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Completed

NCT Number: NCT02167646

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

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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Key information

Conditions

Soft Tissue Injuries Wounds and Injuries

Age range

15 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second Hospital of Tangshan

Tangshan, Hebei, 063000, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Flap including bilateral nerve branches

Procedure

Two nerve branches are attached with the flap for sensory coverage

Primary outcomes

  1. Static 2PD test

    Time frame: 18 months to 24 months after surgery

    We use a Disk-Criminator to test two nearby points when touching the flap

Sponsors and collaborators

Lead sponsor

The Second Hospital of Tangshan

Other

Collaborators

  • Chinese PLA General Hospital

Registry information

Important dates

Study start
2008
Primary completion
2011
Study completion
2013
First posted
Jun 19, 2014
Registry last updated
Oct 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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