Bilaterally Innervated Sensory Dorsal Digital Flaps for Sensory Reconstruction of the Fingers

Not Applicable

Completed

• Conditions: Soft Tissue Injuries
• Interventions: Procedure: Flap including bilateral nerve branches

• Registration Number: NCT02167646
• Lead Sponsor: The Second Hospital of Tangshan

Brief Summary

Sensory coverage in the finger continues to be a challenging problem. This study reports sensory reconstruction of the fingers with the bilaterally innervated dorsal digital flaps and compares the results between the dual- and single-innervated flaps.The main evaluated outcomes are static 2-point discrimination and Semmes-Weinstein monofilament scores of the flap, fingertip pain and joint motion.

Detailed Description

Pain was given subjectively by the patient using the visual analogue scale (VAS). The VAS consists of a 10 cm line that was grouped into mild (0-3 cm), moderate (4-6 cm) and severe (7-10 cm). Tinel's sign was rated as the following: 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.

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2011-04
• Status Verified: 2012-02
• Study Completion: 2013-08
• Study First Submitted: 2014-06-17
• Study First Submitted QC: 2014-06-18
• Study First Posted: 2014-06-19
• Last Update Submitted: 2018-10-25
• Last Update Posted: 2018-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

Inclusion Criteria

• a soft-tissue defect in the areas where sensory return was considered important ●a defect with exposed bone or tendon in one finger
• the defect associated with the transected digital nerves in both sides
• a defect greater than 1.5 cm
• a patient aged 15 to 60 years

Exclusion Criteria

• injuries to the dorsum of the finger or to the course of the vascular pedicle that precluded its use as the donor
• injuries to the dorsal branches of the digital nerves that precluded its use as donor nerves attached with the flap
• a defect less than or equal to 1.5 cm
• patient age < 15 years or > 60 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bilaterally innervated flap	Flap including bilateral nerve branches	Two nerve branches attached with the flap for sensory reconstruction.

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

Trial Locations

Locations (1)

The Second Hospital of Tangshan; 🇨🇳 Tangshan, Hebei, China