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Clinical Trials/NCT01778296
NCT01778296
Completed
Not Applicable

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

The Second Hospital of Tangshan1 site in 1 country12 target enrollmentJanuary 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sensory Reconstruction of the Volar Aspect of the Finger
Sponsor
The Second Hospital of Tangshan
Enrollment
12
Locations
1
Primary Endpoint
Discriminatory Sensation of the Flap
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
January 2008
End Date
October 2012
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

  • Cold Intolerance(18 months to 24 months)

Study Sites (1)

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