NCT01826539

Brief Summary

As the donor nerve attached with the flap, the dorsal branch of the digital nerve and the dorsal digital nerve is commonly used for finger pulp reconstruction.This study compares two donor nerves: the dorsal branch of the digital nerve and the dorsal digital nerve.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

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

January 1, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 8, 2013

Completed
Last Updated

April 8, 2013

Status Verified

April 1, 2011

Enrollment Period

1.1 years

First QC Date

April 1, 2013

Last Update Submit

April 5, 2013

Conditions

Soft Tissue Defect of the Finger

Keywords

Dorsal digital nervedorsal branch of the digital nervedorsal branch of the digital arterydorsal digital island flapfinger pulp defect.

Outcome Measures

Primary Outcomes (1)

  • static 2-point discrimination (2PD) 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. We stop at 4mm as a limit of 2PD and consider this normal.

    18 months to 26 months

Secondary Outcomes (1)

  • Cold intolerance

    18 months to 26 months

Other Outcomes (1)

  • Pain

    18 months to 26 months

Study Arms (1)

Innervated finger flap

OTHER

donor nerve attached with the flap for finger pulp reconstruction

Procedure: flap includes a donor nerve

Interventions

flap includes a donor nervePROCEDURE

the donor nerve is attached with the flap for sensory reconstruction of the finger

Innervated finger flap

Eligibility Criteria

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

You may qualify if:

  • The pulp or fingertip defect in only one finger
  • A defect greater than or equal to 1.5 cm in length
  • Necessity to preserve finger length
  • A patient between 18 and 60 years of age

You may not qualify if:

  • Injuries to the dorsum of the middle phalanx
  • Injuries to the course of the vascular pedicle or donor nerve
  • A defect less than 1.5 cm in length
  • Multiple finger pulp defect
  • Extremely contaminated wounds

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Hospital of Tangshan

Tangshan, Hebei, 063000, China

Location

Related Publications (1)

  • Chen C, Tang P, Zhang X. Use of the dorsal digital sensate free flap for reconstruction of volar soft tissue defect of digits. Ann Plast Surg. 2014 May;72(5):537-41. doi: 10.1097/SAP.0b013e318268a97f.

    PMID: 23241796RESULT

Study Officials

  • Dequn Liu, MD. PhD

    The Second Hospital of Tangshan

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

April 1, 2013

First Posted

April 8, 2013

Study Start

January 1, 2011

Primary Completion

February 1, 2012

Study Completion

September 1, 2012

Last Updated

April 8, 2013

Record last verified: 2011-04

Locations

CN(1)