Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2026-01-18 @ 6:43 PM
Study NCT ID:
NCT02062866
Status:
COMPLETED
Last Update Posted:
2015-04-16
First Post:
2013-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Purse-String Closure Vs Second Intention
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': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-15', 'studyFirstSubmitDate': '2013-11-01', 'studyFirstSubmitQcDate': '2014-02-12', 'lastUpdatePostDateStruct': {'date': '2015-04-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of Scar on the Patient and Observer Scar Assessment Scale', 'timeFrame': '3 months', 'description': 'After surgical procedure, subjects will be randomized into one of two wound healing groups: by second intention (no sutures) or by purse-string closure (with sutures). After 3 months, subjects will return to clinic for evaluation of the pain scale and cosmesis of both types of healing techniques.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Wound Closure Techniques']}, 'referencesModule': {'references': [{'pmid': '25372450', 'type': 'DERIVED', 'citation': 'Joo J, Custis T, Armstrong AW, King TH, Omlin K, Kappel ST, Eisen DB. Purse-string suture vs second intention healing: results of a randomized, blind clinical trial. JAMA Dermatol. 2015 Mar;151(3):265-70. doi: 10.1001/jamadermatol.2014.2313.'}], 'seeAlsoLinks': [{'url': 'http://www.ucdmc.ucdavis.edu/dermatology/research/clinical', 'label': 'University of California-Davis Department of Dermatology Clinical Research'}]}, 'descriptionModule': {'briefSummary': 'To compare healing time, scar size, aesthetic outcome, and complication rates following second intention healing or purse string closure of surgical wounds on the trunk or extremities. This study, will allow surgeons to make informed decisions on whether purse string closure is superior to that of second intention healing and thus worth considering or inferior and not worth performing.'}, '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* Post-operative defects greater than 8 mm (in greatest diameter or length of circular or oval geometric shape) on the trunk and extremities (including the shin, hands, and feet)\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 8 mm in length\n* Wounds on the head, neck or digits\n* Patients in which primary linear closure is recommended'}, 'identificationModule': {'nctId': 'NCT02062866', 'briefTitle': 'Evaluation of Purse-String Closure Vs Second Intention', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'Intradermal Purse-String Closure Vs Second Intention Healing', 'orgStudyIdInfo': {'id': '407301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Purse-String', 'description': 'Surgical wounds are healed via suturing.', 'interventionNames': ['Procedure: Purse-String', 'Procedure: Second Intent']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Second Intent', 'description': 'Surgical wounds are allowed to heal without sutures.', 'interventionNames': ['Procedure: Purse-String', 'Procedure: Second Intent']}], 'interventions': [{'name': 'Purse-String', 'type': 'PROCEDURE', 'description': 'The wound will be closed using one, long, continuous suture which will enter and exit run through the skin along the inner edge of the wound. The start and stopping point will be adjacent to one another. The suture will then be pulled" on either side to essentially cinch down the wound, decreasing the size of the wound.', 'armGroupLabels': ['Purse-String', 'Second Intent']}, {'name': 'Second Intent', 'type': 'PROCEDURE', 'description': 'The wound will not be sutured, and allowed to heal on its own.', 'armGroupLabels': ['Purse-String', 'Second Intent']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95816', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California-Davis, Dept. 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'}}}}