Skip to main content
OpenTrials
Completed

NCT Number: NCT01778296

Repair of Soft Tissue Defect of the Finger Using the Heterodigital Neurocutaneous Island Flap

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 digital island flap can be used for repairing the defect of adjacent finger, but the limited length of the pedicle precludes its use for a more distal defect. The heterodigital neurocutaneous island flap of the dorsal branch of the digital nerve can be used as an alternative to resolve this problem.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sensory Reconstruction of the Volar Aspect of the Finger The Heterodigital Neurocutaneous Island Flap

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, we measured the sensibility of the flaps using the Semmes-Weinstein monofilament test and the static 2-point discrimination test. The test points were at the center of the radial or ulnar portion of the pulp. The donor site, i.e. radial- or ulnar-dorsal aspect of the middle phalanx of the donor digit, was also evaluated. Each area was tested 3 times with a Discriminator (Ali Med, Dedham, MA). We stopped at 4mm as a limit of 2PD and considered this normal.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • the soft tissue defects involving the middle phalanx, the proximal interphalangeal joint, or both;
  • a defect greater than or equal to 2 cm in length;
  • a patient between 15 and 60 years of age.

Exclusion criteria

  • concomitant injuries to the dorsal skin of the middle phalanx of adjacent finger that precluded its use as donor site;
  • injuries to the course of donor nerve branch;
  • a defect less than 1.5 cm in length;
  • a fingertip or pulp defect;
  • a soft tissue defect of the thumb.

Treatment and study plan

the neurocutaneous island flap

Device

The neurocutaneous island flap of the dorsal branch of the digital nerve can be used for repair the defects of the proximal and middle phalanxes of adjacent fingers.

Other names: dorsal digital island flap

Primary outcomes

  1. Discriminatory Sensation of the Flap

    Time frame: 18 months to 24 months

    Discriminatory sensation of the flap is evaluated with the Static 2-point Discrimination Test. The test determines the minimal distance at which a subject can sense the presence of two needles. The modified American Society for Surgery of the Hand guidelines were used to stratify Discriminator measurements (excellent <6 mm; good 6-10 mm; fair 11-15 mm; poor >15 mm. The test point is at the center of the flap. Each area was tested 3 times with a Discriminator (Ali Med, Dedham, MA). Two out of 3 correct answers were considered proof of perception before proceeding to another lower value. We stop at 4mm as a limit of 2PD and considered this normal. These assessments take place at a single time point at the final follow-up.

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
2008
Primary completion
2012
Study completion
2012
First posted
Jan 29, 2013
Registry last updated
Feb 14, 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.