Cesarian ScarCSWD_RCTNCT07482202

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

A study testing Polyurethane Foam dressing(Mepilex Border Flex) and Conventional Gauze Dressing in people with Cesarian Scar and Surgical Site Infection (SSI), run by Yewon Jung at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Background: Cesarean delivery is one of the most frequently performed surgical procedures worldwide, and postoperative scar quality remains an important patient-centered outcome. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Cesarian Scar, Surgical Site Infection (SSI)
What is being tested?: Polyurethane Foam dressing(Mepilex Border Flex) and Conventional Gauze Dressing
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 200 participants
Where: 1 siteSouth Korea
Study dates: 1 May 2024to 13 Jun 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Sejong Chungnam National University Hospital
Sejong, Sejong-si, 30099

Other trials in South Korea

About this study

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)
Being tested: Polyurethane Foam dressing(Mepilex Border Flex), Conventional Gauze Dressing
Keywords: cesarean section, wound dressing, polyurethane foam, scar formation, PSAS, korean women
Medical subject headings: Surgical Wound Infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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 DressingDevice
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.

Study groups in NCT07482202
Study group	Role	What they receive
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 Receives: 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 Receives: Device: Conventional Gauze Dressing

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 1 week post-discharge, 1 month post-operatively, and 6 months post-operatively

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 202413 Jun 2025

First posted19 Mar 2026
Study start1 May 2024
Primary completion13 Jun 2025
Study completion13 Jun 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Cesarian ScarStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07482202
Sponsor's protocol ID: CSWD_RCT
Acronym: CSWD_RCT
Status last verified: Feb 2026
First submitted: 16 Mar 2026
Last updated: 19 Mar 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: 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.

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

Study at a glance

From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Polyurethane Foam Versus Gauze Dressing After Cesarean Delivery in a Standardized Surgical Setting: A Prospective Randomized Controlled Trial
ClinicalTrials.gov ID: NCT07482202
Acronym / sponsor ID: CSWD_RCT / CSWD_RCT
Conditions: Cesarian Scar, Surgical Site Infection (SSI)
Keywords: cesarean section, wound dressing, polyurethane foam, scar formation, PSAS, korean women
Study type: Interventional
Recruitment status: Completed
Enrolment: 200 participants (actual)
Lead sponsor: Yewon JungUniversity, hospital or other
Study start: 1 May 2024 (actual)
Primary completion: 13 Jun 2025 (actual)
Study completion: 13 Jun 2025 (actual)
First posted: 19 Mar 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Background:

Methods:

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Intervention Group (Polyurethane Foam)	Active comparator	Device: Polyurethane Foam dressing(Mepilex Border Flex)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
control group : conventional gauze dressing	Experimental	Device: Conventional Gauze DressingAll 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

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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	Intervention Group (Polyurethane Foam)
Conventional Gauze DressingImmediately 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.	Device	control group : conventional gauze dressing

Primary outcome

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.

1 secondary outcome

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
Results publicationREFERENCES[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
Sejong Chungnam National University Hospital Official WebsiteLink provided by the sponsor.
Individual participant dataSharing planned: No. 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Scar Cosmesis assessed by Patient Scar Assessment Scale (PSAS) (time frame: 1 week post-discharge, 1 month post-operatively, and 6 months post-operatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07482202, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.