Ignite Creation Date:
2025-12-24 @ 9:55 PM
Ignite Modification Date:
2025-12-25 @ 11:40 PM
Study NCT ID:
NCT03536832
Status:
COMPLETED
Last Update Posted:
2018-11-16
First Post:
2018-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Subcuticular Skin Closure at Cesarean Delivery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002585', 'term': 'Cesarean Section'}, {'id': 'D011098', 'term': 'Polyglactin 910'}], 'ancestors': [{'id': 'D036861', 'term': 'Delivery, Obstetric'}, {'id': 'D013513', 'term': 'Obstetric Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D011091', 'term': 'Polyesters'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-14', 'studyFirstSubmitDate': '2018-05-09', 'studyFirstSubmitQcDate': '2018-05-23', 'lastUpdatePostDateStruct': {'date': '2018-11-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'surgical site infection', 'timeFrame': '1 week', 'description': 'infection'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cesarean Section; Complications', 'suture material'], 'conditions': ['Cesarean Section; Infection']}, 'descriptionModule': {'briefSummary': 'Subcuticular skin closure with suture after cesarean has been shown to result in lower rates of wound complications than with staple closure. However, the optimal choice of suture material for subcuticular skin closure is unclear. Vicryl vs Prolen suture materials will be used for subcuticular closure of transverse skin incisions after cesarean section. Patients will be controlled for superficial surgical site infections 1 week after the cesarean section.', 'detailedDescription': 'Cesarean section is the most common abdominal surgery worldwide. Subcuticular skin closure with suture after cesarean has been shown to result in lower rates of wound complications than with staple closure. However, the optimal choice of suture material for subcuticular skin closure is unclear. Vicryl vs Prolen suture materials will be used for subcuticular closure of transverse skin incisions after cesarean section. Patients will be controlled for superficial surgical site infections 1 week after the cesarean section.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-40\n* women undergoing cesarean section\n\nExclusion Criteria:\n\n* body mass index\\>30'}, 'identificationModule': {'nctId': 'NCT03536832', 'briefTitle': 'Subcuticular Skin Closure at Cesarean Delivery', 'organization': {'class': 'OTHER', 'fullName': 'Kanuni Sultan Suleyman Training and Research Hospital'}, 'officialTitle': 'Comparison of Suture Materials for Subcuticular Skin Closure at Cesarean Delivery', 'orgStudyIdInfo': {'id': '2018.4.20'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'cesarean section with Vicryl', 'description': 'Women undergoing cesarean section with low transverse skin incisions will be closed with 3-0 Vicryl.', 'interventionNames': ['Procedure: Cesarean Section with Vicryl']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'cesarean section with prolene', 'description': 'Women undergoing cesarean section with low transverse skin incisions will be closed with 3-0 Prolen.', 'interventionNames': ['Procedure: Cesarean Section with Prolen']}], 'interventions': [{'name': 'Cesarean Section with Vicryl', 'type': 'PROCEDURE', 'description': 'Pfnannenstiel incision will be done under general or spinal anaesthesia. The abdomen will be opened and fetus and plasenta will be delivered. Then abdomen will be closed. Skin will be closed with Vicryl.', 'armGroupLabels': ['cesarean section with Vicryl']}, {'name': 'Cesarean Section with Prolen', 'type': 'PROCEDURE', 'description': 'Pfnannenstiel incision will be done under general or spinal anaesthesia. The abdomen will be opened and fetus and plasenta will be delivered. Then abdomen will be closed. Skin will be closed with prolen.', 'armGroupLabels': ['cesarean section with prolene']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Kanuni SSTRH', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Berna Aslan A Çetin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'KSSTRH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kanuni Sultan Suleyman Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Md, ObGYN', 'investigatorFullName': 'Berna Aslan Cetin', 'investigatorAffiliation': 'Kanuni Sultan Suleyman Training and Research Hospital'}}}}