Treatment of Soft Tissue Loss With Nerve Defect in the Finger Using the Boomerang Nerve Flap

June 26, 2012 updated by: The Second Hospital of Tangshan
Soft tissue loss with proper digital nerve (PDN) defect in the finger results in sensory loss of the finger pulp. Reconstruction of these complex soft tissue defects continues to be a challenge problem. To resolve this problem, we combined the nerve branch with the boomerang flap for simultaneous repair of soft tissue loss and PDN defect in these awkward areas. For comparison, we also collected a consecutive series of 32 patients with similar injury in the finger treated using a cross finger flap and a secondary free nerve graft.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The patients in this study group were required to meet all of the following criteria: soft tissue loss between the midpoint of the distal phalanx and PIP joint; associated PDN defect 1 to 4 cm in length; single or double PDN defects; and simultaneous repair of soft tissue loss and PDN defect. Patients were excluded when they had the following: injury to the course of the vascular pedicle or the donor site or the donor nerve; PDN defect less than 1 cm or larger than 4 cm in length; direct PDN repair; and thumb neurocutaneous defects.

Study Type

Interventional

Enrollment (Actual)

49

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

16 years to 50 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • soft tissue loss between the midpoint of the distal phalanx and PIP joint; - associated PDN defect 1 to 4 cm in length;
  • single or double PDN defects;
  • simultaneous repair of soft tissue loss and PDN defect.

Exclusion Criteria:

  • injury to the course of the vascular pedicle or the donor nerve;
  • PDN defect less than 1 cm or larger than 4 cm in length;
  • direct PDN repair;
  • thumb neurocutaneous defects.

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: vascularized nerve graft
The investigators combined the nerve branch with the boomerang flap for simultaneous repair of soft tissue loss and PDN defect in these awkward areas.
Procedure: the Boomerang Nerve Flap
The nerve branch was combined with the boomerang flap for simultaneous repair of soft tissue loss and PDN defect in these awkward areas.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
static 2-point discrimination test
Time Frame: from 18 to 24 months
The test points were at the centers of the radial and ulnar portions of the finger pulp, the flap and the donor sites separately.
from 18 to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cold Intolerance Severity Score (CISS) questionnaire
Time Frame: from 18 to 24 months
The maximum score was 100 and was grouped into mild (0-25), moderate (26-50), severe (51-75) and extreme severity (76-100).
from 18 to 24 months

Collaborators and Investigators

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

Sponsor

The Second Hospital of Tangshan

Collaborators

Chinese PLA General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

July 1, 2008

Primary Completion (ACTUAL)

May 1, 2010

Study Completion (ACTUAL)

June 1, 2011

Study Registration Dates

First Submitted

June 22, 2012

First Submitted That Met QC Criteria

June 26, 2012

First Posted (ESTIMATE)

June 27, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

June 27, 2012

Last Update Submitted That Met QC Criteria

June 26, 2012

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TSChen4112

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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