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Completed

NCT Number: NCT01767727

Repair of Multiple Finger Defects Using the Dorsal Homodigital Island Flaps

Multiple finger defects are common in hand trauma and result in functional disability. These injuries are often complex and severe, and thus reconstructive alternatives are limited. In this study, we use the dorsal homodigital island flaps, based on the dorsal branch of the digital artery, for reconstruction of multiple finger defects. At the final follow-up, we would evaluate the efficacy of this technique.

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Key information

Conditions

Finger Injuries Hand Injuries 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

At final follow-up, sensation of the flap and the donor site would be assessed using static two-point discrimination and Semmes-Weinstein monofilament testing. The range of motion of the proximal interphalangeal joint and the distal interphalangeal joint of the injured finger is measured by a goniometer. The cold intolerance of the injured finger is measured using the self-administered Cold Intolerance Severity Score questionnaire that is rated into mild, moderate, severe, and extreme. The pain of the injured finger and the donor site is given subjectively by the patient using the visual analogue scale, which ranges from 0 to 10 cm and groupes into mild (0-3 cm), moderate (4-6 cm) and severe (7-10 cm).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • a patient who had separate soft tissue defects in different fingers in same hand;
  • the defect ≥ 1.5 cm and ≤ 3.5 cm in length;
  • local tissue near the defect is uninjured; and
  • a patient between 15 and 60 years of age.

Exclusion criteria

  • concomitant injuries to local tissue around the defect that precluded its use as donor site;
  • a defect < 1.5 cm and ≥ 3.5 cm in length;
  • a finger degloving injury;
  • the defect of the thumb.

Treatment and study plan

Soft tissue coverage

Procedure

The dorsal homodigital island flaps are used for soft tissue coverage of multiple finger defects

Primary outcomes

  1. static two-point discrimination

    Time frame: postoperative 18-24 months

    The test points are at the center of the flap.Each area is tested 3 times with a Discriminator. We stopp at 4 mm as a limit of two-point discrimination and consider this normal.

Secondary outcomes

  1. Cold intolerance of the injured finger

    Time frame: Postoperative 18-24 months

    The cold intolerance of the injured finger was measured using the self-administered Cold Intolerance Severity Score questionnaire that was rated into mild, moderate, severe, and extreme.

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
2012
First posted
Jan 14, 2013
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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