Bone Substitute in the Multi Traumatized Nasal Septum Reconstruction (NASEPT)
The aim of this project is to evaluate the safety and efficacy of the biomaterial made of HAP/TCP (BCP, Kasios®), in septoplasties of multi traumatized human nose. The use of this biomaterial will avoid the graft sampling and we expect it to be a good substitute to support the nasal pyramid while favouring the respiratory epithelium regeneration. Thus, that would confirm previous in vitro and in vivo studies.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Multicentric Pilot, Clinical Study of a Bone Substitute Safety and Efficacy in the Multi Traumatized Nasal Septum Reconstruction|
- Safety [ Time Frame: up to 6 months after surgery ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]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. ] [ Designated as safety issue: No ]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. ] [ Designated as safety issue: No ]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.
|Study Start Date:||September 2011|
|Study Completion Date:||November 2014|
|Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
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.
Five to ten percent of the post-traumatic septo-rhinoplasties require a total reconstruction of the septal skeleton. This surgery requires using autologous bone graft (iliac, costal, or parietal). However these swabs include surgical risks, have a particular morbidity non negligible and particular quality imperfections (resorption level, texture, shape, integration) requiring a complex and long lasting shaping before implantation. To avoid the using of bone graft, a large scale of products has been developed to propose a synthetic bone substitute as a support for bone reconstruction. The bone substitute, BCP, made of hydroxyl apatite (HAP) and tricalcium phosphate (TCP), is thus largely used in orthopaedics, and CE marked in numerous indications (like sinus lift). The stake is to validate that it can be used in septo-rhino-plasties. This septic zone presents characteristics which required in vitro and in vivo studies, showing that the conclusions are a good biocompatibility of BCP for human epithelial cells and in septal area of rabbits and sheep. The ultimate step to validate this concept consists in conducting a pilot clinical study on 25 patients with the indication of septoplasties to verify its safety and efficacy in clinical conditions. This study will have an 18 months inclusion period and 6 months of follow up. The principal objective is to assess the HAP/TCP biomaterial safety and to confirm clinically and histologically the good affinity of human epithelial cells for this material. Secondary objective is to demonstrate that the restoration of the normal nasal anatomy with the material re-establishes the nasal respiratory shape and function. Clinical data, questionnaires, and photos will be collected pre operatively and at day 4, 10, and month 2 and 6 after surgery. The endonasal biopsy and fiberoptic endoscopy will be realised at 2 and 6 months post operatively and will be supplementary to the routine care protocol of the surgeon.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01234415
|Service d'Oto-rhino-laryngologie - Clinique St Augustin|
|Bordeaux, France, 33074|
|Service d'Oto-rhino-laryngologie et Chirurgie cervico-faciale - CHU de Bordeaux|
|Bordeaux, France, 330176|
|Service d'Oto-rhino-laryngologie - Hôpital Dupuytren|
|Limoges, France, 87042|
|Principal Investigator:||Ludovic LE TAILLANDIER de GABORY, Dr||CHU Bordeaux|