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

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.

Study Overview

• Status: Completed
• Conditions: Infection Wound; Disruption of Nerve Repair
• Intervention / Treatment: Device: Nerve flap

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.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hebei
    • Tangshan, Hebei, China, 063000
      • The Second Hospital of Tangshan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 55 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
2-point Discrimination Test	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.	17-25 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Semmes-Weinstein (SW) Monofilament Test	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.	17-25 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain	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).	17-25 months

Collaborators and Investigators

• Sponsor: The Second Hospital of Tangshan

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (ACTUAL): May 1, 2010
• Study Completion (ACTUAL): February 1, 2012

Study Registration Dates

• First Submitted: October 12, 2012
• First Submitted That Met QC Criteria: October 15, 2012
• First Posted (ESTIMATE): October 16, 2012

Study Record Updates

• Last Update Posted (ACTUAL): November 21, 2018
• Last Update Submitted That Met QC Criteria: October 25, 2018
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: defect;; dorsal branch of the proper digital nerve;; proper digital nerve;; finger sensory reconstruction.
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: TSChen6017; HEBEI-J06451 (OTHER: Hebei Ethics Committee)