NASEPT: Bone Substitute in the Multi Traumatized Nasal Septum Reconstruction

Sponsor

University Hospital, Bordeaux (Other)

Overall Status

Completed

CT.gov ID

NCT01234415

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

8.7

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Nasal Septum	Device: Rhinoplasty	Phase 2

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). 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

26 participants

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Sep 1, 2011

Actual Primary Completion Date :

Nov 1, 2014

Actual Study Completion Date :

Nov 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patient	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.

Arm

Intervention/Treatment

Experimental: Patient

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.

Outcome Measures

Primary Outcome Measures

Safety [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 [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.

Secondary Outcome Measures

Performance with Internal and external nasal shape assessment [month 2 and 6 after surgery.]
Photography and fiberoptic endoscopy
Performance with Functional Performance Assessment [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
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

Sponsors and Collaborators

University Hospital, Bordeaux

Investigators

Principal Investigator: Ludovic LE TAILLANDIER de GABORY, Dr, CHU Bordeaux

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Bordeaux

ClinicalTrials.gov Identifier:

NCT01234415

Other Study ID Numbers:

CHUBX 2010/16

First Posted:

Nov 4, 2010

Last Update Posted:

Mar 18, 2015

Last Verified:

Mar 1, 2015

Keywords provided by University Hospital, Bordeaux

nasal

septum

reconstruction

Study Results

No Results Posted as of Mar 18, 2015