A Comparison of the Littler Flap With the Bipedicled Nerve Flap

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.

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Key information

Conditions

Soft Tissue Defect of Digit Nerve Injury

Age range

15 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nerve flap

Procedure

sensory reconstruction via a nerve graft included in the flap

Primary outcomes

Static 2PD test

Time frame: 18 months to 24 months after surgery

We use a Disk-Criminator to test two nearby points when touching the flap. It is often

Sponsors and collaborators

Lead sponsor

The Second Hospital of Tangshan

Other

Collaborators

Chinese PLA General Hospital

Registry information

Official study title

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

Important dates

Study start: 2008
Primary completion: 2016
Study completion: 2016
First posted: Oct 10, 2018
Registry last updated: Oct 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed