Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2025-12-25 @ 4:58 PM
Study NCT ID:
NCT04880603
Status:
TERMINATED
Last Update Posted:
2022-05-13
First Post:
2021-05-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Utility of Restrata With Split-thickness Skin Graft to Reconstruct the Forearm Donor Site
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'whyStopped': 'Investigators no longer interested in pursuing', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-04-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-04-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-09', 'studyFirstSubmitDate': '2021-05-05', 'studyFirstSubmitQcDate': '2021-05-05', 'lastUpdatePostDateStruct': {'date': '2022-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tendon exposure', 'timeFrame': '4 weeks post-operation', 'description': 'Tendon exposure at four weeks post-operatively (Yes/No).'}, {'measure': 'Percentage of surface area', 'timeFrame': '4 weeks post operation', 'description': 'Percentage of surface area of split-thickness skin graft incorporation at four weeks postoperatively.'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Head and Neck Cancer']}, 'descriptionModule': {'briefSummary': 'Adult patients undergoing a radial forearm free flap or ulnar forearm free flap will be randomized to the use of the Restrata graft in combination with split-thickness skin graft for reconstruction. Photos will document whether the Restata graft aids in the healing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients age 19 or greater that will undergo radial forearm free flap or ulnar free flap.\n* Photo documentation of wound bed at two weeks and four weeks must be obtainable either by physician or patient.\n\nExclusion Criteria:\n\n* Active systemic immunosuppression (active use of high-dose steroids (≥40mg prednisone daily or equivalent) or other immunosuppressive medications OR medical conditions causing immunosuppression, i.e. human immunodeficiency virus etc).\n* Diabetes mellitus with most recent Hemoglobin A1c ≥10.0 within 30 days prior to surgery.\n* Morbid obesity (BMI \\>40).\n* Inability to maintain wrist immobilization for full planned period.\n* Severe malnutrition (prealbumin levels \\<10 mg per dL within 30 days prior to surgery OR BMI \\<15 (very severely underweight).\n* Other conditions felt to significantly impair wound healing per surgeon discretion'}, 'identificationModule': {'nctId': 'NCT04880603', 'briefTitle': 'Utility of Restrata With Split-thickness Skin Graft to Reconstruct the Forearm Donor Site', 'organization': {'class': 'OTHER', 'fullName': 'Nebraska Methodist Health System'}, 'officialTitle': 'Utility of Restrata With Split-thickness Skin Graft to Reconstruct the Forearm Donor Site', 'orgStudyIdInfo': {'id': 'Restrata'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A - Standard of Care', 'interventionNames': ['Procedure: Standard of Care Skin Graft']}, {'type': 'EXPERIMENTAL', 'label': 'B - Restrata Graft', 'interventionNames': ['Device: Restrata Graft']}], 'interventions': [{'name': 'Restrata Graft', 'type': 'DEVICE', 'description': "Restrata will be meshed in a 1:2 fashion to allow for egress of serous fluid and minimize risk of fluid collection. Restrata will be applied to the entire wound bed not amenable to primary closure and will be underlaid beneath the surrounding skin edges. A split-thickness skin graft is harvested from patient's thigh at 15:1000 inches and placed on top of the Restrata to cover the entire wound bed. The graft is sutured in place using suture choice of surgeon's preference.", 'armGroupLabels': ['B - Restrata Graft']}, {'name': 'Standard of Care Skin Graft', 'type': 'PROCEDURE', 'description': 'Standard of Care Skin Graft', 'armGroupLabels': ['A - Standard of Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68114', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Nebraska Methodist Hospital', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}], 'overallOfficials': [{'name': 'Robert Lindau, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nebraska Methodist Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nebraska Methodist Health System', 'class': 'OTHER'}, 'collaborators': [{'name': 'Acera Surgical, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}