Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-25 @ 7:55 PM
Study NCT ID:
NCT04652635
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-14
First Post:
2020-11-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Management of Nailbed Injuries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': '6 month appearance will be assessed by a blinded individual'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2050-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-09', 'studyFirstSubmitDate': '2020-11-26', 'studyFirstSubmitQcDate': '2020-11-26', 'lastUpdatePostDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2050-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants who experience complications over time', 'timeFrame': '6 months', 'description': 'Any complication, including but not limited to infection or wound healing complications'}, {'measure': 'Change in pain score over time as measured on a pain scale', 'timeFrame': '6 months', 'description': 'Scored from 0-10 (higher scores indicate worse pain)'}, {'measure': 'Change in cosmetic appearance over time as measured by the Oxford Finger Nail Appearance Score', 'timeFrame': '6 months', 'description': 'Oxford Finger Nail Appearance Score (OFNAS), ranges from 0 to 5 (5 is the best appearance)'}, {'measure': 'Change in upper extremity function over time as measured by the QuickDash score', 'timeFrame': '6 months', 'description': 'Quick Disabilities of Arm, Shoulder, \\& Hand (QuickDASH) score, ranges from 0 (no disability) to 100 (most severe disability)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nail Bed Injury']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine whether nail plate removal in suspected nailbed injury improves patient outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* any individual greater than or equal to 2 years of age presenting with a suspected nailbed injury (laceration adjacent to or through nail plate and/or subungual hematoma) with the nail plate present\n\nExclusion Criteria:\n\n* nail plate absent over the nailbed injury'}, 'identificationModule': {'nctId': 'NCT04652635', 'briefTitle': 'Management of Nailbed Injuries', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Management of Nailbed Injuries', 'orgStudyIdInfo': {'id': '59042'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Nail plate removal, nail bed repair', 'description': 'Participants will undergo nail plate removal and nail bed repair, and follow up at clinic visits at 1 week, 3 months, and 6 months', 'interventionNames': ['Procedure: Nail plate removal, nail bed repair']}, {'type': 'NO_INTERVENTION', 'label': 'Observation', 'description': 'Participants will follow up at clinic visits at 1 week, 3 months, and 6 months'}], 'interventions': [{'name': 'Nail plate removal, nail bed repair', 'type': 'PROCEDURE', 'description': 'Injection of local anesthetic, removal of nail plate, inspection of nail bed, repair of nail bed with suture and/or adhesive', 'armGroupLabels': ['Nail plate removal, nail bed repair']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Study Team', 'role': 'CONTACT', 'email': 'aluan@stanford.edu', 'phone': '650-723-5643'}], 'overallOfficials': [{'name': 'Anna Luan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}, {'name': 'Jeffrey Yao, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident in Surgery', 'investigatorFullName': 'Anna Luan', 'investigatorAffiliation': 'Stanford University'}}}}