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:
Collaborator:
Chinese PLA General Hospital
Information provided by (Responsible Party):
The Second Hospital of Tangshan
ClinicalTrials.gov Identifier:
NCT01533337
First received: February 10, 2012
Last updated: February 14, 2012
Last verified: February 2012
  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: 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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   15 Years to 60 Years
Genders Eligible for Study:   Both
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
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No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: The Second Hospital of Tangshan
ClinicalTrials.gov Identifier: NCT01533337     History of Changes
Other Study ID Numbers: Tschen3886
Study First Received: February 10, 2012
Last Updated: February 14, 2012
Health Authority: China: Ethics Committee

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

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on August 28, 2014