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Completed

NCT Number: NCT01533337

Free Dorsal Digital Flap for Reconstruction of Volar Soft Tissue Defect of Digits

The aim of the current report is to investigate the feasibility of transferring the free dorsal digital flap, including both dorsal branches of the proper digital nerves (PDNs), to reconstruct the volar soft tissue defect of digits. Sensory restoration of the reconstructed digit was evaluated via static two-point discrimination (2PD). The range of motion (ROM) of the donor middle and ring fingers was measured.

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Key information

Age range

15 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Sensory restoration of the reconstructed digit was evaluated via static two-point discrimination (2PD). The range of motion (ROM) of the donor middle and ring fingers was measured. The data were compared with those of the contralateral, uninjured hand.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • soft tissue defects in the fingertip, pulp, or volar surface of the digits;
  • a defect > 2 cm in length;
  • unavailability of the homodigital and heterodigital island flaps because of concomitant injuries to donor fingers; and
  • the patient refuses to use tissues from the toe.

Exclusion criteria

  • soft tissue defects in the dorsum of the digits;
  • a defect < 2 cm in length;
  • homodigital and heterodigital island flaps are available.

Treatment and study plan

Free dorsal digital flap

Procedure

The dorsal digital flap, including both dorsal branches of the proper digital nerves, was designed on the dorsum of the donor finger between the distal third of the proximal phalanx and the distal interphalangeal joint.

Primary outcomes

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

    Time frame: 25 months

    The test points were at the centers of the radial and ulnar portions of the digital pulp and the donor sites separately. Each area was tested 3 times with a Dellon-Mackinnon discriminator. Two out of 3 correct answers were considered proof of perception before proceeding to another lower value.

Sponsors and collaborators

Lead sponsor

The Second Hospital of Tangshan

Other

Collaborators

  • Chinese PLA General Hospital

Registry information

Important dates

Study start
2007
Primary completion
2009
Study completion
2011
First posted
Feb 15, 2012
Registry last updated
Jan 22, 2024

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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