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

November 2, 2010
August 19, 2014
September 2011
March 2015   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01234415 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Bone Substitute in the Multi Traumatized Nasal Septum Reconstruction
Multicentric Pilot, Clinical Study of a Bone Substitute Safety and Efficacy in the Multi Traumatized Nasal Septum Reconstruction

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.

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.

Interventional
Phase 2
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Nasal Septum
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.
Experimental: Patient
Intervention: Device: Rhinoplasty
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
25
March 2015
March 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact: Ludovic LE TAILLANDIER de GABORY, Dr ludovic.de-gabory@chu-bordeaux.fr
France
 
NCT01234415
CHUBX 2010/16
Yes
University Hospital, Bordeaux
University Hospital, Bordeaux
Not Provided
Principal Investigator: Ludovic LE TAILLANDIER de GABORY, Dr CHU Bordeaux
University Hospital, Bordeaux
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP