- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01927003
Direct and Reversed Dorsal Digito-metacarpal Flaps: A Review of 24 Cases
October 25, 2018 updated by: The Second Hospital of Tangshan
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hebei
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Tangshan, Hebei, China, 063000
- The Second Hospital of Tangshan
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 55 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- the injured and adjacent fingers are unable to be used as the donor due to multiple digital injuries
- a soft tissue defect > 1.5 cm in length with exposed bone or tendon
- 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
- a patient between 15 and 60 years of age
Exclusion Criteria:
- concomitant injuries involved all the finger that precluded their use as donor sites
- a defect less than 1.5 cm in length
- injuries to the course of the vascular pedicle
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Surgical flap
Dorsal digito-metacarpal flap is based on the dorsal digital artery and dorsal metacarpal artery.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Static 2-point discrimination test
Time Frame: 18 to 24months
|
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.
|
18 to 24months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient satisfaction
Time Frame: 18 to 24 months
|
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.
|
18 to 24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2009
Primary Completion (Actual)
September 1, 2011
Study Completion (Actual)
September 1, 2012
Study Registration Dates
First Submitted
August 19, 2013
First Submitted That Met QC Criteria
August 19, 2013
First Posted (Estimate)
August 21, 2013
Study Record Updates
Last Update Posted (Actual)
October 29, 2018
Last Update Submitted That Met QC Criteria
October 25, 2018
Last Verified
April 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HBTS1308112
- CHS130-00215 (Other Identifier: Hebei Clinical Trail Committee)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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