Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 9:17 PM
Study NCT ID:
NCT07482202
Status:
COMPLETED
Last Update Posted:
2026-03-19
First Post:
2026-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Polyurethane Foam Versus Gauze Dressing After Cesarean Delivery in a Standardized Surgical Setting: A Prospective Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013530', 'term': 'Surgical Wound Infection'}], 'ancestors': [{'id': 'D014946', 'term': 'Wound Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2004-03-15', 'size': 251170, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2026-02-26T21:16', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2025-06-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-16', 'studyFirstSubmitDate': '2026-03-16', 'studyFirstSubmitQcDate': '2026-03-16', 'lastUpdatePostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Scar Cosmesis assessed by Patient Scar Assessment Scale (PSAS)', 'timeFrame': '1 week post-discharge, 1 month post-operatively, and 6 months post-operatively', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Incidence of Surgical Site Infection (SSI)', 'timeFrame': 'During hospitalization (postoperative day 2 and day 4), 1 week post-discharge, and 1 month post-operatively', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cesarean section', 'wound dressing', 'polyurethane foam', 'scar formation', 'PSAS', 'korean women'], 'conditions': ['Cesarian Scar', 'Surgical Site Infection (SSI)']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': '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'}], 'seeAlsoLinks': [{'url': 'https://www.cnush.co.kr/main/index.do', 'label': 'Sejong Chungnam National University Hospital Official Website'}]}, 'descriptionModule': {'briefSummary': 'Background:\n\nCesarean 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.\n\nMethods:\n\nIn 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.\n\nAlthough 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Korean women aged 18 years or older who provided written informed consent to participate in the study\n\n 2\\. Patients who underwent emergency or elective cesarean section\n\n 3\\. Patients with a transverse skin and uterine incision (Pfannenstiel incision)\n\n 4\\. Patients who received prophylactic antibiotics (Cefazolin 1g) intravenously 30 minutes prior to surgery\n\n 5\\. Patients who completed at least three follow-up visits after discharge\n\nExclusion Criteria:\n\n* Patients under 18 years of age\n\n 2\\. Patients who did not undergo transverse skin or uterine incision (i.e., vertical incision)\n\n 3\\. Use of antibiotics prior to delivery (excluding prophylactic antibiotics administered at delivery)\n\n 4\\. Patients taking immunosuppressive drugs\n\n 5\\. History of adhesive allergy or allergic skin diseases\n\n 6\\. Patients unable to complete the required follow-up schedule\n\n 7\\. Patients who did not consent or were unable to understand the study protocol'}, 'identificationModule': {'nctId': 'NCT07482202', 'acronym': 'CSWD_RCT', 'briefTitle': 'Polyurethane Foam Versus Gauze Dressing After Cesarean Delivery in a Standardized Surgical Setting: A Prospective Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Chungnam National University Sejong Hospital'}, 'officialTitle': 'Polyurethane Foam Versus Gauze Dressing After Cesarean Delivery in a Standardized Surgical Setting: A Prospective Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'CSWD_RCT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention Group (Polyurethane Foam)', 'description': '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.\n\nPatients were randomized into two groups:\n\nIntervention 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', 'interventionNames': ['Device: Polyurethane Foam dressing(Mepilex Border Flex)']}, {'type': 'EXPERIMENTAL', 'label': 'control group : conventional gauze dressing', 'description': '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.\n\nPatients were randomized into two groups:\n\nControl 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', 'interventionNames': ['Device: Conventional Gauze Dressing']}], 'interventions': [{'name': 'Polyurethane Foam dressing(Mepilex Border Flex)', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Intervention Group (Polyurethane Foam)']}, {'name': 'Conventional Gauze Dressing', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['control group : conventional gauze dressing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30099', 'city': 'Sejong', 'state': 'Sejong-si', 'country': 'South Korea', 'facility': 'Sejong Chungnam National University Hospital', 'geoPoint': {'lat': 36.59245, 'lon': 127.29223}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yewon Jung', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Obstetrics and Gynecology', 'investigatorFullName': 'Yewon Jung', 'investigatorAffiliation': 'Chungnam National University Sejong Hospital'}}}}