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Ear cavity closure with frozen bone for otitis revision surgery

Mastoid cavity obliteration with particulated fresh frozen bone in revision surgery for patients with chronic otitis media with cholesteatoma

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-46st4w
Enrollment
Unknown
Registered
2016-01-06
Start date
2012-07-10
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Suppurative Otitis Média, Cholesteatoma

Interventions

Ten patients will undergo ear surgery for the removal of cholesteatoma and infection. Osseous depression behind the ear will be filled with particulated bone to prevent future infections. Post operati
Procedure/surgery
D008416

Sponsors

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Lead Sponsor
Anna Carolina de Oliveira Fonseca
Collaborator

Eligibility

Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Adults, with clinical indication of mastoidectomy revision surgery due to chronic otitis media.

Exclusion criteria

Exclusion criteria: diabetes, bone metabolism diseases, smokers, coagulation disorders

Design outcomes

Primary

MeasureTime frame
otorreha control evaluation or stop of ear discharge. Will be acessed in the patient's clinical exam. Qualitative parameter consists in a binary choice: yes or no.—

Secondary

MeasureTime frame
Osteointegration of the particulated fresh frozen bone in the mastoid cavity shown by computed tomography of the temporal bones performed 6 months after surgery. Radiological density could be: hyperdense, intermediate density or hipodense.—

Countries

Brazil

Contacts

Public ContactAnna Carolina Fonseca

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

annacfonseca@gmail.com+551126617834

Outcome results

None listed

Source: REBEC (via WHO ICTRP)