Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2026-03-10 @ 8:37 PM
Study NCT ID:
NCT02768467
Status:
COMPLETED
Last Update Posted:
2019-06-05
First Post:
2016-05-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Buccal Mucosa Healing Trial With Tissue Matrix Placement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2018-04-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-03', 'studyFirstSubmitDate': '2016-05-09', 'studyFirstSubmitQcDate': '2016-05-10', 'lastUpdatePostDateStruct': {'date': '2019-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-04-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Level', 'timeFrame': 'Six months', 'description': 'Measured by the Visual Analog Scale'}], 'secondaryOutcomes': [{'measure': 'Time to Normal Eating', 'timeFrame': 'Six Months', 'description': 'This is measured by time.'}, {'measure': 'Presence of Swelling', 'timeFrame': 'Six Months', 'description': 'This is measured by time'}, {'measure': 'Mouth mobility', 'timeFrame': 'Six Months', 'description': 'This is measured by time'}, {'measure': 'Presence of Paresthesia', 'timeFrame': 'Six Months', 'description': 'This is measured by time'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Alloderm graft', 'Allograft', 'Buccal Mucosa'], 'conditions': ['Tissue Grafts']}, 'descriptionModule': {'briefSummary': "Prior studies have been performed to understand the optimal way to minimize the morbidity rate of buccal mucosa. While some studies have reported primary closure to be inferior to healing by secondary intention, this appears to be true for large defects greater than 2 cm in width. For small defects for which the wound can be closed without tension, the most recent study has shown improved pain outcomes in the immediate post-operative setting, although no difference is seen long term whether or not the wound was primarily closed. However, for larger defects, standard practice is to allow delayed healing by secondary intention.\n\nThe use of Alloderm graft placement for donor site coverage was first described in Armenakas' group. Alloderm is an acellular dermal lattice from human allograft skin. The only study to report the use of Alloderm failed to find a significant improvement in patient outcomes; however, very small defects were included in this study and the control group underwent primary closure, which has been shown to be inferior for large defects. Importantly, no increase in post-operative pain was noted, although there was some increased swelling reported. From experience, patients with moderate and large (\\>2 cm width) defects following buccal mucosa harvest benefit from Alloderm placement with decreased post-operative pain, more rapid resumption of normal diet and mouth function with no associated increase in morbidity of the procedure. This study aims to determine whether this is a reliable improvement in technique.\n\nThis study will clarify how the cheek heals after the buccal mucosa is removed during reconstructive surgery. Subjects will be randomized to either receive tissue collagen matrix or no stitches after the surgery. Subjects will be evaluated up to six months to determine if the outcomes of the tissue matrix graft are better for the subject."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>18 years of age\n* Male\n* Patients with clinically necessary buccal mucosal graft \\>2 cm\n* Patients who are able to present for pre-operative and post-operative evaluations\n* Patients who are able to comprehend and read English\n\nExclusion Criteria:\n\n* History of oral cancer\n* Severe cognitive impairments\n* Unwilling or unable to follow procedures in protocol\n* Contraindicated to participate for any reason'}, 'identificationModule': {'nctId': 'NCT02768467', 'briefTitle': 'Buccal Mucosa Healing Trial With Tissue Matrix Placement', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'A Prospective Randomized Controlled Trial of Buccal Mucosa Donor Site Healing With Tissue Matrix Placement', 'orgStudyIdInfo': {'id': '16-00669'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tissue Matrix Graft Placement', 'description': 'After the buccal mucosa is removed during reconstructive surgery, the wound is covered with an acellular tissue collagen matrix', 'interventionNames': ['Procedure: Tissue Matrix Graft Placement']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Without stitches', 'description': 'After the buccal mucosa is removed during reconstructive surgery, no stitches will be used for the wound to heal.', 'interventionNames': ['Procedure: No Stitches']}], 'interventions': [{'name': 'Tissue Matrix Graft Placement', 'type': 'PROCEDURE', 'description': 'Subject will receive a covering for the wound post buccal mucosa removal.', 'armGroupLabels': ['Tissue Matrix Graft Placement']}, {'name': 'No Stitches', 'type': 'PROCEDURE', 'description': 'Subject will not receive stitches post buccal mucosa removal.', 'armGroupLabels': ['Without stitches']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University Langone Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Lee Zhao, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Langone Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}