Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-27 @ 11:57 PM
Study NCT ID:
NCT04656834
Status:
UNKNOWN
Last Update Posted:
2020-12-07
First Post:
2020-11-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hand Incision Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2020-11-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2021-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-04', 'studyFirstSubmitDate': '2020-11-23', 'studyFirstSubmitQcDate': '2020-12-04', 'lastUpdatePostDateStruct': {'date': '2020-12-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Participant Satisfaction with Scar Appearance (Questionnaire #1)', 'timeFrame': '12 weeks', 'description': 'Participant will be asked to answer a series of questions regarding the cosmetic appearance of their surgical scar and how satisfied they are with the appearance of the scar as measured by the Patient Scar Assessment Questionnaire (PSAQ).'}, {'measure': 'Participant Satisfaction with Scar Appearance (Questionnaire #2)', 'timeFrame': '12 weeks', 'description': 'Participant will be asked to answer a series of questions regarding the cosmetic appearance of their surgical scar and how satisfied they are with the appearance of the scar as measured by the Stony Brook Scar Evaluation Scale (SBSES)'}, {'measure': 'Participant Satisfaction with Scar Appearance (Questionnaire #3)', 'timeFrame': '12 weeks', 'description': 'Participant will be asked to answer a series of questions regarding the cosmetic appearance of their surgical scar and how satisfied they are with the appearance of the scar as measured by the Visual Analog Scale (VAS)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hand Surgery']}, 'descriptionModule': {'briefSummary': "The cosmetic outcome of a patient's surgical scar is important for patient satisfaction, especially in more visibly exposed areas of the body such as the hand. A patient's surgical scar often serves as a long-term reminder of their surgery experience, so optimizing final scar appearance should be of high importance. Surgical incision closure techniques and suture materials may vary by individual hand surgeons, even with common hand procedures."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants who are 18 years old or older who are having surgery for either a trigger finger release or carpal tunnel release by one of Rothman Orthopaedics Hand \\& Wrist Surgeons', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients ≥ 18 years old\n* Able to provide consent\n* Undergoing either trigger finger release or carpal tunnel release\n\nExclusion Criteria:\n\n* Patients \\< 18 years old\n* Unable to provide consent\n* Unable to comply with follow up requirements'}, 'identificationModule': {'nctId': 'NCT04656834', 'briefTitle': 'Hand Incision Study', 'organization': {'class': 'OTHER', 'fullName': 'Rothman Institute Orthopaedics'}, 'officialTitle': 'Hand Surgical Incision Outcomes', 'orgStudyIdInfo': {'id': 'AILY20D.947'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hand incision closure type 1', 'description': 'The participating surgeon closes the hand surgical incision via the standard method based on personal preference: buried monocryl sutures and skin glue', 'interventionNames': ['Procedure: hand incision closure using monocryl sutures and skin glue']}, {'label': 'Hand incision closure type 2', 'description': 'The participating surgeon closes the hand surgical incision via the standard method based on personal preference: simple nylon sutures', 'interventionNames': ['Procedure: hand incision closure using simple nylon sutures']}], 'interventions': [{'name': 'hand incision closure using monocryl sutures and skin glue', 'type': 'PROCEDURE', 'description': 'At the end of surgery, the investigator will close the incision using monocryl sutures and skin glue', 'armGroupLabels': ['Hand incision closure type 1']}, {'name': 'hand incision closure using simple nylon sutures', 'type': 'PROCEDURE', 'description': 'At the end of surgery, the investigator will close the incision using simple nylon sutures', 'armGroupLabels': ['Hand incision closure type 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Rothman Orthopaedic Institute', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rothman Institute Orthopaedics', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}