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Clinical Trials/NCT01707654
NCT01707654
Completed
Not Applicable

Repair of Infective Wound Associated With Nerve Defect in the Finger Using A Bipedicled Nerve Flap

The Second Hospital of Tangshan1 site in 1 country9 target enrollmentJuly 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Infection Wound
Sponsor
The Second Hospital of Tangshan
Enrollment
9
Locations
1
Primary Endpoint
2-point Discrimination Test
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

A combination of soft tissue and digital nerve defects in the finger results in sensory loss of the finger pulp. Reconstruction of these combined injuries is difficult. When the neurocutaneous defect is associated with wound infection, reconstructive alternatives are more limited. From July 2008 to May 2010, a retrospective study was conducted with 9 consecutive postinfection patients who had the neurocutaneous defect of the finger following trauma. The purpose of this retrospective study is to report repair of the complicated infected wound in the finger using the bipedicled nerve flap and to evaluate the efficacy of this technique.

Detailed Description

sensation of the flaps is assessed using static two-point discrimination (2PD) and Semmes-Weinstein monofilament (SWM) testing at final follow-up. The cold intolerance of the injured finger is measured using the self-administered Cold Intolerance Severity Score questionnaire that was rated into mild, moderate, severe, and extreme (0-25, 26-50, 51-75 and 76-100). Patients report their satisfaction with functional recovery of the injured finger according to the Michigan Hand Outcomes Questionnaire that was based on a 5-point response scale.

Registry
clinicaltrials.gov
Start Date
July 2008
End Date
February 2012
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • an infective wound with exposed bone or tendon in the finger;
  • soft tissue defect involving proximal half of the middle phalanx, the proximal phalanx, or both;
  • associated digital nerve defect 1 to 4 cm in length;
  • single or double nerve defects; and
  • simultaneous repair of nerve and soft tissue defects.

Exclusion Criteria

  • injury to the course of the pedicle or the donor site;
  • nerve defect less than 1 cm or larger than 4 cm in length;
  • occurrence of the defect in a region the flap is unable to reach, such as distal interphalangeal joint region, distal portion of the middle phalanx of the middle finger and the thumb;
  • no involvement of the digital nerve.

Outcomes

Primary Outcomes

2-point Discrimination Test

Time Frame: 17-25 months

The 2-point Discrimination Test determines the minimal distance at which a subject can sense the presence of two needles. The modified American Society for Surgery of the Hand guidelines were used to stratify Discriminator measurements (excellent \<6 mm; good 6-10 mm; fair 11-15 mm; poor \>15 mm. The test points were at the center of the radial or ulnar portion of the pulp. Each area was tested 3 times with a Discriminator (Ali Med, Dedham, MA). Two out of 3 correct answers were considered proof of perception before proceeding to another lower value. We stopped at 4 mm as a limit of 2PD and considered this normal. The assessments were performed at a single time point at the final follow up.

Secondary Outcomes

  • Semmes-Weinstein (SW) Monofilament Test(17-25 months)

Study Sites (1)

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