Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-01-25 @ 10:47 AM
Study NCT ID:
NCT02744950
Status:
COMPLETED
Last Update Posted:
2016-04-20
First Post:
2016-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Scar Results and Time for Closures of Scalp Defects Via Pulley Sutures or Layered Repairs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002921', 'term': 'Cicatrix'}], 'ancestors': [{'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-15', 'studyFirstSubmitDate': '2016-04-14', 'studyFirstSubmitQcDate': '2016-04-15', 'lastUpdatePostDateStruct': {'date': '2016-04-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-04-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to close wound', 'timeFrame': 'Depends on case typically 4-10 minutes', 'description': 'Time it takes to close the defect in each arm; measured in minutes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pulley', 'scalp defects'], 'conditions': ['Scar']}, 'descriptionModule': {'briefSummary': 'Surgical defects on the scalp require closure via various techniques of suture placement. A traditional technique requires both dermal (deep) and epidermal (superficial) placement of sutures to close the defect; this is referred to as intermediate or complex linear repair. However, the scalp is a location with high tension, and thus the closures take an hour or longer to perform. A type of suture placement referred to as the "pulley stitch" requires placement of a few stitches along the defect. The pulley stitch can be used in areas of high tension to close a large defect. The purpose of this study is to compare the scar results and time taken to perform scalp closures via only pulley stitches or via intermediate/complex linear repairs.\n\nTo my knowledge, no such study has been performed to compare the two techniques. Such a study would be useful in demonstrating comparable scar appearance and reduce the time to perform scalp closures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age greater than 18 years\n2. Ability to understand risks, benefits, and alternatives to the study and to be able to give an informed consent\n3. Lesions such as skin cancer or benign lesions on the scalp amenable to surgical excision or to MOHS surgical technique\n4. Frontal scalp defects defined as frontal hair line to crown of scalp\n5. Scalp defect size of 2cm - 8 cm\n\nExclusion criteria:\n\n1. Patients who tend to form keloids or hypertrophic scars\n2. Patients with a history of scleroderma or morphea\n3. Pregnant or breast-feeding females\n4. Patients whose surgical defects require flap closures'}, 'identificationModule': {'nctId': 'NCT02744950', 'briefTitle': 'Comparison of Scar Results and Time for Closures of Scalp Defects Via Pulley Sutures or Layered Repairs', 'organization': {'class': 'OTHER', 'fullName': 'Henry Ford Health System'}, 'officialTitle': 'A Prospective, Randomized Study to Evaluate the Efficacy of Pulley Closures Compared to Intermediate or Complex Closures for Reconstruction of Scalp Surgical Defects', 'orgStudyIdInfo': {'id': 'SK1234'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intermediate/complex repair', 'description': 'This arm will have closures of scalp defects with deep and superficial suture placement.', 'interventionNames': ['Procedure: Intermediate Repair']}, {'type': 'EXPERIMENTAL', 'label': 'Pulley stitches', 'description': 'This arm of the study will have only pulley stitches to close the entire defect.', 'interventionNames': ['Procedure: Pulley stitches']}], 'interventions': [{'name': 'Pulley stitches', 'type': 'PROCEDURE', 'armGroupLabels': ['Pulley stitches']}, {'name': 'Intermediate Repair', 'type': 'PROCEDURE', 'armGroupLabels': ['Intermediate/complex repair']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Health System- Dermatology', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Via a research paper'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henry Ford Health System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dermatologist', 'investigatorFullName': 'David M. Ozog', 'investigatorAffiliation': 'Henry Ford Health System'}}}}