Clinical trial NCT01707654: Repair of Infective Wound Associated With Nerve Defect in the Finger Using A Bipedicled Nerve Flap
Official title: Repair of Infective Wound Associated With Nerve Defect in the Finger Using A Bipedicled Nerve Flap
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infection Wound
Disruption of Nerve Repair
Keywords: defect;
dorsal branch of the proper digital nerve;
proper digital nerve;
finger sensory reconstruction.
Lead sponsor: The Second Hospital of Tangshan
Sponsor class: OTHER
First posted: 2012-10-16
Enrollment: 9
Sex: ALL
Minimum age (years): 16
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: sensation of the flaps is assessed using static two-point discrimination (2PD) and Semmes-Weinstein monofilament (SWM) testing at final follow-up. The cold intolerance of the injured finger is measured using the self-administered Cold Intolerance Severity Score questionnaire that was rated into mild, moderate, severe, and extreme (0-25, 26-50, 51-75 and 76-100). Patients report their satisfaction with functional recovery of the injured finger according to the Michigan Hand Outcomes Questionnaire that was based on a 5-point response scale.

Eligibility 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.

Primary outcomes:
measure: 2-point Discrimination Test
timeFrame: 17-25 months
Secondary outcomes:
measure: Semmes-Weinstein (SW) Monofilament Test
timeFrame: 17-25 months
Other outcomes:
measure: Pain
timeFrame: 17-25 months
Locations:
city: Tangshan
country: China
facility: The Second Hospital of Tangshan
state: Hebei
Study officials:
References:
citation: Chen C, Zhang X, Shao X, Gao S, Wang B, Liu D. Treatment of a combination of volar soft tissue and proper digital nerve defects using the dorsal digital nerve island flap. J Hand Surg Am. 2010 Oct;35(10):1655-1662.e3. doi: 10.1016/j.jhsa.2010.07.011.
citation: Chen C, Tang P, Zhang L. Use of a bipedicled nerve flap taken from the dorsum of the digit for reconstruction of neurocutaneous defect in the adjacent finger. J Plast Reconstr Aesthet Surg. 2013 Oct;66(10):1322-9. doi: 10.1016/j.bjps.2013.06.001. Epub 2013 Jul 2.