Sensory Reconstruction of the Digits

Not Applicable

Completed

• Conditions: Soft Tissue Defect of Digit
• Interventions: Procedure: innervated sensate flap

• Registration Number: NCT02695485
• Lead Sponsor: The Second Hospital of Tangshan

Brief Summary

A retrospective study is conducted with 151 patients who has a soft tissue defect of digit treated with the sensate flaps from February 2005 to March 2014. Based on the different regions of soft tissue defects, the patients in the study are divided into four groups: (1) thumb group treated with the bilaterally innervated and traditional kite flaps; (2) distal finger group treated with the single- and dual-innervated dorsal digital flaps; (3) proximal finger group treated with heterodigital neurocutaneous island flap; and (4) awkward region group treated with Litter flap. The main outcomes are static 2-point discrimination and Semmes-Weinstein monofilament scores of the flap, and pain and patient satisfaction.

Detailed Description

At final follow-up, sensory restoration of the flap is measured using the static 2PD test and Semmes-Weinstein monofilament test. Using the visual analogue scale (VAS) that consists of a 10 cm line, patients are asked to report pain sensations of the recipient site. Patients report their satisfaction with functional recovery of the injured finger according to the Michigan Hand Outcomes Questionnaire that is based on a 5-point response scale.

Study Timeline

• Study Start: 2006-02
• Primary Completion: 2013-03
• Study Completion: 2015-10
• Status Verified: 2016-02
• Study First Submitted: 2016-02-19
• Study First Submitted QC: 2016-02-29
• Last Update Submitted: 2016-02-29
• Study First Posted: 2016-03-01
• Last Update Posted: 2016-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 151

Inclusion Criteria

• thumbtip degloving injury with a projecting tip of exposed bone or/and pulp defect; the defect ≥2 cm in length associated with the transected digital nerves in both sides; necessity to preserve thumb length; patient at or younger than 55 years of age

Exclusion Criteria

• injury to the dorsum of the proximal or/and middle phalanx of the index finger; injury to the course of the FDMA; thumb nail bed defect; radial or ulnar portion of thumbtip or pulp defect

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
sensate flap	innervated sensate flap	the donor nerve harvested with the flap

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 tested with two sharp points during a neurological examination and is assumed to reflect how finely innervated an area of flap is.
Pain sensation using the visual analogue scale	18 months to 24 months after surgery	Using the visual analogue scale (VAS) that consists of a 10 cm line, patients are asked to report pain sensations of the recipient site.