Use of the Free Dorsal Digital Flap Including Both Dorsal Branches of the Proper Digital Nerves for Reconstruction of Volar Soft Tissue Defect of Digits
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ClinicalTrials.gov Identifier: NCT01533337 |
Recruitment Status
:
Completed
First Posted
: February 15, 2012
Last Update Posted
: February 15, 2012
|
Sponsor:
The Second Hospital of Tangshan
Collaborator:
Chinese PLA General Hospital
Information provided by (Responsible Party):
The Second Hospital of Tangshan
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Brief Summary:
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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Nerve Injury Digital Pulp Defect | Procedure: Free dorsal digital flap | Not Applicable |
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 (Clinical Trial) |
Actual Enrollment : | 12 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Study Start Date : | May 2007 |
Actual Primary Completion Date : | May 2009 |
Actual Study Completion Date : | October 2011 |
Intervention Details:
-
Procedure: Free dorsal digital flap
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.
Primary Outcome Measures
:
- 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.
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Ages Eligible for Study: | 15 Years to 60 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Criteria
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.
No Contacts or Locations Provided
Responsible Party: | The Second Hospital of Tangshan |
ClinicalTrials.gov Identifier: | NCT01533337 History of Changes |
Other Study ID Numbers: |
Tschen3886 |
First Posted: | February 15, 2012 Key Record Dates |
Last Update Posted: | February 15, 2012 |
Last Verified: | February 2012 |
Keywords provided by The Second Hospital of Tangshan:
dorsal digital free flap dorsal branch of proper digital nerve dorsal branch of proper digital artery proper digital artery |