Completed

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

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What is being tested

Composite Flap

Procedure
Who is being recruted

From 15 to 55 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: March 2008
See protocol details

Summary

Principal SponsorThe Second Hospital of Tangshan
Last updated: April 23, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2008

Actual date on which the first participant was enrolled.

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.

NCT01837407
Principal SponsorThe Second Hospital of Tangshan
Last updated: April 23, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

9 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 15 to 55 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

2 inclusion criteria required to participate
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

3 exclusion criteria prevent from participating
a nerve injury that is able to be repaired by primary neurorrhaphy

a soft tissue defect on the noncontiguous lateral aspects of adjacent fingers

an injury involving the course of the arterial or venous pedicle; an injury involving donor site or donor nerve

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

The Second Hospital of Tangshan

Tangshan, ChinaOpen The Second Hospital of Tangshan in Google Maps
CompletedOne Study Center