Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2026-01-07 @ 12:48 AM
Study NCT ID:
NCT05330650
Status:
COMPLETED
Last Update Posted:
2022-04-15
First Post:
2022-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Triclosan Coated Suture in Obstetrical Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D013530', 'term': 'Surgical Wound Infection'}], 'ancestors': [{'id': 'D014946', 'term': 'Wound Infection'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011098', 'term': 'Polyglactin 910'}], 'ancestors': [{'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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 318}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-08', 'studyFirstSubmitDate': '2022-03-21', 'studyFirstSubmitQcDate': '2022-04-08', 'lastUpdatePostDateStruct': {'date': '2022-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of surgical site infection', 'timeFrame': '30 days'}], 'secondaryOutcomes': [{'measure': 'Health care costs attributable to surgical site infection', 'timeFrame': '30 days', 'description': 'Evaluation of health care costs from Hospital perspective (USD)'}, {'measure': 'Wound healing time', 'timeFrame': '30 days', 'description': 'Evaluation of healing time (days)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Surgical Site Infections', 'caesarean section', 'healthcare costs'], 'conditions': ['Cesarean Section; Infection']}, 'referencesModule': {'references': [{'pmid': '36520813', 'type': 'DERIVED', 'citation': 'Mbarki W, Bettaieb H, Souayeh N, Laabidi I, Rouis H, Halouani S, Boufarghine R, Bouyahia M, Bouhmida R, Ouederni M, Ben Amor A, Chermiti A, Laamiri H, Lika A, Chaibi I, Oueslati H, Hsayaoui N, Mbarki C. Evaluation of Triclosan coated suture in obstetrical surgery: A prospective randomized controlled study (NCT05330650). PLoS One. 2022 Dec 15;17(12):e0278939. doi: 10.1371/journal.pone.0278939. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': 'A prospective comparative randomized blinded study conducted in the obstetrics gynecology department of Ben Arous hospital over an eight-month period between November 2020 and June 2021.\n\nThe aim of this study is to evaluate effectiveness of Triclosan coated suture use in obstetrical surgery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women with indicated cesarean delivery and who have signed a written consent.\n\nExclusion Criteria:\n\n* Cases with incomplete follow up\n* Breach of operative protocol'}, 'identificationModule': {'nctId': 'NCT05330650', 'briefTitle': 'Evaluation of Triclosan Coated Suture in Obstetrical Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Tunis University'}, 'officialTitle': 'Evaluation of Triclosan Coated Suture in Obstetrical Surgery: A Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'TunisU 1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Triclosan coated suture', 'interventionNames': ['Drug: Coated Vicryl+']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non coated suture', 'interventionNames': ['Drug: Vicryl']}], 'interventions': [{'name': 'Coated Vicryl+', 'type': 'DRUG', 'description': 'We used coated suture for : hystetrotomy reparation / aponeurosis and skin closure.', 'armGroupLabels': ['Triclosan coated suture']}, {'name': 'Vicryl', 'type': 'DRUG', 'description': 'We used non coated suture for : hystetrotomy reparation / aponeurosis and skin closure.', 'armGroupLabels': ['Non coated suture']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2096', 'city': 'Ben Arous', 'country': 'Tunisia', 'facility': 'Obstetrics and Gynecology Departement', 'geoPoint': {'lat': 36.75452, 'lon': 10.22167}}], 'overallOfficials': [{'name': 'Chaouki Mbarki', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ben Arous Hospital, Tunis, Tunisia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tunis University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Hajer BETTAIEB', 'investigatorAffiliation': 'Tunis University'}}}}