A Comparison of Dorsal Branch of the Digital Nerve Versus Dorsal Digital Nerve for Finger Pulp Reconstruction

Not Applicable

Completed

• Conditions: Soft Tissue Defect of the Finger
• Interventions: Procedure: flap includes a donor nerve

• Registration Number: NCT01826539
• Lead Sponsor: The Second Hospital of Tangshan

Brief Summary

As the donor nerve attached with the flap, the dorsal branch of the digital nerve and the dorsal digital nerve is commonly used for finger pulp reconstruction.This study compares two donor nerves: the dorsal branch of the digital nerve and the dorsal digital nerve.

Detailed Description

The investigators compares two donor nerves attached with the flap for sensory reconstruction of finger pulp: the dorsal branch of the digital nerve and the dorsal digital nerve. The main outcomes were static 2-point discrimination and Semmes-Weinstein monofilament scores of the flap, and pain and cold intorlence of the reconstructed finger.

Study Timeline

• Study Start: 2011-01
• Status Verified: 2011-04
• Primary Completion: 2012-02
• Study Completion: 2012-09
• Study First Submitted: 2013-04-01
• Study First Submitted QC: 2013-04-05
• Last Update Submitted: 2013-04-05
• Study First Posted: 2013-04-08
• Last Update Posted: 2013-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

• The pulp or fingertip defect in only one finger
• A defect greater than or equal to 1.5 cm in length
• Necessity to preserve finger length
• A patient between 18 and 60 years of age

Exclusion Criteria

• Injuries to the dorsum of the middle phalanx
• Injuries to the course of the vascular pedicle or donor nerve
• A defect less than 1.5 cm in length
• Multiple finger pulp defect
• Extremely contaminated wounds

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Innervated finger flap	flap includes a donor nerve	donor nerve attached with the flap for finger pulp reconstruction

Primary Outcome Measures

Name	Time	Method
static 2-point discrimination (2PD) test	18 months to 26 months	The test points are at the center of the radial or ulnar portion of the pulp. Each area is tested 3 times with a Discriminator. We stop at 4mm as a limit of 2PD and consider this normal.

Secondary Outcome Measures

Name	Time	Method
Cold intolerance	18 months to 26 months	Cold intolerance in the reconstructed finger is assessed using the self-administered Cold Intolerance Severity Score questionnaire \[10\]. The maximum score is 100 and was group into 4 ranges (0-25, 26-50, 51-75, and 76-100), corresponding to mild, moderate, severe, and extreme severity, respectively.

Trial Locations

Locations (1)

The Second Hospital of Tangshan; 🇨🇳 Tangshan, Hebei, China