A Comparison of the Littler Flap With the Bipedicled Nerve Flap

A Comparison of the Littler Flap With the Bipedicled Nerve Flap for Sensory Reconstruction of Digits

A retrospective study is conducted with 59 patients who has a combination of soft tissue and digital nerve defects following trauma treated using the Littler flap or bipedicle nerve flap.Patients are divided into two groups. The group reconstructed with the Litter flap includes 26 patients and the group reconstructed with the bipedicle nerve flap includes 33 patients.Discriminatory sensation, pain and cold intolerance of the reconstructed finger, and patient satisfaction were evaluated.

Study Overview

• Status: Completed
• Conditions: Nerve Injury; Soft Tissue Defect of Digit
• Intervention / Treatment: Procedure: nerve flap

Detailed Description

At final follow-up, we measured the sensation of the pulp of the reconstructed finger and the flap using the static two-point discrimination (2PD) test and Semmes-Weinstein monofilament (SWM) examination. The test points were at the centers of the radial and ulnar portions of the finger pulp and the flap. Cold intolerance of the injured and donor fingers was assessed using the self-administered Cold Intolerance Severity Score questionnaire. The maximum score was 100; scores were grouped as mild (0 to 25), moderate (26 to 50), severe (51 to 75), and extremely severe (76 to 100). Pain was given subjectively by the patient using a grading system that included grade 1, none; grade 2, mild, no interference with daily activities; grade 3, moderate, patient works but has some limitation in use of the hand because of pain; and grade 4, severe, cannot work or use hand. The Tinel sign on the donor and recipient sites was graded as follows: grade 1, none; grade 2, mild, slight tingle; grade 3, moderate, very uncomfortable; and grade 4, severe, patient unable to use hand because of any stimulation of the neuroma. Finally, patients reported their satisfaction with functional recovery of the injured finger according to the Michigan Hand Outcomes Questionnaire that was based on a 5-point response scale. All tests were performed by an independent senior hand surgeon.

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 55 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• the defect in a region where sensory return is considered important
• soft tissue defect with exposed bone or tendon in only one digit
• associated single or double digital nerve defects with 1 to 4 cm in length7
• a soft tissue defect greater than 1.5 cm and less than 4 cm in length
• necessity to preserve digit length
• a patient between 15 and 60 years of age.

Exclusion Criteria:

• injury to the course of donor arterial pedicle or donor nerve
• nerve defect less than 1 cm or larger than 4 cm
• a soft tissue defect≤1.5 cm or ≥4 cm in length
• multiple-digit soft tissue defects
• extremely contaminated wounds
• the defect in a region the flap is unable to reach, such as thumb fingertip

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: nerve grafting; The stumps of digital nerve are connected with nerve graft	Procedure: nerve flap; sensory reconstruction via a nerve graft included in the flap

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Static 2PD test	We use a Disk-Criminator to test two nearby points when touching the flap. It is often	18 months to 24 months after surgery

Collaborators and Investigators

• Sponsor: The Second Hospital of Tangshan
• Collaborators: Chinese PLA General Hospital

Publications and helpful links

General Publications

• Chen C, Tang P, Zhang L. Use of a bipedicled nerve flap taken from the dorsum of the digit for reconstruction of neurocutaneous defect in the adjacent finger. J Plast Reconstr Aesthet Surg. 2013 Oct;66(10):1322-9. doi: 10.1016/j.bjps.2013.06.001. Epub 2013 Jul 2.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2008
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: October 8, 2018
• First Submitted That Met QC Criteria: October 8, 2018
• First Posted (Actual): October 10, 2018

Study Record Updates

• Last Update Posted (Actual): October 15, 2018
• Last Update Submitted That Met QC Criteria: October 12, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: nerve repair; sensory reconstruction; nerve flap
• Other Study ID Numbers: TSChen13307

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No