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

• ClinicalTrials.gov Identifier: NCT01778296
• Recruitment Status: Completed
• First Posted: January 29, 2013
• Results First Posted: November 18, 2013
• Last Update Posted: November 18, 2013
• Sponsor: The Second Hospital of Tangshan
• Collaborator: Chinese PLA General Hospital
• Information provided by (Responsible Party): The Second Hospital of Tangshan

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Sensory Reconstruction of the Volar Aspect of the Finger; The Heterodigital Neurocutaneous Island Flap	Device: the neurocutaneous island flap	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Study Start Date: January 2008
• Actual Primary Completion Date: March 2012
• Actual Study Completion Date: October 2012

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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).

Eligibility Criteria

• Ages Eligible for Study: 15 Years to 60 Years (Child, Adult)
• Sexes Eligible for Study: All
• 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

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 of Results:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• Responsible Party: The Second Hospital of Tangshan
• ClinicalTrials.gov Identifier: NCT01778296
• Other Study ID Numbers: HBTS1301283; CHS1301-00146 ( Other Identifier: Hebei Clinical Trail Committee )
• First Posted: January 29, 2013
• Results First Posted: November 18, 2013
• Last Update Posted: November 18, 2013
• Last Verified: May 2012

Keywords provided by The Second Hospital of Tangshan:

Dorsal branch of the digital nerve; dorsal digital artery; dorsal digital island flap; neurocutaneous island flap.