Sensory Reconstruction of the Digits

NCT02695485 | Completed DMC

• 1 other identifier: TSZhao9012
• Study Type: interventional
• Target: 151
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Soft Tissue Defect of Digit

Keywords

dorsal digital island flap; sensory reconstruction

Outcome Measures

Primary Outcomes (2)

• Static 2PD test

  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.

  18 months to 24 months after surgery

• Pain sensation using the visual analogue scale

  Using the visual analogue scale (VAS) that consists of a 10 cm line, patients are asked to report pain sensations of the recipient site.

  18 months to 24 months after surgery

Study Arms (1)

sensate flap

OTHER

the donor nerve harvested with the flap

Procedure: innervated sensate flap

Interventions

innervated sensate flap PROCEDURE

sensory reconstruction via digital nerve repair with the donor nerve of the flap

sensate flap

Eligibility Criteria

• Age: 15 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Second Hospital of Tangshan: lead
• Chinese PLA General Hospital: collaborator

Related Publications (1)

• Chen C, Tang P, Zhang X. The dorsal homodigital island flap based on the dorsal branch of the digital artery: a review of 166 cases. Plast Reconstr Surg. 2014 Apr;133(4):519e-529e. doi: 10.1097/PRS.0000000000000016.

  PMID: 24675204 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2016
• First Posted: March 1, 2016
• Study Start: February 1, 2006
• Primary Completion: March 1, 2013
• Study Completion: October 1, 2015
• Last Updated: March 1, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will share