosmesis assessed by Patient Scar Assessment Scale (PSAS)

  Scar cosmesis was evaluated using the Patient Scar Assessment Scale (PSAS), a validated patient-reported outcome measure. The PSAS assesses six subjective scar characteristics: pain, itching, color difference, stiffness, thickness, and irregularity. Each item is scored on a numerical scale from 1 (normal/no symptoms) to 10 (worst imaginable/most different from normal skin), yielding a total score ranging from 6 to 60. A lower score indicates better scar cosmesis.

  1 week post-discharge, 1 month post-operatively, and 6 months post-operatively

Secondary Outcomes (1)

• Incidence of Surgical Site Infection (SSI)

  During hospitalization (postoperative day 2 and day 4), 1 week post-discharge, and 1 month post-operatively

Study Arms (2)

Intervention Group (Polyurethane Foam)

ACTIVE COMPARATOR

All participants underwent cesarean section performed by a single surgeon to eliminate inter-operator variability. A Pfannenstiel incision, a standardized technique with 4-0 rapid vicryl for subcuticular suture. As absorbable sutures were used, Perioperative antibiotic prophylaxis followed institutional protocol. Patients were randomized into two groups: Intervention Group (Polyurethane Foam): Immediately after surgery, the wound was a Mepilex Border Flex dressing was applied. outcome mesure is PSAS and SSI. Follow-up assessments were conducted at three predefined time points: 1 week post-discharge (Visit #1), 1 month postoperatively (Visit #2), and 6 months postoperatively

Device: Polyurethane Foam dressing(Mepilex Border Flex)

control group : conventional gauze dressing

EXPERIMENTAL

All participants underwent cesarean section performed by a single surgeon to eliminate inter-operator variability. A Pfannenstiel incision, a standardized technique with 4-0 rapid vicryl for subcuticular suture. As absorbable sutures were used, Perioperative antibiotic prophylaxis followed institutional protocol. Patients were randomized into two groups: Control group (conventional gauze dressing): Immediately after surgery, the wound was a conventional gauze dressing was applied. outcome mesure is PSAS and SSI. Follow-up assessments were conducted at three predefined time points: 1 week post-discharge (Visit #1), 1 month postoperatively (Visit #2), and 6 months postoperatively

Device: Conventional Gauze Dressing

Interventions

Polyurethane Foam dressing(Mepilex Border Flex) DEVICE

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.

Intervention Group (Polyurethane Foam)

Conventional Gauze Dressing DEVICE

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.

control group : conventional gauze dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Korean women aged 18 years or older who provided written informed consent to participate in the study
• \. Patients who underwent emergency or elective cesarean section
• \. Patients with a transverse skin and uterine incision (Pfannenstiel incision)
• \. Patients who received prophylactic antibiotics (Cefazolin 1g) intravenously 30 minutes prior to surgery
• \. Patients who completed at least three follow-up visits after discharge

You may not qualify if:

• Patients under 18 years of age
• \. Patients who did not undergo transverse skin or uterine incision (i.e., vertical incision)
• \. Use of antibiotics prior to delivery (excluding prophylactic antibiotics administered at delivery)
• \. Patients taking immunosuppressive drugs
• \. History of adhesive allergy or allergic skin diseases
• \. Patients unable to complete the required follow-up schedule
• \. Patients who did not consent or were unable to understand the study protocol

Sponsors & Collaborators

• Yewon Jung: lead

Study Sites (1)

Sejong Chungnam National University Hospital

Sejong, Sejong-si, 30099, South Korea

Location

Related Publications (1)

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  RESULT

Related Links

• Sejong Chungnam National University Hospital Official Website

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Obstetrics and Gynecology

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 19, 2026
• Study Start: May 1, 2024
• Primary Completion: June 13, 2025
• Study Completion: June 13, 2025
• Last Updated: March 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)