Bone Substitute in the Multi Traumatized Nasal Septum Reconstruction (NASEPT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by University Hospital, Bordeaux
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT01234415
First received: November 2, 2010
Last updated: August 19, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Nasal Septum
Device: Rhinoplasty
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 25
Study Start Date: September 2011
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01234415

Contacts
Contact: Ludovic LE TAILLANDIER de GABORY, Dr ludovic.de-gabory@chu-bordeaux.fr

Locations
France
Service d'Oto-rhino-laryngologie - Clinique St Augustin Recruiting
Bordeaux, France, 33074
Principal Investigator: Philippe BOUDARD, Dr         
Service d'Oto-rhino-laryngologie et Chirurgie cervico-faciale - CHU de Bordeaux Recruiting
Bordeaux, France, 330176
Contact: Ludovic LE TAILLANDIER de GABORY, Dr         
Principal Investigator: Ludovic LE-TAILLANDIER-DE-GABORY, Dr         
Sub-Investigator: Dominique STOLL, Pr         
Service d'Oto-rhino-laryngologie - Hôpital Dupuytren Recruiting
Limoges, France, 87042
Principal Investigator: Jean-Pierre BESSEDE, Pr         
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Principal Investigator: Ludovic LE TAILLANDIER de GABORY, Dr CHU Bordeaux
  More Information

No publications provided

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT01234415     History of Changes
Other Study ID Numbers: CHUBX 2010/16
Study First Received: November 2, 2010
Last Updated: August 19, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Bordeaux:
nasal
septum
reconstruction

ClinicalTrials.gov processed this record on October 29, 2014