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Completed

NCT Number: NCT01871103

The Dorsal Homodigital Island Flap Based on the Dorsal Branch of the Digital Artery: A Review of 171 Cases

Soft tissue reconstruction in the finger continues to evolve. The dorsum of the finger is a reliable flap donor site in reconstructive hand surgery because of its similar quality to the original. The dorsal homodigital island flap can be used as a reliable alternative for reconstructing small to moderate defects of the fingers. In this retrospective study, the investigators would evaluate the efficacy of the technique for tissue reconstruction in different regions of the finger, with an emphasis on sensibility, pain and donor site morbidity.

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Key information

Conditions

Soft Tissue Defect Multiple Digital Defects Sensory Reconstruction of Digits

Age range

18 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, sensory restoration of the flap is measured using the static 2-point discrimination test and Semmes-Weinstein monofilament test. We evaluate pain sensations of the reconstructed fingers and donor sites with a visual analog scale. The system consist of a 10 cm line that is grouped into mild (0-3 cm), moderate (4-6 cm) and severe (7-10 cm). Active motion of the joints is measured using a goniometer. The motion arcs of the reconstructed fingers are compared with the opposite side.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • the soft tissue defect in one finger or in multiple fingers
  • a defect > 1.5 cm and < 3 cm in length
  • necessity to preserve finger length
  • a patient between 15 and 60 years of age

Exclusion criteria

  • injuries to the dorsum of the finger or to the course of the vascular pedicle that precluded its use as the donor
  • a defect≤1.5 cm or ≥3 cm in length
  • a soft tissue defect of the thumb

Treatment and study plan

The dorsal homodigital island flap

Procedure

The dorsal homodigital island flap is used for tissue reconstruction in different regions of the finger.

Primary outcomes

  1. Static 2-point discrimination test

    Time frame: 18 months to 24 months

    The test point is at the center of the flap. Each area was tested 3 times with a Discriminator (Ali Med, Dedham, MA). We stop at 4mm as a limit of 2PD and considered this normal.

Secondary outcomes

  1. Cold intolerance

    Time frame: 18 months to 24 months

    We access the cold intolerance of the injured and donor fingers using the self-administered Cold Intolerance Severity Score questionnaire10 that is rated into mild, moderate, severe, and extreme (0-25, 26-50, 51-75 and 76-100).

Sponsors and collaborators

Lead sponsor

The Second Hospital of Tangshan

Other

Collaborators

  • Chinese PLA General Hospital

Registry information

Important dates

Study start
2006
Primary completion
2009
Study completion
2013
First posted
Jun 6, 2013
Registry last updated
Jun 6, 2013

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

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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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