- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01533337
Free Dorsal Digital Flap for Reconstruction of Volar Soft Tissue Defect of Digits
January 19, 2024 updated by: The Second Hospital of Tangshan
The aim of the current report is to investigate the feasibility of transferring the free dorsal digital flap, including both dorsal branches of the proper digital nerves (PDNs), to reconstruct the volar soft tissue defect of digits.
Sensory restoration of the reconstructed digit was evaluated via static two-point discrimination (2PD).
The range of motion (ROM) of the donor middle and ring fingers was measured.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Sensory restoration of the reconstructed digit was evaluated via static two-point discrimination (2PD).
The range of motion (ROM) of the donor middle and ring fingers was measured.
The data were compared with those of the contralateral, uninjured hand.
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
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
No
Description
Inclusion Criteria:
- soft tissue defects in the fingertip, pulp, or volar surface of the digits;
- a defect > 2 cm in length;
- unavailability of the homodigital and heterodigital island flaps because of concomitant injuries to donor fingers; and
- the patient refuses to use tissues from the toe.
Exclusion Criteria:
- soft tissue defects in the dorsum of the digits;
- a defect < 2 cm in length;
- homodigital and heterodigital island flaps are available.
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 |
---|---|
Other: finger
Free dorsal digital flap transferring is used for reconstruction of soft-tissue defects
|
The dorsal digital flap, including both dorsal branches of the proper digital nerves, was designed on the dorsum of the donor finger between the distal third of the proximal phalanx and the distal interphalangeal joint.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
static 2-point discrimination (2PD) test
Time Frame: 25 months
|
The test points were at the centers of the radial and ulnar portions of the digital pulp and the donor sites separately.
Each area was tested 3 times with a Dellon-Mackinnon discriminator.
Two out of 3 correct answers were considered proof of perception before proceeding to another lower value.
|
25 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
May 1, 2007
Primary Completion (Actual)
May 1, 2009
Study Completion (Actual)
October 1, 2011
Study Registration Dates
First Submitted
February 10, 2012
First Submitted That Met QC Criteria
February 14, 2012
First Posted (Estimated)
February 15, 2012
Study Record Updates
Last Update Posted (Actual)
January 22, 2024
Last Update Submitted That Met QC Criteria
January 19, 2024
Last Verified
February 1, 2012
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Tschen3886
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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