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

This study has been completed.
Sponsor:
Collaborator:
Chinese PLA General Hospital
Information provided by (Responsible Party):
The Second Hospital of Tangshan
ClinicalTrials.gov Identifier:
NCT01778296
First received: January 25, 2013
Last updated: October 23, 2013
Last verified: May 2012
  Purpose

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.


Condition Intervention
Sensory Reconstruction of the Volar Aspect of the Finger
The Heterodigital Neurocutaneous Island Flap
Device: the neurocutaneous island flap

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Further study details as provided by The Second Hospital of Tangshan:

Primary Outcome Measures:
  • Discriminatory Sensation of the Flap [ Time Frame: 18 months to 24 months ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Cold Intolerance [ Time Frame: 18 months to 24 months ] [ Designated as safety issue: No ]
    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).


Enrollment: 12
Study Start Date: January 2008
Study Completion Date: October 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Surgical flap
The neurocutaneous island flap is based on the dorsal branch of the digital nerve
Device: the neurocutaneous 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.
Other Name: dorsal digital island flap

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.

  Eligibility

Ages Eligible for Study:   15 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01778296

Locations
China, Hebei
The Second Hospital of Tangshan
Tangshan, Hebei, China, 063000
Sponsors and Collaborators
The Second Hospital of Tangshan
Chinese PLA General Hospital
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: The Second Hospital of Tangshan
ClinicalTrials.gov Identifier: NCT01778296     History of Changes
Other Study ID Numbers: HBTS1301283, CHS1301-00146
Study First Received: January 25, 2013
Results First Received: June 3, 2013
Last Updated: October 23, 2013
Health Authority: China: Ethics Committee
United States: Food and Drug Administration

Keywords provided by The Second Hospital of Tangshan:
Dorsal branch of the digital nerve;
dorsal digital artery;
dorsal digital island flap;
neurocutaneous island flap.

ClinicalTrials.gov processed this record on July 22, 2014