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

NCT02167646 | Completed DMC

• 2 other identifiers: TSChen10512HBTS14-01502
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Soft Tissue Injuries

Keywords

Soft tissue defect; dorsal branch of the digital nerve; dorsal branch of the digital artery; dorsal digital flap

Outcome Measures

Primary Outcomes (1)

• Static 2PD test

  We use a Disk-Criminator to test two nearby points when touching the flap

  18 months to 24 months after surgery

Study Arms (1)

Bilaterally innervated flap

OTHER

Two nerve branches attached with the flap for sensory reconstruction.

Procedure: Flap including bilateral nerve branches

Interventions

Flap including bilateral nerve branches PROCEDURE

Two nerve branches are attached with the flap for sensory coverage

Bilaterally innervated 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:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

The Second Hospital of Tangshan

Tangshan, Hebei, 063000, China

Location

Related Publications (2)

• 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

• Chen C, Tang P, Zhao G. Bilaterally innervated dorsal digital flap for sensory reconstruction of digits. Injury. 2014 Dec;45(12):2018-24. doi: 10.1016/j.injury.2014.09.012. Epub 2014 Sep 22.

  PMID: 25304161 DERIVED

MeSH Terms

Conditions

Soft Tissue Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

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: June 17, 2014
• First Posted: June 19, 2014
• Study Start: January 1, 2008
• Primary Completion: April 1, 2011
• Study Completion: August 1, 2013
• Last Updated: October 29, 2018

Record last verified: 2012-02

Locations

CN (1)