Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2026-02-21 @ 4:08 AM
Study NCT ID:
NCT03968835
Status:
WITHDRAWN
Last Update Posted:
2020-05-29
First Post:
2019-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparison of the Outcomes of Distal Fingertip Amputations Treated With Either Artificial (Xeroform) or Biological Dressings
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005383', 'term': 'Finger Injuries'}, {'id': 'D000673', 'term': 'Amputation, Traumatic'}], 'ancestors': [{'id': 'D006230', 'term': 'Hand Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001414', 'term': 'Bacitracin'}, {'id': 'D016038', 'term': 'Skin Transplantation'}], 'ancestors': [{'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D016378', 'term': 'Tissue Transplantation'}, {'id': 'D064987', 'term': 'Cell- and Tissue-Based Therapy'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D062109', 'term': 'Dermatologic Surgical Procedures'}, {'id': 'D019651', 'term': 'Plastic Surgery Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D014180', 'term': 'Transplantation'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'lack of enrollment', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2018-12-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2021-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-27', 'studyFirstSubmitDate': '2019-05-08', 'studyFirstSubmitQcDate': '2019-05-28', 'lastUpdatePostDateStruct': {'date': '2020-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to complete healing up to 3 Months', 'timeFrame': '3 months'}, {'measure': 'Percentage of graft viability (for biological dressing only)', 'timeFrame': '1 week'}, {'measure': 'Percentage of graft viability (for biological dressing only)', 'timeFrame': '3 weeks'}, {'measure': 'Percentage of graft viability (for biological dressing only)', 'timeFrame': '6 weeks'}, {'measure': 'Percentage of graft viability (for biological dressing only)', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Finger Injuries', 'Amputation, Traumatic']}, 'descriptionModule': {'briefSummary': 'This is a prospective study looking to evaluate whether the treatment outcomes for patients who sustain a distal fingertip amputation are improved or no different when using biological dressings versus artificial dressings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '60 patients will be followed for the study. The first 30 patients will be treated with biological dressings and subsequent 30 patients will be treated with artificial dressings.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All individuals presenting at Bellevue Hospital for evaluation and treatment of a finger amputation distal to the germinal matrix that present along with the amputated distal fingertip unit.\n\nExclusion Criteria:\n\n* replantation candidate, incomplete distal finger-tip amputation'}, 'identificationModule': {'nctId': 'NCT03968835', 'briefTitle': 'A Comparison of the Outcomes of Distal Fingertip Amputations Treated With Either Artificial (Xeroform) or Biological Dressings', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'A Comparison of the Outcomes of Distal Fingertip Amputations Treated With Either Artificial (Xeroform) or Biological Dressings', 'orgStudyIdInfo': {'id': '18-00132'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Biological Dressings', 'description': 'Bacitracin will be applied and covered with xeroform and gauze', 'interventionNames': ['Other: Bacitracin']}, {'label': 'Artificial Dressings', 'description': 'the amputated composite skin and soft tissue unit will be thinned out to become a full thickness skin graft', 'interventionNames': ['Other: Skin Graft']}], 'interventions': [{'name': 'Bacitracin', 'type': 'OTHER', 'description': 'For the first 30 people, bacitracin will be applied and covered with xeroform and gauze.', 'armGroupLabels': ['Biological Dressings']}, {'name': 'Skin Graft', 'type': 'OTHER', 'description': 'For the next 30 patients, the amputated composite skin and soft tissue unit will be thinned out to become a full thickness skin graft.', 'armGroupLabels': ['Artificial Dressings']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Jacques Hacquebord', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New York Langone Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}