Bilaterally Innervated Sensory Dorsal Digital Flaps for Sensory Reconstruction of the Fingers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2013-08-31

Brief Summary

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Sensory coverage in the finger continues to be a challenging problem. This study reports sensory reconstruction of the fingers with the bilaterally innervated dorsal digital flaps and compares the results between the dual- and single-innervated flaps.The main evaluated outcomes are static 2-point discrimination and Semmes-Weinstein monofilament scores of the flap, fingertip pain and joint motion.

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Detailed Description

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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 (0-3 cm), moderate (4-6 cm) and severe (7-10 cm). Tinel's sign was rated as the following: grade 1=none; grade 2=mild, slight tingle; grade 3=moderate, very uncomfortable; and grade 4=severe, patient unable to use hand because of any stimulation of the neuroma.

Conditions

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Soft Tissue Injuries

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bilaterally innervated flap

Two nerve branches attached with the flap for sensory reconstruction.

Group Type OTHER

Flap including bilateral nerve branches

Intervention Type PROCEDURE

Two nerve branches are attached with the flap for sensory coverage

Interventions

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Flap including bilateral nerve branches

Two nerve branches are attached with the flap for sensory coverage

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* a soft-tissue defect in the areas where sensory return was considered important ●a defect with exposed bone or tendon in one finger
* the defect associated with the transected digital nerves in both sides
* a defect greater than 1.5 cm
* a patient aged 15 to 60 years

Exclusion Criteria

* injuries to the dorsum of the finger or to the course of the vascular pedicle that precluded its use as the donor
* injuries to the dorsal branches of the digital nerves that precluded its use as donor nerves attached with the flap
* a defect less than or equal to 1.5 cm
* patient age \< 15 years or \> 60 years

Minimum Eligible Age

15 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes