- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01778296
Repair of Soft Tissue Defect of the Finger Using the Heterodigital Neurocutaneous Island Flap
January 19, 2024 updated by: The Second Hospital of Tangshan
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 digital island flap can be used for repairing the defect of adjacent finger, but the limited length of the pedicle precludes its use for a more distal defect.
The heterodigital neurocutaneous island flap of the dorsal branch of the digital nerve can be used as an alternative to resolve this problem.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
At final follow-up, we measured the sensibility of the flaps using the Semmes-Weinstein monofilament test and the static 2-point discrimination test.
The test points were at the center of the radial or ulnar portion of the pulp.
The donor site, i.e. radial- or ulnar-dorsal aspect of the middle phalanx of the donor digit, was also evaluated.
Each area was tested 3 times with a Discriminator (Ali Med, Dedham, MA).
We stopped at 4mm as a limit of 2PD and considered this normal.
Study Type
Interventional
Enrollment (Actual)
12
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 60 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- the soft tissue defects involving the middle phalanx, the proximal interphalangeal joint, or both;
- a defect greater than or equal to 2 cm in length;
- a patient between 15 and 60 years of age.
Exclusion Criteria:
- concomitant injuries to the dorsal skin of the middle phalanx of adjacent finger that precluded its use as donor site;
- injuries to the course of donor nerve branch;
- a defect less than 1.5 cm in length;
- a fingertip or pulp defect;
- 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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Surgical flap
The neurocutaneous island flap is based on the dorsal branch of the digital nerve
|
The neurocutaneous island flap of the dorsal branch of the digital nerve can be used for repair the defects of the proximal and middle phalanxes of adjacent fingers.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Discriminatory Sensation of the Flap
Time Frame: 18 months to 24 months
|
Discriminatory sensation of the flap is evaluated with the Static 2-point Discrimination Test.
The test determines the minimal distance at which a subject can sense the presence of two needles.
The modified American Society for Surgery of the Hand guidelines were used to stratify Discriminator measurements (excellent <6 mm; good 6-10 mm; fair 11-15 mm; poor >15 mm.
The test point is at the center of the flap.
Each area was tested 3 times with a Discriminator (Ali Med, Dedham, MA).
Two out of 3 correct answers were considered proof of perception before proceeding to another lower value.
We stop at 4mm as a limit of 2PD and considered this normal.
These assessments take place at a single time point at the final follow-up.
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18 months to 24 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cold Intolerance
Time Frame: 18 months to 24 months
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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).
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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, Zhang X, Shao X, Gao S, Wang B, Liu D. Treatment of a combination of volar soft tissue and proper digital nerve defects using the dorsal digital nerve island flap. J Hand Surg Am. 2010 Oct;35(10):1655-1662.e3. doi: 10.1016/j.jhsa.2010.07.011.
- Wang B, Zhao Y, Lu A, Chen C. Ulnar nerve deep branch compression by a ganglion: a review of nine cases. Injury. 2014 Jul;45(7):1126-30. doi: 10.1016/j.injury.2014.03.017. Epub 2014 Apr 3.
- Chen C, Tang P, Zhang L. Reconstruction of a soft tissue defect in the finger using the heterodigital neurocutaneous island flap. Injury. 2013 Nov;44(11):1607-14. doi: 10.1016/j.injury.2013.06.025. Epub 2013 Jul 18.
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, 2008
Primary Completion (Actual)
March 1, 2012
Study Completion (Actual)
October 1, 2012
Study Registration Dates
First Submitted
January 25, 2013
First Submitted That Met QC Criteria
January 28, 2013
First Posted (Estimated)
January 29, 2013
Study Record Updates
Last Update Posted (Actual)
February 14, 2024
Last Update Submitted That Met QC Criteria
January 19, 2024
Last Verified
May 1, 2012
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- HBTS1301283
- CHS1301-00146 (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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