Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2025-12-25 @ 6:07 PM
Study NCT ID:
NCT01932359
Status:
COMPLETED
Last Update Posted:
2015-04-13
First Post:
2013-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rapidly Absorbable Versus Non-absorbable Sutures for Mohs Surgery Repair on the Face: a Randomized Controlled Split-scar Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002921', 'term': 'Cicatrix'}, {'id': 'D019066', 'term': 'Facies'}], 'ancestors': [{'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009757', 'term': 'Nylons'}], 'ancestors': [{'id': 'D010969', 'term': 'Plastics'}, {'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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-10', 'studyFirstSubmitDate': '2013-08-27', 'studyFirstSubmitQcDate': '2013-08-29', 'lastUpdatePostDateStruct': {'date': '2015-04-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stony Brook Scar Evaluation Scale (SBSES) score', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Scar outcome', 'Mohs surgery', 'face'], 'conditions': ['Scars']}, 'descriptionModule': {'briefSummary': 'This study aims to compare scar outcomes between rapidly absorbable and non-absorbable sutures (stitches) for the closure of wounds after skin cancer removal on the face.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mohs surgical wound on the face\n* Wound greater than or equal to 4 cm in length\n* Subject is willing and capable of cooperating to the extent and degree required by the protocol and will be able to come for follow-up assessments\n* Subject has read and signed Subject Information and Informed Consent Form\n\nExclusion Criteria:\n\n* Surgical wound less than 4 cm in length\n* Surgical site outside of face\n* Subject to be be treated with radiation therapy after surgery\n* Subject is not willing or able to attend for follow-up assessments'}, 'identificationModule': {'nctId': 'NCT01932359', 'acronym': 'RAVNAS', 'briefTitle': 'Rapidly Absorbable Versus Non-absorbable Sutures for Mohs Surgery Repair on the Face: a Randomized Controlled Split-scar Study', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'Rapidly Absorbable Versus Non-absorbable Sutures for Mohs Surgery Repair on the Face: a Randomized Controlled Split-scar Study (RAVNAS)', 'orgStudyIdInfo': {'id': 'H13-01961'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'rapidly absorbable suture (Vicryl Rapide)', 'interventionNames': ['Other: rapidly absorbable suture (Vicryl Rapide)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'non-absorbable suture (Ethilon)', 'interventionNames': ['Other: non-absorbable suture (Ethilon)']}], 'interventions': [{'name': 'rapidly absorbable suture (Vicryl Rapide)', 'type': 'OTHER', 'armGroupLabels': ['rapidly absorbable suture (Vicryl Rapide)']}, {'name': 'non-absorbable suture (Ethilon)', 'type': 'OTHER', 'armGroupLabels': ['non-absorbable suture (Ethilon)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V5Z 4E8', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Department of Dermatology and Skin Science, UBC, Vancouver General Hospital', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'David Zloty, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Columbia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}