Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-27 @ 11:33 PM
Study NCT ID:
NCT04621994
Status:
UNKNOWN
Last Update Posted:
2020-11-09
First Post:
2020-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cesarean Wound Closure: Dermabond Versus Steri Strips
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002921', 'term': 'Cicatrix'}], 'ancestors': [{'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C100832', 'term': 'octyl 2-cyanoacrylate'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 133}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2022-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-06', 'studyFirstSubmitDate': '2020-10-30', 'studyFirstSubmitQcDate': '2020-11-06', 'lastUpdatePostDateStruct': {'date': '2020-11-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient and Observer Scar Assessment Scale Surveys (POSAS)', 'timeFrame': 'at 1 weeks postpartum', 'description': 'Validated scale comparing a scar to normal skin. Score ranges from 6 to 60 with the higher numbers less like normal skin.'}, {'measure': 'Patient and Observer Scar Assessment Scale Surveys', 'timeFrame': 'at 6 weeks postpartum', 'description': 'Validated scale comparing a scar to normal skin. Score ranges from 6 to 60 with the higher numbers less like normal skin.'}], 'secondaryOutcomes': [{'measure': 'Number of patients with wound infection', 'timeFrame': 'through 6 weeks postpartum'}, {'measure': 'Number of patients with wound separation or dehiscence', 'timeFrame': 'through 6 weeks postpartum'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Scar']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine overall patient satisfaction with their cesarean section scar with application of Steri-strips vs. Dermabond following subcuticular skin closure of pfannenstiel incision'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women age 18-45 who are undergoing planned or unscheduled cesarean section at Regional One Health\n* Gestational age \\> 24 weeks\n* Planned Pfannenstiel incision\n* Willing to consent to the study\n\nExclusion Criteria:\n\n* Emergency or urgent cesarean section\n* Vertical skin incision\n* Intrapartum intraamniotic infection\n* Diabetes\n* Unwilling to consent to the study'}, 'identificationModule': {'nctId': 'NCT04621994', 'briefTitle': 'Cesarean Wound Closure: Dermabond Versus Steri Strips', 'organization': {'class': 'OTHER', 'fullName': 'University of Tennessee'}, 'officialTitle': 'Cesarean Wound Closure: Dermabond Versus Steri Strips', 'orgStudyIdInfo': {'id': '20-07302-FB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Steri Strips Arm', 'interventionNames': ['Other: Steri Strips']}, {'type': 'EXPERIMENTAL', 'label': 'Dermabond Arm', 'interventionNames': ['Other: Dermabond']}], 'interventions': [{'name': 'Dermabond', 'type': 'OTHER', 'description': 'Dermabond will be applied after subcuticular skin closure in lieu of Steri Strips', 'armGroupLabels': ['Dermabond Arm']}, {'name': 'Steri Strips', 'type': 'OTHER', 'description': 'Steri Strips will be applied after subcuticular skin closure as routinely done at our institution', 'armGroupLabels': ['Steri Strips Arm']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Tennessee', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Laura Grese Willingham', 'investigatorAffiliation': 'University of Tennessee'}}}}