Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT03717220
Status:
COMPLETED
Last Update Posted:
2018-10-24
First Post:
2018-10-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Reconstructive of Multiple-digit Soft-tissue Defects Using Regional Dorsal Digital Flaps
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005383', 'term': 'Finger Injuries'}], 'ancestors': [{'id': 'D006230', 'term': 'Hand Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2016-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-22', 'studyFirstSubmitDate': '2018-10-22', 'studyFirstSubmitQcDate': '2018-10-22', 'lastUpdatePostDateStruct': {'date': '2018-10-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-05-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Static 2PD test', 'timeFrame': '18 months to 24 months', 'description': 'We use a Disk-Criminator to test two nearby points when touching the flap'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['soft-tissue defects', 'dorsal branch of the digital artery', 'regional flap'], 'conditions': ['Finger Injuries']}, 'referencesModule': {'references': [{'pmid': '23810451', 'type': 'BACKGROUND', 'citation': 'Chen C, Tang P, Zhang L, Li X, Zheng Y. Repair of multiple finger defects using the dorsal homodigital island flaps. Injury. 2013 Nov;44(11):1582-8. doi: 10.1016/j.injury.2013.05.019. Epub 2013 Jun 28.'}]}, 'descriptionModule': {'briefSummary': 'Reconstruction of soft-tissue defects in multiple digits poses a significant challenge. This article reports simultaneous reconstruction of multiple small-to-moderate soft-tissue defects using regional dorsal digital island flaps and evaluated the efficacy of their application in such complex situation. A retrospective study will be conducted with 26 patients who had multiple-digit soft-tissue defects treated with regional dorsal digital island flaps. At the final follow-up, we will evaluate the efficacy of their application in such complex situation.', 'detailedDescription': 'For the recipient where sensory restoration is important, sensation of the flaps is assessed using static two-point discrimination (2PD) and Semmes-Weinstein monofilament (SWM) testing at final follow-up. The cold intolerance of the injured finger is measured using the self-administered Cold Intolerance Severity Score questionnaire that was rated into mild, moderate, severe, and extreme (0-25, 26-50, 51-75 and 76-100). The pain of the injured finger is given subjectively by the patient using a grading system that included grade 1, none; grade 2, mild, no interference with daily activities; grade 3, moderate, patient works but has some limitation in use of the hand because of pain; and grade 4, severe, cannot work or use hand. To sum up, patients report their satisfaction with functional recovery of the injured finger according to the Michigan Hand Outcomes Questionnaire that was based on a 5-point response scale.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* the separate soft tissue defects with exposed bone or tendon in different digits\n* the soft-tissue defect≥1.5 cm and ≤3.5 cm in length\n* necessity to preserve digit length\n* local tissue near the defect can be used as the donor\n* a patient between 15 and 60 years of age\n\nExclusion Criteria:\n\n* concomitant injuries to the dorsum of the injured finger\n* a defect \\< 1.5 cm and\\>3.5 cm in length\n* a finger degloving injury\n* the defect of the thumb'}, 'identificationModule': {'nctId': 'NCT03717220', 'briefTitle': 'Reconstructive of Multiple-digit Soft-tissue Defects Using Regional Dorsal Digital Flaps', 'organization': {'class': 'OTHER', 'fullName': 'The Second Hospital of Tangshan'}, 'officialTitle': 'Reconstructive of Multiple-digit Soft-tissue Defects Using Regional Dorsal Digital Flaps', 'orgStudyIdInfo': {'id': 'TSChen13476'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'flaps', 'description': 'flap transferring is used for reconstruction of multiple small-to-moderate soft-tissue defects', 'interventionNames': ['Procedure: flap transferring']}], 'interventions': [{'name': 'flap transferring', 'type': 'PROCEDURE', 'description': 'we use regional dorsal digital flaps for simultaneous reconstruction of multiple-digit soft-tissue defects', 'armGroupLabels': ['flaps']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Second Hospital of Tangshan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}