NCT03701685

Brief Summary

A retrospective study is conducted with 59 patients who has a combination of soft tissue and digital nerve defects following trauma treated using the Littler flap or bipedicle nerve flap.Patients are divided into two groups. The group reconstructed with the Litter flap includes 26 patients and the group reconstructed with the bipedicle nerve flap includes 33 patients.Discriminatory sensation, pain and cold intolerance of the reconstructed finger, and patient satisfaction were evaluated.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2008

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

October 8, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 10, 2018

Completed
Last Updated

October 15, 2018

Status Verified

August 1, 2018

Enrollment Period

7.6 years

First QC Date

October 8, 2018

Last Update Submit

October 12, 2018

Conditions

Keywords

nerve flapsensory reconstructionnerve repair

Outcome Measures

Primary Outcomes (1)

  • Static 2PD test

    We use a Disk-Criminator to test two nearby points when touching the flap. It is often

    18 months to 24 months after surgery

Study Arms (1)

nerve grafting

OTHER

The stumps of digital nerve are connected with nerve graft

Procedure: nerve flap

Interventions

nerve flapPROCEDURE

sensory reconstruction via a nerve graft included in the flap

nerve grafting

Eligibility Criteria

Age15 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • the defect in a region where sensory return is considered important
  • soft tissue defect with exposed bone or tendon in only one digit
  • associated single or double digital nerve defects with 1 to 4 cm in length7
  • a soft tissue defect greater than 1.5 cm and less than 4 cm in length
  • necessity to preserve digit length
  • a patient between 15 and 60 years of age.

You may not qualify if:

  • injury to the course of donor arterial pedicle or donor nerve
  • nerve defect less than 1 cm or larger than 4 cm
  • a soft tissue defect≤1.5 cm or ≥4 cm in length
  • multiple-digit soft tissue defects
  • extremely contaminated wounds
  • the defect in a region the flap is unable to reach, such as thumb fingertip

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Chen C, Tang P, Zhang L. Use of a bipedicled nerve flap taken from the dorsum of the digit for reconstruction of neurocutaneous defect in the adjacent finger. J Plast Reconstr Aesthet Surg. 2013 Oct;66(10):1322-9. doi: 10.1016/j.bjps.2013.06.001. Epub 2013 Jul 2.

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

October 8, 2018

First Posted

October 10, 2018

Study Start

July 1, 2008

Primary Completion

February 1, 2016

Study Completion

May 1, 2016

Last Updated

October 15, 2018

Record last verified: 2018-08