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Completed

NCT Number: NCT07482202

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

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.

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Key information

Conditions

Cesarian Scar Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Site Infection (SSI) Surgical Wound Infection Wound Infection

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sejong Chungnam National University Hospital

Sejong, Sejong-si, 30099, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1. 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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. Scar Cosmesis assessed by Patient Scar Assessment Scale (PSAS)

    Time frame: 1 week post-discharge, 1 month post-operatively, and 6 months post-operatively

    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.

Secondary outcomes

  1. Incidence of Surgical Site Infection (SSI)

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

    Surgical site infection was assessed by clinical inspection for signs including redness, edema, pain, heat, pustules, discharge, fever, or odor. SSI was classified as superficial or deep, and the need for antibiotic therapy was recorded.

Sponsors and collaborators

Lead sponsor

Yewon Jung

Other

Registry information

Acronym: CSWD_RCT

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 19, 2026
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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