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NCT03677349

Evaluation of the Interest of the Neurorrhaphy in Resensitizing Free Flaps

Status unknown NA Last updated 4 February 2019
What this trial tests

NA trial testing neurorrhaphy in Reconstructive Surgery After Carcinological Excision in 50 participants. Status unknown.

Timeline
16 July 2018
Primary endpoint
30 April 2021
30 April 2022

Quick facts

Lead sponsorUniversity Hospital, Clermont-Ferrand
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment50
Start date16 July 2018
Primary completion30 April 2021
Estimated completion30 April 2022
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

University Hospital, Clermont-Ferrand

Who can join

18 and older, any sex, with Reconstructive Surgery After Carcinological Excision. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The surgical procedure consists in removing a tumor of the oral cavity and then repairing the oral defect by the use of a free flap. A free flap is tissue composed of skin and aponeurosis taken from the thigh or forearm, or tissue composed of bone taken from the leg to fill in tissue loss. This tissue is vascularized by a vein and an artery that are removed with the flap to ensure its survival. Investigator would also like to harvest the nerve involved in the sensitivity of the skin flap to suture it to a nerve which will be located near the reconstructed area, and this to enhance sensitivity of the reconstructed oral cavity. Thanks to this, investigator also wish to highlight that this resensitization would improve the patient's quality of life particularly regarding his major oral functions (swallowing, phonation, sensation of cold and hot felt, chewing). Investigator therefore seek to demonstrate that suturing the nerve will give to the patient the ability back to feel tactile and thermal sensations This is the purpose of the study.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other University Hospital, Clermont-Ferrand trials

Trials by the same sponsor.

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Data sources for this page

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