Repair of Infective Wound Associated With Nerve Defect in the Finger Using A Bipedicled Nerve Flap
|ClinicalTrials.gov Identifier: NCT01707654|
Recruitment Status : Completed
First Posted : October 16, 2012
Results First Posted : October 23, 2013
Last Update Posted : October 23, 2013
|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|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||May 2010|
|Actual Study Completion Date :||February 2012|
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.
- 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.
- 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.
- 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01707654
|The Second Hospital of Tangshan|
|Tangshan, Hebei, China, 063000|