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

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.

Study Overview

• Status: Completed
• Conditions: Cesarian Scar; Surgical Site Infection (SSI)
• Intervention / Treatment: Device: Polyurethane Foam dressing(Mepilex Border Flex); Device: Conventional Gauze Dressing

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Korea
  • Sejong-si
    • Sejong, Sejong-si, South Korea, 30099
      • Sejong Chungnam National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 1. Korean women aged 18 years or older who provided written informed consent to participate in the study

  2. Patients who underwent emergency or elective cesarean section

  3. Patients with a transverse skin and uterine incision (Pfannenstiel incision)

  4. Patients who received prophylactic antibiotics (Cefazolin 1g) intravenously 30 minutes prior to surgery

  5. Patients who completed at least three follow-up visits after discharge

Exclusion Criteria:

• Patients under 18 years of age

  2. Patients who did not undergo transverse skin or uterine incision (i.e., vertical incision)

  3. Use of antibiotics prior to delivery (excluding prophylactic antibiotics administered at delivery)

  4. Patients taking immunosuppressive drugs

  5. History of adhesive allergy or allergic skin diseases

  6. Patients unable to complete the required follow-up schedule

  7. Patients who did not consent or were unable to understand the study protocol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention Group (Polyurethane Foam); 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); 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.
Experimental: control group : conventional gauze dressing; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Surgical Site Infection (SSI)	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.	During hospitalization (postoperative day 2 and day 4), 1 week post-discharge, and 1 month post-operatively

Collaborators and Investigators

• Sponsor: Yewon Jung

Publications and helpful links

General Publications

• REFERENCES[예정9.1] 1. Briones, E. M., & Cohen, R. A. (2024). Health insurance coverage: early release of estimates from the National Health Interview Survey, January-June 2024. 2. Kim HY, Lee D, Kim J, Noh E, Ahn KH, Hong SC, Oh MJ, Kim HJ, Kwon HS, Lee SM. Secular trends in cesarean sections and risk factors in South Korea (2006-2015). Obstetrics & Gynecology Science. 2020;63(4):440-447. 3. Korea Biomedical Review (2025). "Ob-gyn doctors warn Korea faces collapse of delivery care" Published: September 15, 2025. Available at: https://www.koreabiomed.com/news/articleView.html?idxno=28970 4. Küçük M. Defensive medicine among obstetricians and gynaecologists in Turkey. Journal of Obstetrics and Gynaecology. 2018;38(2):200-205. 5. Sugita, Y., Komatsu, H., Kodera, C., Urushiyama, D., Enomoto, N., Nagasaki, S., ... & Ogawa, R. (2025). Impact of abnormal cesarean section scar formation on quality of life and postpartum depression: A cross-sectional study in Japan. International Journal of Gynecology & Obstetrics. 172(2):1015-1022. 6. Obiezu, F. I., Senior, M. A., & Vardanian, A. J. (2025). Surgical Scar Management and Outcomes in Racial/Ethnic Minorities: A Systematic Review. Plastic and Reconstructive Surgery-Global Open, 13(4), e6669. 7. Xiao Ling, MD, Mingzi Zhang, MD, et al. (2016). Algorithm of chest wall Keloid treatment. Medicine, 95:35(e4684). 8. Cosker T, Elsayed S, Gupta S, Mendonca AD, Tayton KJ. (2005). Choice of dressings has a major impact on blistering and healing outcomes in orthopaedic patients. J Wound Care, 14:27-29. 9. Arroyo AA, Casanova PL, Soriano JV, Torra i Bou J-E. (2015). Open-label clinical trial comparing the clinical and economic effectiveness of using a polyurethane film surgical dressing with gauze surgical dressings in the care of post-operative surgical wounds. Int Wound J, 12:285-292. 10. Son, Daegu; Harijan, Aram. (2014). Overview of surgical scar prevention and management. Journal of Korean Medical Science, 29.6: 751. 11. Park JW, Kim YK

Helpful Links

• Sejong Chungnam National University Hospital Official Website

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Actual): June 13, 2025
• Study Completion (Actual): June 13, 2025

Study Registration Dates

• First Submitted: March 16, 2026
• First Submitted That Met QC Criteria: March 16, 2026
• First Posted (Actual): March 19, 2026

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: cesarean section; scar formation; polyurethane foam; wound dressing; PSAS; korean women
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Infections; Wound Infection; Pathological Conditions, Signs and Symptoms; Surgical Wound Infection
• Other Study ID Numbers: CSWD_RCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared due to privacy and confidentiality protections for participants, institutional data governance policies, and the sensitive nature of obstetric patient information. The study was conducted under IRB approval (No. 2024-03-004) at Sejong Chungnam National University Hospital, and data sharing was not included in the original consent process.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No