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

NCT01778296 | Completed Results DMC

• 2 other identifiers: HBTS1301283CHS1301-00146
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Sensory Reconstruction of the Volar Aspect of the Finger; The Heterodigital Neurocutaneous Island Flap

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Discriminatory Sensation of the Flap

  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 Outcomes (1)

• Cold Intolerance

  18 months to 24 months

Study Arms (1)

Surgical flap

EXPERIMENTAL

The neurocutaneous island flap is based on the dorsal branch of the digital nerve

Device: the neurocutaneous island flap

Interventions

the neurocutaneous island flap DEVICE

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.

Also known as: dorsal digital island flap

Surgical flap

Eligibility Criteria

• Age: 15 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Second Hospital of Tangshan: lead
• Chinese PLA General Hospital: collaborator

Study Sites (1)

The Second Hospital of Tangshan

Tangshan, Hebei, 063000, China

Location

Related Publications (3)

• 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 RESULT

• 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 DERIVED

• 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 DERIVED

Limitations and Caveats

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

Results Point of Contact

• Title: Dr. Chao Chen
• Organization: The Second Hospital of Tangshan

ts_chenchao@163.com

86-13700350471

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2013
• First Posted: January 29, 2013
• Study Start: January 1, 2008
• Primary Completion: March 1, 2012
• Study Completion: October 1, 2012
• Last Updated: February 14, 2024
• Results First Posted: November 18, 2013

Record last verified: 2012-05

Locations

CN (1)