Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2026-01-01 @ 12:36 AM
Study NCT ID:
NCT00196508
Status:
COMPLETED
Last Update Posted:
2007-10-16
First Post:
2005-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Comparing Topical Skin Adhesive or Sutures for Closure Due to Episiotomy or Perineal Tears Following Childbirth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 118}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-04'}, 'statusVerifiedDate': '2006-06', 'completionDateStruct': {'date': '2006-01'}, 'lastUpdateSubmitDate': '2007-10-13', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2007-10-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Topical skin adhesive is non-inferior to sutures when used for skin closure following an episiotomy incision or perineal tear resulting from childbirth'}, {'measure': 'The incidence of perineal skin opening requiring re-closure post-partum'}], 'secondaryOutcomes': [{'measure': 'Presence and extent of clinically relevant skin openings'}, {'measure': 'Presence and extent of acute inflammatory reaction, pain, itch and discomfort associated with the perineal skin area'}, {'measure': 'Perineal skin closure cosmesis'}, {'measure': 'Patient satisfaction'}]}, 'conditionsModule': {'keywords': ['Childbirth'], 'conditions': ['Episiotomy', 'Perineal Tear']}, 'descriptionModule': {'briefSummary': 'This is a randomized controlled trial and multi-centered study with a 2-arm design. The treatment group will receive topical skin adhesive for skin closure of their wound and the control will receive sutures. Subjects will be assessed at follow-up visits. Patients are required to maintain a diary postpartum.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is at least 18 years of age.\n* Patient has an episiotomy incision or perineal tear resulting from a vaginal delivery.\n* Patient agrees to participate in the follow-up schedule of assessments and completion of a daily diary.\n* Patient has signed the informed consent form.\n\nExclusion Criteria:\n\n* Patient has peripheral vascular disease.\n* Patient has insulin dependent diabetes mellitus.\n* Patient has a blood clotting disorder that requires therapy.\n* Patient has a personal or family history of keloid formation or hypertrophy.\n* Patient has a known allergy to cyanoacrylates or formaldehyde.\n* Patient has impaired wound healing by history. Patient is a chronic steroid user.'}, 'identificationModule': {'nctId': 'NCT00196508', 'briefTitle': 'A Study Comparing Topical Skin Adhesive or Sutures for Closure Due to Episiotomy or Perineal Tears Following Childbirth', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ethicon, Inc.'}, 'officialTitle': 'A Randomized, Multi Center Study to Evaluate the Clinical Performance of Topical Skin Adhesive in Comparison to Sutures for Perineal Skin Closure Following Childbirth', 'orgStudyIdInfo': {'id': '200-04-001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'High Viscosity DERMABOND', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35021', 'city': 'Bessemer', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.40178, 'lon': -86.95444}}, {'zip': '08057', 'city': 'Moorestown', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Phoenix OB-GYN Associates', 'geoPoint': {'lat': 39.96706, 'lon': -74.94267}}, {'zip': '38120', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': "McDonald Murrmann Women's Clinic", 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '23502', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Tidewater Physicians for Women', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '23454', 'city': 'Virginia Beach', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Beach Obstetrics & Gynecology', 'geoPoint': {'lat': 36.85293, 'lon': -75.97799}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ethicon, Inc.', 'class': 'INDUSTRY'}}}}