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

NCT01629602 | Completed

• 1 other identifier: TSChen4112
• Study Type: interventional
• Target: 49
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Soft Tissue Loss With Nerve Defect

Keywords

defect;; dorsal branch of the proper digital nerve;; proper digital nerve;; vascularized nerve graft

Outcome Measures

Primary Outcomes (1)

• static 2-point discrimination test

  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 Outcomes (1)

• Cold Intolerance Severity Score (CISS) questionnaire

  from 18 to 24 months

Study Arms (1)

vascularized nerve graft

EXPERIMENTAL

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

Interventions

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.

vascularized nerve graft

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Second Hospital of Tangshan: lead
• Chinese PLA General Hospital: collaborator

Related Publications (1)

• Chen C, Tang P, Zhang X. Treatment of soft-tissue loss with nerve defect in the finger using the boomerang nerve flap. Plast Reconstr Surg. 2013 Jan;131(1):44e-54e. doi: 10.1097/PRS.0b013e3182729f5e.

  PMID: 23271553 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2012
• First Posted: June 27, 2012
• Study Start: July 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: June 1, 2011
• Last Updated: June 27, 2012

Record last verified: 2011-05