Nerve Injury Clinical Trial
Official title:
Free Dorsal Digital Flap for Reconstruction of Volar Soft Tissue Defect of Digits
NCT number | NCT01533337 |
Other study ID # | Tschen3886 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2007 |
Est. completion date | October 2011 |
Verified date | February 2012 |
Source | The Second Hospital of Tangshan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 12 |
Est. completion date | October 2011 |
Est. primary completion date | May 2009 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 15 Years to 60 Years |
Eligibility | Inclusion Criteria: 1. soft tissue defects in the fingertip, pulp, or volar surface of the digits; 2. a defect > 2 cm in length; 3. unavailability of the homodigital and heterodigital island flaps because of concomitant injuries to donor fingers; and 4. the patient refuses to use tissues from the toe. Exclusion Criteria: 1. soft tissue defects in the dorsum of the digits; 2. a defect < 2 cm in length; 3. homodigital and heterodigital island flaps are available. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
The Second Hospital of Tangshan | Chinese PLA General Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | static 2-point discrimination (2PD) test | 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 |
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