Status:
COMPLETED
Bone Substitute in the Multi Traumatized Nasal Septum Reconstruction
Lead Sponsor:
University Hospital, Bordeaux
Conditions:
Nasal Septum
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief 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 avo...
Detailed Description
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). How...
Eligibility Criteria
Inclusion
- Men and women between 18 and 60
- Indication of tissue replacement in a nasal septum, which skeleton is lacking or non usable for patients having:
- Paradoxal nasal obstruction with saddle nose type III and IV or flabby nose
- Nasal obstruction with an obstacle caused by a moved multifracture skeleton
- Written informed consent
- Patient with social insurance
Exclusion
- Post-menopausal women : lack of efficient contraception (intra uterine dispositive or contraceptive pill)
- Breast feeding or pregnant women
- HIV or VHB or VHC seropositive subject
- Inflammatory or infectious active rhino sinusitis
- Nasal an sinus surgery or trauma ended from less than 8 months
- Toxic medicated Rhinitis to vasoconstrictors
- Diabetic : all type of diabetes (without or with therapy)
- Non treated cardiac disease
- Any contra indication to surgery
- Any contra indication to the biomaterial use like evolutive infection, bone disease or local necrosis
- Radiotherapy antecedent of the cephalic and cervical extremity
- Local or regional therapy with corticoids currently, or stopped from less than 2 months
- Patient participating to another study with an exclusion period still going on during pre-inclusion period
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01234415
Start Date
September 1 2011
End Date
November 1 2014
Last Update
March 18 2015
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Service d'Oto-rhino-laryngologie et Chirurgie cervico-faciale - CHU de Bordeaux
Bordeaux, France, 330176
2
Service d'Oto-rhino-laryngologie - Clinique St Augustin
Bordeaux, France, 33074
3
Service d'Oto-rhino-laryngologie - Hôpital Dupuytren
Limoges, France, 87042