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Evaluation of the effectiveness of Boric Acid in an ear dressing for the treatment of an infectious process in temporal bone cavities

Evaluation of the effectiveness of Boric Acid in otological bandage for treatment of infectious process in mastoid cavities: randomized and blind clinical study

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
REBEC
Registry ID
RBR-7m7yjdj
Enrollment
Unknown
Registered
2023-07-20
Start date
2023-06-24
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

Other postprocedural disorders of ear and mastoid process

Interventions

The study will be carried out at the Otology Service of the Hospital das Clínicas de Ribeirão Preto, Faculty of Medicine of Ribeirão Preto, University of São Paulo (HCRP-FMRP-USP), located at the Spec

Sponsors

Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Lead Sponsor
Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Has been subjected to Wall Down mastoidectomy; is presenting active infectious framework at the moment

Exclusion criteria

Exclusion criteria: Is using topical and/or systemic antibiotic therapy; Cholesteatoma recurrence diagnosis; has been subjected to mastidectomy wall up

Design outcomes

Primary

MeasureTime frame
To assess whether ciplofloxacin and dexamethasone ointment associated with 1% boric acid powder improves otalgia, otorrhea, hyperemia and the presence of polyp in the treatment of an infectious condition in patients undergoing Wall down mastoidectomy. A clinical score on these parameters is used, with a score of zero being expected at the end of treatment;Is the dressing with ciplofloxacin and dexamethasone ointment associated with 1% boric acid powder more effective when compared to ciprofloxacin and dexamethasone ointment alone in the treatment of acute chronic otitis media in patients undergoing Wall down mastoidectomy?

Secondary

MeasureTime frame
To assess whether ciplofloxacin ointment associated with 1% boric acid powder reduces treatment time and the number of dressings needed to resolve the infection in patients undergoing Wall down mastoidectomy.;Document possible side effects of these treatments.

Countries

Brazil

Contacts

Public ContactBento;Eduardo Segundo;Massuda

Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo;Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo

bblrsegundo@hcrp.usp.br;edumassuda@fmrp.usp.br+55(16)36022321;+55(16)36022994

Outcome results

None listed

Source: REBEC (via WHO ICTRP)