Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2026-02-24 @ 2:06 PM
Study NCT ID:
NCT06647394
Status:
WITHDRAWN
Last Update Posted:
2025-05-25
First Post:
2024-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Application of Myriad Matrix to Split Thickness Skin Graft Sites
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'The study never opened or enrolled any subjects.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2028-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-21', 'studyFirstSubmitDate': '2024-10-16', 'studyFirstSubmitQcDate': '2024-10-16', 'lastUpdatePostDateStruct': {'date': '2025-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Improvement', 'timeFrame': '48 hours, 2 weeks, 4-6 weeks post operative visit', 'description': 'patients will rate pain level at donor site'}, {'measure': 'Wound Healing', 'timeFrame': '2 weeks and 4-6 weeks post operative visit', 'description': 'Patients will rate appearance of would using the scar-Q questionnaire'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Skin Grafts']}, 'descriptionModule': {'briefSummary': 'To determine if application of Myriad Matrix to split thickness skin graft donor sites improves post-operative pain and appearance of the wound.', 'detailedDescription': 'In the head and neck practice at UAB, split thickness skin grafts are a commonly used procedure for simple reconstruction. The standard dressing for donor sites is a strip of vaseline gauze which remains on the site the wound dries, and the gauze eventually falls off. Post operative pain and poor wound healing is a well established complication of the donor site, and various methods have been studied in an attempt to reduce these complications for patients in the post operative period. (1, 2, 3)\n\nMyriad matrix is an engineered extracellular matrix (Ovine Forestomach Matrix) used for soft issue repair in complex wounds. This has been sporadically used by some of the faculty members at UAB for split thickness skin graft donor site dressings with anectodal improvement in pain and healing, though this has not yet been studied to our knowledge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients undergoing a split thickness skin graft', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients 18 and over who are undergoing a split thickness skin graft at UAB.\n\nExclusion Criteria:\n\n* Patients who are not planned to undergo a split thickness skin graft or who are unable or do not plan to attend follow up appointments will not be included.'}, 'identificationModule': {'nctId': 'NCT06647394', 'briefTitle': 'Efficacy of Application of Myriad Matrix to Split Thickness Skin Graft Sites', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'Efficacy of Application of Myriad Matrix to Split Thickness Skin Graft Sites', 'orgStudyIdInfo': {'id': 'IRB-300013305'}, 'secondaryIdInfos': [{'id': 'UAB', 'type': 'OTHER', 'domain': 'UAB'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Matrix Dressing', 'type': 'PROCEDURE', 'description': 'extracellular matrix dressing soaked in 4% topical lidocaine to the skin graft donor site'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Benjamin Greene', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}