Bone Substitute in the Multi Traumatized Nasal Septum Reconstruction (NASEPT)
|ClinicalTrials.gov Identifier: NCT01234415|
Recruitment Status : Completed
First Posted : November 4, 2010
Last Update Posted : March 18, 2015
|Condition or disease||Intervention/treatment||Phase|
|Nasal Septum||Device: Rhinoplasty||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multicentric Pilot, Clinical Study of a Bone Substitute Safety and Efficacy in the Multi Traumatized Nasal Septum Reconstruction|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||November 2014|
Rhinoplasty is performed under general anaesthesia; the duration is 1 to 2 hours. The surgical approach for implantation of the biomaterial is external rhinoplasty. The incision is made at the columella (base of nose) and becomes internal for the scar to be as unobtrusive as possible. The septum skeleton is then destroyed in order to place the synthetic biomaterial. The biomaterial is remodelled in order to have a natural external aspect of the nose. The incision is closed and the wicks are put in place in the nose for 4 days. A cast and a sticker will be put in place after surgery to maintain properly the biomaterial.
- Safety [ Time Frame: up to 6 months after surgery ]Frequency and severity of expected Adverse and Severe Adverse Events, as material extrusion, infection (wall abscess), and chronic pathological inflammatory reaction, pain, epistaxis.
- Epithelial cells affinity [ Time Frame: up to 6 months after surgery ]macroscopic mucous membrane integrity (ciliated cells), absence of perforation, pathological analyses of biopsy to research sub epithelial infiltration, respiratory epithelial differentiation markers (HES, MOVAT pentachrome), immunohistochemistry (AB against cytokeratines 7, 8, 19, UEA1, MUC5AC) and MEB, MET analyses.
- Performance with Internal and external nasal shape assessment [ Time Frame: month 2 and 6 after surgery. ]Photography and fiberoptic endoscopy
- Performance with Functional Performance Assessment [ Time Frame: pre operatively and post operatively at day 4, 10, and month 2 and 6 after surgery. ]NOSE and RHINO quality of life questionnaires Clinical data, questionnaires, and photos will be collected pre operatively and post operatively at day 4, 10, and month 2 and 6 after surgery.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01234415
|Service d'Oto-rhino-laryngologie et Chirurgie cervico-faciale - CHU de Bordeaux|
|Bordeaux, France, 330176|
|Service d'Oto-rhino-laryngologie - Clinique St Augustin|
|Bordeaux, France, 33074|
|Service d'Oto-rhino-laryngologie - Hôpital Dupuytren|
|Limoges, France, 87042|
|Principal Investigator:||Ludovic LE TAILLANDIER de GABORY, Dr||CHU Bordeaux|