A Comparison of the Littler Flap With the Bipedicled Nerve Flap

Not Applicable

Completed

• Conditions: Nerve Injury; Soft Tissue Defect of Digit
• Interventions: Procedure: nerve flap

• Registration Number: NCT03701685
• Lead Sponsor: The Second Hospital of Tangshan

Brief Summary

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.

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 Timeline

• Study Start: 2008-07
• Primary Completion: 2016-02
• Study Completion: 2016-05
• Status Verified: 2018-08
• Study First Submitted: 2018-10-08
• Study First Submitted QC: 2018-10-08
• Study First Posted: 2018-10-10
• Last Update Submitted: 2018-10-12
• Last Update Posted: 2018-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
nerve grafting	nerve flap	The stumps of digital nerve are connected with nerve graft

Primary Outcome Measures

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