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

NCT01778296 — Not applicable, Completed, 12 participants, The Second Hospital of Tangshan

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RegistryNCT01778296
StatusCompleted
PhaseNot applicable
Study typeInterventional; na, single group, masking: none, treatment
Enrollment12 (Actual)
SponsorThe Second Hospital of Tangshan (Other); collaborators: Chinese PLA General Hospital
ConditionsSensory Reconstruction of the Volar Aspect of the Finger, The Heterodigital Neurocutaneous Island Flap
Interventionsthe neurocutaneous island flap (Device)
Datesstart 2008-01-01, primary completion 2012-03-01, completion 2012-10-01, first posted 2013-01-29, last updated 2024-02-14
Locations1 site in China

Related Papers Related Patents Related Grants Related Experts
All trials for Sensory Reconstruction of the Volar Aspect of the Finger All trials for The Heterodigital Neurocutaneous Island Flap All trials of the neurocutaneous island flap

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Surgical flapExperimentalDevice: the neurocutaneous island flapThe neurocutaneous island flap is based on the dorsal branch of the digital nerve
  • the neurocutaneous island flap (Device), also known as dorsal digital island flap: 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.

+Outcome measures

Primary outcomes

  • Discriminatory Sensation of the Flap [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]: 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).

+Eligibility

Sex: All, ages: 15 Years to 60 Years, accepts healthy volunteers

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.

+Posted results

Participant flow

MilestoneSurgical Flap
Started12
Completed12
Not completed0

Outcome results

  • Discriminatory Sensation of the Flap (Primary), Mean, mm: Surgical Flap 8.3 +/- 1.6
  • Cold Intolerance (Secondary)

Adverse events

Time frame: One year

ArmDeathsSerious adverse eventsOther adverse events
Surgical Flap00/12 (0.0%)0/12 (0.0%)

Limitations and caveats: The samples of our study are small, and the results may change as our experience grows.

+Locations (1)

FacilityCityCountryStatus
The Second Hospital of TangshanTangshan, HebeiChina

+Publications

  • Results publication: Chen C, Zhang X, Shao X, Gao S, Wang B, Liu D. Treatment of a combination of volar soft tissue and proper digital nerve defects using the dorsal digital nerve island flap. J Hand Surg Am. 2010 Oct;35(10):1655-1662.e3. doi: 10.1016/j.jhsa.2010.07.011. PMID 20888502
  • Results publication: Wang B, Zhao Y, Lu A, Chen C. Ulnar nerve deep branch compression by a ganglion: a review of nine cases. Injury. 2014 Jul;45(7):1126-30. doi: 10.1016/j.injury.2014.03.017. Epub 2014 Apr 3. PMID 24774037
  • Results publication: Chen C, Tang P, Zhang L. Reconstruction of a soft tissue defect in the finger using the heterodigital neurocutaneous island flap. Injury. 2013 Nov;44(11):1607-14. doi: 10.1016/j.injury.2013.06.025. Epub 2013 Jul 18. PMID 23871427