Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2026-03-05 @ 7:05 PM
Study NCT ID:
NCT01629602
Status:
COMPLETED
Last Update Posted:
2012-06-27
First Post:
2012-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Soft Tissue Loss With Nerve Defect in the Finger Using the Boomerang Nerve Flap
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-26', 'studyFirstSubmitDate': '2012-06-22', 'studyFirstSubmitQcDate': '2012-06-26', 'lastUpdatePostDateStruct': {'date': '2012-06-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'static 2-point discrimination test', 'timeFrame': 'from 18 to 24 months', 'description': 'The test points were at the centers of the radial and ulnar portions of the finger pulp, the flap and the donor sites separately.'}], 'secondaryOutcomes': [{'measure': 'Cold Intolerance Severity Score (CISS) questionnaire', 'timeFrame': 'from 18 to 24 months', 'description': 'The maximum score was 100 and was grouped into mild (0-25), moderate (26-50), severe (51-75) and extreme severity (76-100).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['defect;', 'dorsal branch of the proper digital nerve;', 'proper digital nerve;', 'vascularized nerve graft'], 'conditions': ['Soft Tissue Loss With Nerve Defect']}, 'referencesModule': {'references': [{'pmid': '23271553', 'type': 'DERIVED', 'citation': 'Chen C, Tang P, Zhang X. Treatment of soft-tissue loss with nerve defect in the finger using the boomerang nerve flap. Plast Reconstr Surg. 2013 Jan;131(1):44e-54e. doi: 10.1097/PRS.0b013e3182729f5e.'}]}, 'descriptionModule': {'briefSummary': 'Soft tissue loss with proper digital nerve (PDN) defect in the finger results in sensory loss of the finger pulp. Reconstruction of these complex soft tissue defects continues to be a challenge problem. To resolve this problem, we combined the nerve branch with the boomerang flap for simultaneous repair of soft tissue loss and PDN defect in these awkward areas. For comparison, we also collected a consecutive series of 32 patients with similar injury in the finger treated using a cross finger flap and a secondary free nerve graft.', 'detailedDescription': 'The patients in this study group were required to meet all of the following criteria: soft tissue loss between the midpoint of the distal phalanx and PIP joint; associated PDN defect 1 to 4 cm in length; single or double PDN defects; and simultaneous repair of soft tissue loss and PDN defect. Patients were excluded when they had the following: injury to the course of the vascular pedicle or the donor site or the donor nerve; PDN defect less than 1 cm or larger than 4 cm in length; direct PDN repair; and thumb neurocutaneous defects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* soft tissue loss between the midpoint of the distal phalanx and PIP joint; - associated PDN defect 1 to 4 cm in length;\n* single or double PDN defects;\n* simultaneous repair of soft tissue loss and PDN defect.\n\nExclusion Criteria:\n\n* injury to the course of the vascular pedicle or the donor nerve;\n* PDN defect less than 1 cm or larger than 4 cm in length;\n* direct PDN repair;\n* thumb neurocutaneous defects.'}, 'identificationModule': {'nctId': 'NCT01629602', 'briefTitle': 'Treatment of Soft Tissue Loss With Nerve Defect in the Finger Using the Boomerang Nerve Flap', 'organization': {'class': 'OTHER', 'fullName': 'The Second Hospital of Tangshan'}, 'orgStudyIdInfo': {'id': 'TSChen4112'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'vascularized nerve graft', 'description': 'The investigators combined the nerve branch with the boomerang flap for simultaneous repair of soft tissue loss and PDN defect in these awkward areas.', 'interventionNames': ['Procedure: the Boomerang Nerve Flap']}], 'interventions': [{'name': 'the Boomerang Nerve Flap', 'type': 'PROCEDURE', 'description': 'The nerve branch was combined with the boomerang flap for simultaneous repair of soft tissue loss and PDN defect in these awkward areas.', 'armGroupLabels': ['vascularized nerve graft']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Second Hospital of Tangshan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}