Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2026-02-07 @ 10:24 AM
Study NCT ID:
NCT01927003
Status:
COMPLETED
Last Update Posted:
2018-10-29
First Post:
2013-08-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Direct and Reversed Dorsal Digito-metacarpal Flaps: A Review of 24 Cases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005383', 'term': 'Finger Injuries'}, {'id': 'D017695', 'term': 'Soft Tissue 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': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-04', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-25', 'studyFirstSubmitDate': '2013-08-19', 'studyFirstSubmitQcDate': '2013-08-19', 'lastUpdatePostDateStruct': {'date': '2018-10-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-08-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Static 2-point discrimination test', 'timeFrame': '18 to 24months', 'description': 'The Static 2-point discrimination test determines the minimal distance at which a subject can sense the presence of two needle. The modified American Society for Surgery of the Hand guidalines are used to stratify discriminator measurements(excellent \\<6 mm, good 6-10 mm, fair 11-15 mm, poor \\>15 mm). Each area is tested 3 times with a Discriminator (Ali Med, Dedham, MA). Two out of 3 correct answers are considered proof of perception before proceeding to another lower value. We stopped at 4mm as a limit of 2PD and considered this normal. The measurements are performed at a single time point at final follow up.'}], 'secondaryOutcomes': [{'measure': 'Patient satisfaction', 'timeFrame': '18 to 24 months', 'description': 'Patients report their satisfaction with the appearance of the flap and the donor site according to the Michigan Hand Outcomes Questionnaire that is based on a 5-point response scale.'}]}, 'conditionsModule': {'keywords': ['defect,', 'dorsal branch of the digital artery,', 'dorsal digital flap,', 'dorsal metacarpal artery flap.'], 'conditions': ['Finger Injuries', 'Soft Tissue Injuries']}, 'referencesModule': {'references': [{'pmid': '11324891', 'type': 'RESULT', 'citation': 'Yang D, Morris SF. Reversed dorsal digital and metacarpal island flaps supplied by the dorsal cutaneous branches of the palmar digital artery. Ann Plast Surg. 2001 Apr;46(4):444-9. doi: 10.1097/00000637-200104000-00017.'}, {'pmid': '24315482', 'type': 'DERIVED', 'citation': 'Chen C, Zhang W, Tang P. Direct and reversed dorsal digito-metacarpal flaps: a review of 24 cases. Injury. 2014 Apr;45(4):805-12. doi: 10.1016/j.injury.2013.11.002. Epub 2013 Nov 13.'}]}, 'descriptionModule': {'briefSummary': 'Multiple digital injuries are often complex and severe, and the commonly used local and regional flaps may not be feasible. The authors reconstruct soft tissue defects of the fingers using the dorsal digito-metacarpal flap and evaluate the efficacy of this technique.', 'detailedDescription': 'At final follow-up, we measure the sensibility of the flaps using the static 2-point discrimination test. The Static 2-point discrimination test determines the minimal distance at which a subject can sense the presence of two needle. The modified American Society for Surgery of the Hand guidalines are used to stratify discriminator measurements(excellent \\<6 mm, good 6-10 mm, fair 11-15 mm, poor \\>15 mm). Each area is tested 3 times with a Discriminator (Ali Med, Dedham, MA). Two out of 3 correct answers are considered proof of perception before proceeding to another lower value. We stopp at 4mm as a limit of 2PD and consider this normal. The measurements are performed at a single time point at final follow up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '55 Years', 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* the injured and adjacent fingers are unable to be used as the donor due to multiple digital injuries\n* a soft tissue defect \\> 1.5 cm in length with exposed bone or tendon\n* the reverse DMA flap may not be appropriate for tissue reconstruction due to the concomitant injuries or due to the limitation of the rotation arc\n* a patient between 15 and 60 years of age\n\nExclusion Criteria:\n\n* concomitant injuries involved all the finger that precluded their use as donor sites\n* a defect less than 1.5 cm in length\n* injuries to the course of the vascular pedicle'}, 'identificationModule': {'nctId': 'NCT01927003', 'briefTitle': 'Direct and Reversed Dorsal Digito-metacarpal Flaps: A Review of 24 Cases', 'organization': {'class': 'OTHER', 'fullName': 'The Second Hospital of Tangshan'}, 'officialTitle': 'Direct and Reversed Dorsal Digito-metacarpal Flaps: A Review of 24 Cases', 'orgStudyIdInfo': {'id': 'HBTS1308112'}, 'secondaryIdInfos': [{'id': 'CHS130-00215', 'type': 'OTHER', 'domain': 'Hebei Clinical Trail Committee'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Surgical flap', 'description': 'Dorsal digito-metacarpal flap is based on the dorsal digital artery and dorsal metacarpal artery.', 'interventionNames': ['Procedure: Dorsal digito-metacarpal flap']}], 'interventions': [{'name': 'Dorsal digito-metacarpal flap', 'type': 'PROCEDURE', 'description': 'The dorsal digito-metacarpal flap is a vascular island flap based on the dorsal digital artery and dorsal metacarpal artery. It has a longer vascular pedicle and provides tissue coverage of similar quality as that of normal glabrous skin but not sacrifice the digital artery.', 'armGroupLabels': ['Surgical flap']}]}, 'contactsLocationsModule': {'locations': [{'zip': '063000', 'city': 'Tangshan', 'state': 'Hebei', 'country': 'China', 'facility': 'The Second Hospital of Tangshan', 'geoPoint': {'lat': 39.64381, 'lon': 118.18319}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Second Hospital of Tangshan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}