Short- and Medium-term Evaluation of Mastoid Filling Using Bioactive Glass"

ConditionCholesteatoma

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorCentre Hospitalier Intercommunal Creteil

About this trial

Adult patients referred to the ENT surgery department of the Hospices Civils de Lyon with cholesteatoma that had never been operated on.

All patients will benefit from surgical management for cholesteatoma initially in the operating room under general anesthesia. The surgical technique (closed technique) is the reference technique for the management of cholesteatoma in adults. It involves a cartilaginous removal to reconstruct the attical region. Then a filling material is used to fill the mastoid (GlassBONE™ or Bonalive™), and above all to stabilize the cartilaginous fragment to prevent a recurrence.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients at least 18 years old

Patients with proven cholesteatoma

Patient requiring and agreeing to surgery with filling of the mastoid or tympanic epi (closed technique with filling)

Patient having a surgery with filling in first intention

Disqualifiers

Known outer, middle or inner ear malformation

Congenital cholesteatoma

Previously operated cholesteatoma

Cholesteatoma requiring an open technique or presenting with chronic non-cholesteatomatous otitis

Trial population

Adult patients referred to the ENT surgery department of the Hospices Civils de Lyon with cholesteatoma that had never been operated on. All patients will benefit from surgical management for cholesteatoma initially in the operating room under general anesthesia. The surgical technique (closed technique) is the reference technique for the management of cholesteatoma in adults. It involves a cartilaginous removal to reconstruct the attical region. Then a filling material is used to fill the mastoid (GlassBONE™ or Bonalive™), and above all to stabilize the cartilaginous fragment to prevent a recurrence.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

verre bioactif 45S5 GlassBONE
Device
All patients will benefit from surgical management for a first stage cholesteatoma in the operating room under general anesthesia. The surgical technique (closed technique) is the reference technique for the management of cholesteatoma in adults. It involves a cartilaginous removal to reconstruct the attical region. Then a filling material is used to fill the mastoid (GlassBONE™ or Bonalive™), and above all to stabilize the cartilaginous fragment to prevent a recurrence. The mastoid filler used is left to the discretion and habits of the surgeon.
verre bioactif S53P4 Bonalive
Device
All patients will benefit from surgical management for a first stage cholesteatoma in the operating room under general anesthesia. The surgical technique (closed technique) is the reference technique for the management of cholesteatoma in adults. It involves a cartilaginous removal to reconstruct the attical region. Then a filling material is used to fill the mastoid (GlassBONE™ or Bonalive™), and above all to stabilize the cartilaginous fragment to prevent a recurrence. The mastoid filler used is left to the discretion and habits of the surgeon.

Treatment groups

70 Participants

are divided into 1 treatment group

Group A: patient with cholesteatoma who has never been operated on2 interventions

Trial outcomes

Primary outcomes

mastoid filling

A patient will be considered as a responder if the proportion of mastoid filling at 6 months is strictly greater than 70% compared to the reference measurement

Time frame

6 month

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Hospitalier Intercommunal Creteil

Lead sponsor

Source ClinicalTrials.gov

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