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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01533337
First Posted: February 15, 2012
Last Update Posted: February 15, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Chinese PLA General Hospital
Information provided by (Responsible Party):
The Second Hospital of Tangshan
  Purpose
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 Intervention
Nerve Injury Digital Pulp Defect Procedure: Free dorsal digital flap

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Further study details as provided by The Second Hospital of Tangshan:

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.


Enrollment: 12
Study Start Date: May 2007
Study Completion Date: October 2011
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
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.
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.
  Eligibility

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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:

  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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: The Second Hospital of Tangshan
ClinicalTrials.gov Identifier: NCT01533337     History of Changes
Other Study ID Numbers: Tschen3886
First Submitted: February 10, 2012
First Posted: February 15, 2012
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