Reconstruction of a Neurocutaneous Defect of the Proximal Phalanx With a Heterodigital Arterialized Nerve Pedicle Flap

NCT01837407 | Completed DMC

• 2 other identifiers: TSChen8871HBTS13-04102
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

Complex digital injuries involving soft tissue loss and digital nerve defect pose challenging problems for hand surgeons. This study uses the heterodigital arterialized nerve pedicle flap including the dorsal branch of the digital nerve for reconstructing a digital neurocutaneous defect of the proximal phalanx.

Conditions

Complex Digital Injuries

Keywords

Soft tissue loss; nerve defect; dorsal branch of the proper digital nerve; heterodigital arterialized nerve pedicle flap; Composite Flap; nerve flap; nerve transfer

Outcome Measures

Primary Outcomes (1)

• Static 2-point discrimination test

  The test points are at the center of the radial or ulnar portion of the pulp. Each area is tested 3 times with a Discriminator. The investigators stop at 4mm as a limit of 2PD and consider this normal.

  18 months to 24 months

Secondary Outcomes (1)

• Cold Intolerance Severity Score (CISS) questionnaire.

  18 months to 24 months

Other Outcomes (1)

• Visual analog scale

  18 months to 24 months

Study Arms (1)

Surgical flap

OTHER

The flap includes the nerve for repair of the soft tissue and nerve defects

Procedure: Composite Flap

Interventions

Composite Flap PROCEDURE

nerve transfer with the dorsal branch of the digital nerve

Surgical flap

Eligibility Criteria

• Age: 15 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• a neurocutaneous defect at the proximal phalanx
• a soft tissue defect on the volar, dorsal, and contiguous lateral aspects of adjacent fingers .associated digital nerve defect.

You may not qualify if:

• an injury involving the course of the arterial or venous pedicle; an injury involving donor site or donor nerve
• a soft tissue defect on the noncontiguous lateral aspects of adjacent fingers
• a nerve injury that is able to be repaired by primary neurorrhaphy

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, Zhang X, Shao X, Gao S, Wang B, Liu D. Treatment of a combination of volar soft tissue and proper digital nerve defects using the dorsal digital nerve island flap. J Hand Surg Am. 2010 Oct;35(10):1655-1662.e3. doi: 10.1016/j.jhsa.2010.07.011.

  PMID: 20888502 RESULT

• Chen C, Tang P, Zhang X. Reconstruction of a neurocutaneous defect of the proximal phalanx with a heterodigital arterialised nerve pedicle flap. Injury. 2014 Apr;45(4):799-804. doi: 10.1016/j.injury.2013.09.034. Epub 2013 Sep 27.

  PMID: 24125537 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2013
• First Posted: April 23, 2013
• Study Start: March 1, 2008
• Primary Completion: September 1, 2011
• Study Completion: March 1, 2013
• Last Updated: April 23, 2013

Record last verified: 2011-06

Locations

CN (1)