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Completed

NCT Number: NCT03717220

Reconstructive of Multiple-digit Soft-tissue Defects Using Regional Dorsal Digital Flaps

Reconstruction of soft-tissue defects in multiple digits poses a significant challenge. This article reports simultaneous reconstruction of multiple small-to-moderate soft-tissue defects using regional dorsal digital island flaps and evaluated the efficacy of their application in such complex situation. A retrospective study will be conducted with 26 patients who had multiple-digit soft-tissue defects treated with regional dorsal digital island flaps. At the final follow-up, we will evaluate the efficacy of their application in such complex situation.

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Key information

Conditions

Finger Injuries Hand Injuries Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

For the recipient where sensory restoration is important, sensation of the flaps is assessed using static two-point discrimination (2PD) and Semmes-Weinstein monofilament (SWM) testing at final follow-up. The cold intolerance of the injured finger is measured using the self-administered Cold Intolerance Severity Score questionnaire that was rated into mild, moderate, severe, and extreme (0-25, 26-50, 51-75 and 76-100). The pain of the injured finger is given subjectively by the patient using a grading system that included grade 1, none; grade 2, mild, no interference with daily activities; grade 3, moderate, patient works but has some limitation in use of the hand because of pain; and grade 4, severe, cannot work or use hand. To sum up, patients report their satisfaction with functional recovery of the injured finger according to the Michigan Hand Outcomes Questionnaire that was based on a 5-point response scale.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • the separate soft tissue defects with exposed bone or tendon in different digits
  • the soft-tissue defect≥1.5 cm and ≤3.5 cm in length
  • necessity to preserve digit length
  • local tissue near the defect can be used as the donor
  • a patient between 15 and 60 years of age

Exclusion criteria

  • concomitant injuries to the dorsum of the injured finger
  • a defect < 1.5 cm and>3.5 cm in length
  • a finger degloving injury
  • the defect of the thumb

Treatment and study plan

flap transferring

Procedure

we use regional dorsal digital flaps for simultaneous reconstruction of multiple-digit soft-tissue defects

Primary outcomes

  1. Static 2PD test

    Time frame: 18 months to 24 months

    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
2016
Study completion
2016
First posted
Oct 24, 2018
Registry last updated
Oct 24, 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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