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
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 design
Treatments tested in this trial
- verre bioactif 45S5 GlassBONE
- verre bioactif S53P4 Bonalive
Treatment groups
70 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov