Free Dorsal Digital Flap for Reconstruction of Volar Soft Tissue Defect of Digits

January 19, 2024 updated by: The Second Hospital of Tangshan
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.

Study Overview

Status

Completed

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: finger
Free dorsal digital flap transferring is used for reconstruction of soft-tissue defects
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
25 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

February 10, 2012

First Submitted That Met QC Criteria

February 14, 2012

First Posted (Estimated)

February 15, 2012

Study Record Updates

Last Update Posted (Actual)

January 22, 2024

Last Update Submitted That Met QC Criteria

January 19, 2024

Last Verified

February 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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