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Completed

NCT Number: NCT01629602

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

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.

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Key information

Conditions

Soft Tissue Loss With Nerve Defect

Age range

16 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

the Boomerang Nerve Flap

Procedure

The nerve branch was combined with the boomerang flap for simultaneous repair of soft tissue loss and PDN defect in these awkward areas.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

The Second Hospital of Tangshan

Other

Collaborators

  • Chinese PLA General Hospital

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
Jun 27, 2012
Registry last updated
Jun 27, 2012

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.