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

NCT01629602 — Not applicable, Completed, 49 participants, The Second Hospital of Tangshan

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Registry	NCT01629602
Status	Completed
Phase	Not applicable
Study type	Interventional; na, single group, masking: single, treatment
Enrollment	49 (Actual)
Sponsor	The Second Hospital of Tangshan (Other); collaborators: Chinese PLA General Hospital
Conditions	Soft Tissue Loss With Nerve Defect
Interventions	the Boomerang Nerve Flap (Procedure)
Dates	start 2008-07-01, primary completion 2010-05-01, completion 2011-06-01, first posted 2012-06-27, last updated 2012-06-27

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
vascularized nerve graft	Experimental	Procedure: 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.

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.

+Outcome measures

Primary outcomes

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 outcomes

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).

+Eligibility

Sex: All, ages: 16 Years to 50 Years

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.

+Publications

Results publication: 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