- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01871103
The Dorsal Homodigital Island Flap Based on the Dorsal Branch of the Digital Artery: A Review of 171 Cases
June 5, 2013 updated by: The Second Hospital of Tangshan
Soft tissue reconstruction in the finger continues to evolve.
The dorsum of the finger is a reliable flap donor site in reconstructive hand surgery because of its similar quality to the original.
The dorsal homodigital island flap can be used as a reliable alternative for reconstructing small to moderate defects of the fingers.
In this retrospective study, the investigators would evaluate the efficacy of the technique for tissue reconstruction in different regions of the finger, with an emphasis on sensibility, pain and donor site morbidity.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
At final follow-up, sensory restoration of the flap is measured using the static 2-point discrimination test and Semmes-Weinstein monofilament test.
We evaluate pain sensations of the reconstructed fingers and donor sites with a visual analog scale.
The system consist of a 10 cm line that is grouped into mild (0-3 cm), moderate (4-6 cm) and severe (7-10 cm).
Active motion of the joints is measured using a goniometer.
The motion arcs of the reconstructed fingers are compared with the opposite side.
Study Type
Interventional
Enrollment (Actual)
173
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
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- the soft tissue defect in one finger or in multiple fingers
- a defect > 1.5 cm and < 3 cm in length
- necessity to preserve finger length
- a patient between 15 and 60 years of age
Exclusion Criteria:
- injuries to the dorsum of the finger or to the course of the vascular pedicle that precluded its use as the donor
- a defect≤1.5 cm or ≥3 cm in length
- a soft tissue defect of the thumb
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Surgical flap
The dorsal homodigital island flap is a perforator type flap based on the DB, which uses the dorsal skin of the injured finger to provide soft tissue coverage for a volar defect.
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The dorsal homodigital island flap is used for tissue reconstruction in different regions of the finger.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Static 2-point discrimination test
Time Frame: 18 months to 24 months
|
The test point is at the center of the flap.
Each area was tested 3 times with a Discriminator (Ali Med, Dedham, MA).
We stop at 4mm as a limit of 2PD and considered this normal.
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18 months to 24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cold intolerance
Time Frame: 18 months to 24 months
|
We access the cold intolerance of the injured and donor fingers using the self-administered Cold Intolerance Severity Score questionnaire10 that is rated into mild, moderate, severe, and extreme (0-25, 26-50, 51-75 and 76-100).
|
18 months to 24 months
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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
- Chen C, Tang P, Zhang X. Sensory reconstruction of a finger pulp defect using a dorsal homodigital island flap. Plast Reconstr Surg. 2012 Nov;130(5):1077-1086. doi: 10.1097/PRS.0b013e318267ef99.
- Chen C, Tang P, Zhang X. The dorsal homodigital island flap based on the dorsal branch of the digital artery: a review of 166 cases. Plast Reconstr Surg. 2014 Apr;133(4):519e-529e. doi: 10.1097/PRS.0000000000000016.
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
January 1, 2006
Primary Completion (Actual)
January 1, 2009
Study Completion (Actual)
March 1, 2013
Study Registration Dates
First Submitted
June 3, 2013
First Submitted That Met QC Criteria
June 5, 2013
First Posted (Estimate)
June 6, 2013
Study Record Updates
Last Update Posted (Estimate)
June 6, 2013
Last Update Submitted That Met QC Criteria
June 5, 2013
Last Verified
January 1, 2007
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- HBTS1306017
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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