Sensory Reconstruction of the Digits

T

The Second Hospital of Tangshan

Status

Completed

Conditions

Soft Tissue Defect of Digit

Treatments

Procedure: innervated sensate flap

Study type

Interventional

Funder types

Other

Identifiers

NCT02695485
TSZhao9012

Details and patient eligibility

About

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.

Full description

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.

Enrollment

151 patients

Sex

All

Ages

15 to 60 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

151 participants in 1 patient group

sensate flap
Other group
Description:
the donor nerve harvested with the flap
Treatment:
Procedure: innervated sensate flap

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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