Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2026-01-20 @ 6:49 AM
Study NCT ID:
NCT02289859
Status:
COMPLETED
Last Update Posted:
2017-07-18
First Post:
2014-11-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Undermining During Cutaneous Wound Closure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-17', 'studyFirstSubmitDate': '2014-11-10', 'studyFirstSubmitQcDate': '2014-11-12', 'lastUpdatePostDateStruct': {'date': '2017-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-11-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of Scar on the Patient and Observer Scar Assessment Scale', 'timeFrame': '3 months', 'description': "After surgical procedure, half of the subject's wound will be closed after undermining, while the other half is closed without undermining. After 3 months, subjects will return to clinic for evaluation of the cosmesis of both types of closure techniques."}], 'secondaryOutcomes': [{'measure': 'Measurement of Scar Width', 'timeFrame': '3 months', 'description': 'The width of the scar will be measured 1 centimeter from the midline on both sides. There is no defined width that is considered satisfactory or not satisfactory. The measurements will be compared between subjects.'}, {'measure': 'Assessment of Complications', 'timeFrame': '3 months', 'description': 'Noting the presence or absence of bleeding, dehiscence, infection or spitting sutures.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Wound Closure Techniques']}, 'referencesModule': {'references': [{'pmid': '34546436', 'type': 'DERIVED', 'citation': 'Joo J, Pourang A, Tchanque-Fossuo CN, Armstrong AW, Tartar DM, King TH, Sivamani RK, Eisen DB. Undermining during cutaneous wound closure for wounds less than 3 cm in diameter: a randomized split wound comparative effectiveness trial. Arch Dermatol Res. 2022 Sep;314(7):697-703. doi: 10.1007/s00403-021-02280-5. Epub 2021 Sep 21.'}], 'seeAlsoLinks': [{'url': 'http://www.ucdmc.ucdavis.edu/dermatology/research/clinical', 'label': 'University of California-Davis Department of Dermatology Clinical Research'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether undermining during cutaneous surgery improves scar cosmesis compared to wound closure without undermining.', 'detailedDescription': 'The purpose of this study is to determine whether undermining during cutaneous surgery improves scar cosmesis compared to wound closure without undermining. Our aims are to compare outcomes using a split wound model, where half the wound is undermined and the other half is not. This will be measured via the physician observer scar assessment scale, a validated scar instrument and via wound width. Our hypothesis is that wound undermining will result in cosmetically superior wound outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to give informed consent themselves\n* Patient scheduled for cutaneous surgical procedure with predicted linear closure\n* Willing to return for follow up visits\n\nExclusion Criteria:\n\n* Mentally handicapped\n* Incarceration\n* Pregnant Women\n* Wounds with predicted closure length less than 3 cm\n* Wounds with diameter \\> 3 cm\n* Wounds unable to be fully closed without undermining'}, 'identificationModule': {'nctId': 'NCT02289859', 'briefTitle': 'Undermining During Cutaneous Wound Closure', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'Undermining During Cutaneous Wound Closure: a Randomized Split Wound Comparative Effectiveness Trial', 'orgStudyIdInfo': {'id': '613430'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Wound Closure with Undermining', 'description': 'The side assigned to undermining will have undermining performed prior to wound closure in the subcutaneous plane. The amount of undermining will range from 1 cm for wounds with low tension to 2 cm for those with moderate tension. Since wound diameter will be 3 cm or less and exclude the scalp, high tension wounds are not anticipated.', 'interventionNames': ['Procedure: Wound Closure with Undermining', 'Procedure: Wound Closure without Undermining']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Wound Closure without Undermining', 'description': 'One side of the wound will remain un-undermined.', 'interventionNames': ['Procedure: Wound Closure with Undermining', 'Procedure: Wound Closure without Undermining']}], 'interventions': [{'name': 'Wound Closure with Undermining', 'type': 'PROCEDURE', 'description': 'The side assigned to undermining will have undermining performed prior to wound closure in the subcutaneous plane. The amount of undermining will range from 1 cm for wounds with low tension to 2 cm for those with moderate tension. Since wound diameter will be 3 cm or less and exclude the scalp, high tension wounds are not anticipated.', 'armGroupLabels': ['Wound Closure with Undermining', 'Wound Closure without Undermining']}, {'name': 'Wound Closure without Undermining', 'type': 'PROCEDURE', 'description': 'One side of the wound will remain un-undermined.', 'armGroupLabels': ['Wound Closure with Undermining', 'Wound Closure without Undermining']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Daniel Eisen, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Davis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}