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

January 19, 2024 updated by: The Second Hospital of Tangshan
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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Hebei
      • Tangshan, Hebei, China, 063000
        • The Second Hospital of Tangshan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Surgical flap
The neurocutaneous island flap is based on the dorsal branch of the digital nerve
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
18 months to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
18 months to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

January 25, 2013

First Submitted That Met QC Criteria

January 28, 2013

First Posted (Estimated)

January 29, 2013

Study Record Updates

Last Update Posted (Actual)

February 14, 2024

Last Update Submitted That Met QC Criteria

January 19, 2024

Last Verified

May 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • HBTS1301283
  • CHS1301-00146 (Other Identifier: Hebei Clinical Trail Committee)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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