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

History of Changes

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:

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 (Child, Adult)
Genders Eligible for Study:	Both
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.

Contacts and Locations

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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
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

ClinicalTrials.gov processed this record on September 28, 2016

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