Bone Substitute in the Multi Traumatized Nasal Septum Reconstruction

PHASE2CompletedINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

September 30, 2011

Primary Completion Date

November 30, 2014

Study Completion Date

November 30, 2014

Conditions
Nasal Septum
Interventions
DEVICE

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.

Trial Locations (3)

33074

Service d'Oto-rhino-laryngologie - Clinique St Augustin, Bordeaux

87042

Service d'Oto-rhino-laryngologie - Hôpital Dupuytren, Limoges

330176

Service d'Oto-rhino-laryngologie et Chirurgie cervico-faciale - CHU de Bordeaux, Bordeaux

All Listed Sponsors
lead

University Hospital, Bordeaux

OTHER

NCT01234415 - Bone Substitute in the Multi Traumatized Nasal Septum Reconstruction | Biotech Hunter | Biotech Hunter