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Bone Substitute in the Multi Traumatized Nasal Septum Reconstruction
Sponsor: University Hospital, Bordeaux
Summary
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.
Official title: Multicentric Pilot, Clinical Study of a Bone Substitute Safety and Efficacy in the Multi Traumatized Nasal Septum Reconstruction
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
26
Start Date
2011-09
Completion Date
2014-11
Last Updated
2026-05-14
Healthy Volunteers
No
Conditions
Interventions
Rhinoplasty
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.
Locations (3)
Service d'Oto-rhino-laryngologie et Chirurgie cervico-faciale - CHU de Bordeaux
Bordeaux, France
Service d'Oto-rhino-laryngologie - Clinique St Augustin
Bordeaux, France
Service d'Oto-rhino-laryngologie - Hôpital Dupuytren
Limoges, France