Bone Substitute in the Multi Traumatized Nasal Septum Reconstruction

NCT01234415 | Completed Phase 2 DMC

• 1 other identifier: CHUBX 2010/16
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 3

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.

Conditions

Nasal Septum

Keywords

nasal; septum; reconstruction

Outcome Measures

Primary Outcomes (2)

• Safety

  Frequency and severity of expected Adverse and Severe Adverse Events, as material extrusion, infection (wall abscess), and chronic pathological inflammatory reaction, pain, epistaxis.

  up to 6 months after surgery

• Epithelial cells affinity

  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.

  up to 6 months after surgery

Secondary Outcomes (2)

• Performance with Internal and external nasal shape assessment

  month 2 and 6 after surgery.

• Performance with Functional Performance Assessment

  pre operatively and post operatively at day 4, 10, and month 2 and 6 after surgery.

Study Arms (1)

Patient

EXPERIMENTAL

Device: Rhinoplasty

Interventions

Rhinoplasty DEVICE

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.

Patient

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (3)

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

Bordeaux, 330176, France

Location

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

Bordeaux, 33074, France

Location

Service d'Oto-rhino-laryngologie - Hôpital Dupuytren

Limoges, 87042, France

Location

MeSH Terms

Interventions

Rhinoplasty

Intervention Hierarchy (Ancestors)

Cosmetic Techniques; Therapeutics; Nasal Surgical Procedures; Otorhinolaryngologic Surgical Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures

Study Officials

• Ludovic LE TAILLANDIER de GABORY, Dr

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2010
• First Posted: November 4, 2010
• Study Start: September 1, 2011
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: March 18, 2015

Record last verified: 2015-03

Locations

FR (3)