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

This study has been completed.
Sponsor:
Collaborator:
Chinese PLA General Hospital
Information provided by (Responsible Party):
The Second Hospital of Tangshan
ClinicalTrials.gov Identifier:
NCT01629602
First received: June 22, 2012
Last updated: June 26, 2012
Last verified: May 2011
  Purpose

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.


Condition Intervention
Soft Tissue Loss With Nerve Defect
Procedure: the Boomerang Nerve Flap

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Further study details as provided by The Second Hospital of Tangshan:

Primary Outcome Measures:
  • static 2-point discrimination test [ Time Frame: from 18 to 24 months ] [ Designated as safety issue: No ]
    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:
  • Cold Intolerance Severity Score (CISS) questionnaire [ Time Frame: from 18 to 24 months ] [ Designated as safety issue: No ]
    The maximum score was 100 and was grouped into mild (0-25), moderate (26-50), severe (51-75) and extreme severity (76-100).


Enrollment: 49
Study Start Date: July 2008
Study Completion Date: June 2011
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: vascularized nerve graft
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
The nerve branch was combined with the boomerang flap for simultaneous repair of soft tissue loss and PDN defect in these awkward areas.

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.

  Eligibility

Ages Eligible for Study:   16 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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No Contacts or Locations Provided
  More Information

No publications provided by The Second Hospital of Tangshan

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: The Second Hospital of Tangshan
ClinicalTrials.gov Identifier: NCT01629602     History of Changes
Other Study ID Numbers: TSChen4112
Study First Received: June 22, 2012
Last Updated: June 26, 2012
Health Authority: China: Ethics Committee

Keywords provided by The Second Hospital of Tangshan:
defect;
dorsal branch of the proper digital nerve;
proper digital nerve;
vascularized nerve graft

ClinicalTrials.gov processed this record on July 24, 2014