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Completed

NCT Number: NCT01826539

A Comparison of Dorsal Branch of the Digital Nerve Versus Dorsal Digital Nerve for Finger Pulp Reconstruction

As the donor nerve attached with the flap, the dorsal branch of the digital nerve and the dorsal digital nerve is commonly used for finger pulp reconstruction.This study compares two donor nerves: the dorsal branch of the digital nerve and the dorsal digital nerve.

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Key information

Conditions

Soft Tissue Defect of the Finger

Age range

15 year–55 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

The investigators compares two donor nerves attached with the flap for sensory reconstruction of finger pulp: the dorsal branch of the digital nerve and the dorsal digital nerve. The main outcomes were static 2-point discrimination and Semmes-Weinstein monofilament scores of the flap, and pain and cold intorlence of the reconstructed finger.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • The pulp or fingertip defect in only one finger
  • A defect greater than or equal to 1.5 cm in length
  • Necessity to preserve finger length
  • A patient between 18 and 60 years of age

Exclusion criteria

  • Injuries to the dorsum of the middle phalanx
  • Injuries to the course of the vascular pedicle or donor nerve
  • A defect less than 1.5 cm in length
  • Multiple finger pulp defect
  • Extremely contaminated wounds

Treatment and study plan

flap includes a donor nerve

Procedure

the donor nerve is attached with the flap for sensory reconstruction of the finger

Primary outcomes

  1. static 2-point discrimination (2PD) test

    Time frame: 18 months to 26 months

    The test points are at the center of the radial or ulnar portion of the pulp. Each area is tested 3 times with a Discriminator. We stop at 4mm as a limit of 2PD and consider this normal.

Secondary outcomes

  1. Cold intolerance

    Time frame: 18 months to 26 months

    Cold intolerance in the reconstructed finger is assessed using the self-administered Cold Intolerance Severity Score questionnaire [10]. The maximum score is 100 and was group into 4 ranges (0-25, 26-50, 51-75, and 76-100), corresponding to mild, moderate, severe, and extreme severity, respectively.

Other outcomes

  1. Pain

    Time frame: 18 months to 26 months

    Using the visual analogue scale (VAS), patients are asked to report pain sensations of the reconstructed pulps and donor sites. The VAS consists of a 10 cm line that is grouped into mild (0-3 cm), moderate (4-6 cm) and severe (7-10 cm).

Sponsors and collaborators

Lead sponsor

The Second Hospital of Tangshan

Other

Collaborators

  • Chinese PLA General Hospital

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 8, 2013
Registry last updated
Apr 8, 2013

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.