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

Infection Wound Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01707654
• Other study ID #: TSChen6017
• Secondary ID: HEBEI-J06451
• Status: Completed
• Phase: N/A
• Start date: July 2008
• Est. completion date: February 2012

Study information

• Verified date: April 2012
• Source: The Second Hospital of Tangshan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: February 2012
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Disruption of Nerve Repair
• Infection Wound
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
China	The Second Hospital of Tangshan	Tangshan	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
The Second Hospital of Tangshan

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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