Sensory Reconstruction of the Digits

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

151 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2015-10-31

Brief Summary

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A retrospective study is conducted with 151 patients who has a soft tissue defect of digit treated with the sensate flaps from February 2005 to March 2014. Based on the different regions of soft tissue defects, the patients in the study are divided into four groups: (1) thumb group treated with the bilaterally innervated and traditional kite flaps; (2) distal finger group treated with the single- and dual-innervated dorsal digital flaps; (3) proximal finger group treated with heterodigital neurocutaneous island flap; and (4) awkward region group treated with Litter flap. The main outcomes are static 2-point discrimination and Semmes-Weinstein monofilament scores of the flap, and pain and patient satisfaction.

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Detailed Description

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At final follow-up, sensory restoration of the flap is measured using the static 2PD test and Semmes-Weinstein monofilament test. Using the visual analogue scale (VAS) that consists of a 10 cm line, patients are asked to report pain sensations of the recipient site. Patients report their satisfaction with functional recovery of the injured finger according to the Michigan Hand Outcomes Questionnaire that is based on a 5-point response scale.

Conditions

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Soft Tissue Defect of Digit

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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sensate flap

the donor nerve harvested with the flap

Group Type OTHER

innervated sensate flap

Intervention Type PROCEDURE

sensory reconstruction via digital nerve repair with the donor nerve of the flap

Interventions

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innervated sensate flap

sensory reconstruction via digital nerve repair with the donor nerve of the flap

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* thumbtip degloving injury with a projecting tip of exposed bone or/and pulp defect; the defect ≥2 cm in length associated with the transected digital nerves in both sides; necessity to preserve thumb length; patient at or younger than 55 years of age

Exclusion Criteria

* injury to the dorsum of the proximal or/and middle phalanx of the index finger; injury to the course of the FDMA; thumb nail bed defect; radial or ulnar portion of thumbtip or pulp defect

Minimum Eligible Age

15 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes