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

RecruitingOBSERVATIONAL
Enrollment

70

Participants

Timeline

Start Date

September 29, 2023

Primary Completion Date

March 31, 2026

Study Completion Date

April 30, 2027

Conditions
Cholesteatoma
Interventions
DEVICE

verre bioactif 45S5 GlassBONE

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.

DEVICE

verre bioactif S53P4 Bonalive

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.

Trial Locations (1)

69495

RECRUITING

Hôpital Lyon Sud, Lyon

All Listed Sponsors
lead

Centre Hospitalier Intercommunal Creteil

OTHER