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: August 18, 2013
Last verified: April 2012

October 12, 2012
August 18, 2013
July 2008
May 2010   (final data collection date for primary outcome measure)
2-point Discrimination Test [ Time Frame: 17-25 months ] [ Designated as safety issue: No ]
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.
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.
Complete list of historical versions of study NCT01707654 on ClinicalTrials.gov Archive Site
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.
Same as current
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).
Same as current
 
Repair of Infective Wound Associated With Nerve Defect in the Finger Using A Bipedicled Nerve Flap
Not Provided

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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Infection Wound
  • Disruption of Nerve Repair
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.
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.
Intervention: Device: Nerve flap

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
9
February 2012
May 2010   (final data collection date for primary outcome measure)

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.
Both
16 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01707654
TSChen6017, HEBEI-J06451
Not Provided
The Second Hospital of Tangshan
The Second Hospital of Tangshan
Not Provided
Not Provided
The Second Hospital of Tangshan
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP