Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2026-03-03 @ 2:24 AM
Study NCT ID:
NCT01770002
Status:
COMPLETED
Last Update Posted:
2015-04-16
First Post:
2013-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Eversion in Dermatologic Surgery: Is Cosmetic Appearance Improved?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002280', 'term': 'Carcinoma, Basal Cell'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D008545', 'term': 'Melanoma'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018295', 'term': 'Neoplasms, Basal Cell'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-15', 'studyFirstSubmitDate': '2013-01-15', 'studyFirstSubmitQcDate': '2013-01-15', 'lastUpdatePostDateStruct': {'date': '2015-04-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Everted versus non-everted suturing techniques', 'timeFrame': '3 and 6 months', 'description': 'Primary outcome measures for this study are the post operative scar width measured at 1 cm from the midline on both sides of the scar.'}, {'measure': 'Mean score of sum of 2 blinded observers POSAS scores', 'timeFrame': '3 and 6 months', 'description': 'The mean summed total of two blinded reviewers Physician Observer Scar Assessment Scale (POSAS) scores for each side of the wound.'}, {'measure': 'Scar measurements (height, width, length)', 'timeFrame': '3 and 6 months', 'description': 'Scar volume will be measured in centimeters on both sides of the wound'}, {'measure': 'Scar induration', 'timeFrame': '3 and 6 months', 'description': 'Scar induration area will be measured in centimeters for both sides of the wound'}, {'measure': 'Scar erythema', 'timeFrame': '3 and 6 months', 'description': 'Scar erythema area will be measured in centimeters for both sides of the wound'}, {'measure': 'Wound contour irregularities', 'timeFrame': '3 and 6 months', 'description': 'Wound contour irregularities will be measured in terms of volume in cubic centimeters via a length, width and height measurement'}, {'measure': 'Stand cone volume', 'timeFrame': '3 and 6 months', 'description': 'The volume of standing cones will be measured via length, width and height measurements in centimeters'}, {'measure': 'Uneven edge measurement', 'timeFrame': '3 and 6 months', 'description': 'The area of uneven edges will be measured via a length x height measurement in centimeters'}, {'measure': 'Hyperpigmentation area', 'timeFrame': '3 and 6 months', 'description': 'areas of hyperpigmentation will be measured via a length x width measurement in centimeters'}], 'secondaryOutcomes': [{'measure': 'Infection', 'timeFrame': 'up to 6 months', 'description': 'Infections occurring anytime during the study period will be recorded'}, {'measure': 'wound dehiscence', 'timeFrame': 'up to 6 months', 'description': 'incidence of wound infection will be recorded anytime during the study period'}, {'measure': 'spitting sutures', 'timeFrame': '3 and 6 months', 'description': 'spitting sutures will be counted for each side of the wound at 3 and 6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Basal Cell Carcinoma', 'Squamous Cell Carcinoma', 'Melanoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.ucdmc.ucdavis.edu/dermatology/research/clinical', 'label': 'University of California-Davis Department of Dermatology Clinical Research'}]}, 'descriptionModule': {'briefSummary': 'The investigators hypothesize that everting wound edges while suturing surgical sites will result in more aesthetic scars. Additionally, we also hypothesize that small to moderate wound irregularities present at 3 months will resolve by 6 months after surgery with no intervention'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Over 18 years of age\n* Able to give informed consent themselves\n* Willing to return for follow up visits\n\nExclusion Criteria:\n\n* Mentally handicapped\n* Unable to understand written and oral English\n* Incarceration\n* Under 18 years of age\n* Unwilling to return for follow up\n* Pregnant Women\n* Wounds less than 3 cm in length'}, 'identificationModule': {'nctId': 'NCT01770002', 'briefTitle': 'Eversion in Dermatologic Surgery: Is Cosmetic Appearance Improved?', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'Eversion in Dermatologic Surgery: Is Cosmetic Appearance Improved?', 'orgStudyIdInfo': {'id': '265161'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Everted suture technique', 'description': 'Technique that everts the skin; the edges will sit up against each other in a little peak, raised above the surrounding skin.', 'interventionNames': ['Procedure: Everted suture technique']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non-everted suture technique', 'description': 'Surgical wound will be approximated such that the suture line is flat relative to the surrounding skin.', 'interventionNames': ['Procedure: Non-everted suture technique']}], 'interventions': [{'name': 'Everted suture technique', 'type': 'PROCEDURE', 'armGroupLabels': ['Everted suture technique']}, {'name': 'Non-everted suture technique', 'type': 'PROCEDURE', 'armGroupLabels': ['Non-everted suture technique']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95816', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'UC Davis, Department of Dermatology', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}], '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'}}}}