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Repair of Infective Wound Associated With Nerve Defect in the Finger Using A Bipedicled Nerve Flap

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
The Second Hospital of Tangshan
ClinicalTrials.gov Identifier:
NCT01707654
First received: October 12, 2012
Last updated: October 15, 2012
Last verified: April 2012
History of Changes
  Purpose

A combination of soft tissue and digital nerve defects in the finger results in sensory loss of the finger pulp. Reconstruction of these combined injuries is difficult. When the neurocutaneous defect is associated with wound infection, reconstructive alternatives are more limited. From July 2008 to May 2010, a retrospective study was conducted with 9 consecutive postinfection patients who had the neurocutaneous defect of the finger following trauma. The purpose of this retrospective study is to report repair of the complicated infected wound in the finger using the bipedicled nerve flap and to evaluate the efficacy of this technique.


Condition Intervention
Infection Wound
Disruption of Nerve Repair
 Device: Nerve flap

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

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

Primary Outcome Measures:
  • 2-point discrimination test [ Time Frame: 17-25 months ] [ Designated as safety issue: No ]
    The test points were at the center of the radial or ulnar portion of the pulp. Each area was tested 3 times with a Discriminator (Ali Med, Dedham, MA). We stopped at 4mm as a limit of 2PD and considered this normal.


Secondary Outcome Measures:
  • Semmes-Weinstein (SW) monofilament test [ Time Frame: 17-25 months ] [ Designated as safety issue: No ]
    The test points were at the center of the radial or ulnar portion of the pulp. The donor site, i.e. radial- or ulnar-dorsal aspect of the middle phalanx of the donor digit, was also evaluated.


Other Outcome Measures:
  • Pain [ Time Frame: 17-25 months ] [ Designated as safety issue: No ]
    Pain was given subjectively by the patient using the visual analogue scale (VAS). The VAS consists of a 10 cm line that was grouped into mild (1-3 cm), moderate (4-6 cm) and severe (7-10 cm).


Enrollment: 9
Study Start Date: July 2008
Study Completion Date: February 2012
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
nerve graft
Simultaneous repair of the infected wound and digital nerve defect in the finger using a bipedicled nerve flap including nerve graft from the dorsal branch of the digital nerve.
 Device: Nerve flap
Based on the Teoh et al.'s technique, we combined the nerve graft into the bipedicled heterodigital arterialized island flap and used this composite flap tissue for reconstructing complicated infected wound in the finger.

  Eligibility

Ages Eligible for Study:   16 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • an infective wound with exposed bone or tendon in the finger;
  • soft tissue defect involving proximal half of the middle phalanx, the proximal phalanx, or both;
  • associated digital nerve defect 1 to 4 cm in length;
  • single or double nerve defects; and
  • simultaneous repair of nerve and soft tissue defects.

Exclusion Criteria:

  • injury to the course of the pedicle or the donor site;
  • nerve defect less than 1 cm or larger than 4 cm in length;
  • occurrence of the defect in a region the flap is unable to reach, such as distal interphalangeal joint region, distal portion of the middle phalanx of the middle finger and the thumb;
  • no involvement of the digital nerve.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01707654

Locations
China, Hebei
The Second Hospital of Tangshan
Tangshan, Hebei, China, 063000
Sponsors and Collaborators
The Second Hospital of Tangshan
  More Information

Publications:

Responsible Party: The Second Hospital of Tangshan
ClinicalTrials.gov Identifier: NCT01707654     History of Changes
Other Study ID Numbers: TSChen6017, HEBEI-J06451
Study First Received: October 12, 2012
Last Updated: October 15, 2012
Health Authority: United States: Food and Drug Administration
China: Ethics Committee

Keywords provided by The Second Hospital of Tangshan:
defect;
dorsal branch of the proper digital nerve;
proper digital nerve;
finger sensory reconstruction.

ClinicalTrials.gov processed this record on May 19, 2013