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

Not Applicable

Completed

• Conditions: Soft Tissue Loss With Nerve Defect
• Interventions: Procedure: the Boomerang Nerve Flap

• Registration Number: NCT01629602
• Lead Sponsor: The Second Hospital of Tangshan

Brief Summary

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.

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 Timeline

• Study Start: 2008-07
• Primary Completion: 2010-05
• Status Verified: 2011-05
• Study Completion: 2011-06
• Study First Submitted: 2012-06-22
• Study First Submitted QC: 2012-06-26
• Last Update Submitted: 2012-06-26
• Study First Posted: 2012-06-27
• Last Update Posted: 2012-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
vascularized nerve graft	the Boomerang Nerve Flap	The investigators combined the nerve branch with the boomerang flap for simultaneous repair of soft tissue loss and PDN defect in these awkward areas.

Primary Outcome Measures

Name	Time	Method
static 2-point discrimination test	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 Outcome Measures

Name	Time	Method
Cold Intolerance Severity Score (CISS) questionnaire	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).