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

T

The Second Hospital of Tangshan

Status

Completed

Conditions

Soft Tissue Injuries

Treatments

Procedure: Flap including bilateral nerve branches

Study type

Interventional

Funder types

Other

Identifiers

NCT02167646
HBTS14-01502 (Other Identifier)
TSChen10512

Details and patient eligibility

About

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.

Full description

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.

Enrollment

73 patients

Sex

All

Ages

15 to 60 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

73 participants in 1 patient group

Bilaterally innervated flap
Other group
Description:
Two nerve branches attached with the flap for sensory reconstruction.
Treatment:
Procedure: Flap including bilateral nerve branches

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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