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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01707654
Recruitment Status : Completed
First Posted : October 16, 2012
Results First Posted : October 23, 2013
Last Update Posted : October 23, 2013
Information provided by (Responsible Party):
The Second Hospital of Tangshan

Brief Summary:
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 or disease Intervention/treatment Phase
Infection Wound Disruption of Nerve Repair Device: Nerve flap Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : July 2008
Actual Primary Completion Date : May 2010
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 2-point Discrimination Test [ Time Frame: 17-25 months ]
    The 2-point Discrimination Test determines the minimal distance at which a subject can sense the presence of two needles. The modified American Society for Surgery of the Hand guidelines were used to stratify Discriminator measurements (excellent <6 mm; good 6-10 mm; fair 11-15 mm; poor >15 mm. 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). Two out of 3 correct answers were considered proof of perception before proceeding to another lower value. We stopped at 4 mm as a limit of 2PD and considered this normal. The assessments were performed at a single time point at the final follow up.

Secondary Outcome Measures :
  1. Semmes-Weinstein (SW) Monofilament Test [ Time Frame: 17-25 months ]
    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:
  1. Pain [ Time Frame: 17-25 months ]
    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).

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Ages Eligible for Study:   16 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01707654

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

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: The Second Hospital of Tangshan Identifier: NCT01707654     History of Changes
Other Study ID Numbers: TSChen6017
HEBEI-J06451 ( Other Identifier: Hebei Ethics Committee )
First Posted: October 16, 2012    Key Record Dates
Results First Posted: October 23, 2013
Last Update Posted: October 23, 2013
Last Verified: April 2012

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