Skip to main content
OpenTrials
Completed

NCT Number: NCT01707654

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Infection Wound Disruption of Nerve Repair Infections Wound Infection

Age range

16 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second Hospital of Tangshan

Tangshan, Hebei, 063000, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nerve flap

Device

Based on the Teoh et al.'s technique, we combined the nerve graft into the bipedicled heterodigital arterialized island flap and used this composite flap tissue for reconstructing complicated infected wound in the finger.

Primary outcomes

  1. 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

  1. Semmes-Weinstein (SW) Monofilament Test

    Time frame: 17-25 months

    The test points were at the center of the radial or ulnar portion of the pulp. The donor site, i.e. radial- or ulnar-dorsal aspect of the middle phalanx of the donor digit, was also evaluated.

Other outcomes

  1. Pain

    Time frame: 17-25 months

    Pain was given subjectively by the patient using the visual analogue scale (VAS). The VAS consists of a 10 cm line that was grouped into mild (1-3 cm), moderate (4-6 cm) and severe (7-10 cm).

Sponsors and collaborators

Lead sponsor

The Second Hospital of Tangshan

Other

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2012
First posted
Oct 16, 2012
Registry last updated
Nov 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.