CompletedPhase 2/3

Safety Profile of Applied 100% Manuka Honey in Tympanoplasty

Indonesia64 participantsStarted 2021-07-13

Plain-language summary

Throughout history, honey has been recognized for its healing properties. The use of honey for its medicinal properties dates back to 2200 BCE. The purpose of this clinical trial is to learn about the otological safety of 100% Medical grade Manuka Honey given to tympanoplasty patients The main question it aims to answer is: Can 100% Medical Grade Manuka Honey given at the time of Tympanoplasty otologically safe? Participants in the intervention group will receive a wound dressing of 100% medical grade Manuka honey after reconstructive surgery of the tympanic membrane. Researchers will compare the intervention group to the control group assess otological safety.

Who can participate

Age range18 Years – 45 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Participants of 18 - 45 years of age. * Participants with Chronic Suppurative Otitis Media of the mucosal type. * Provision of signed and dated informed consent form. Stated willingness to comply with all study procedures and availability for the duration of the study. Exclusion Criteria: * Participants who previously received surgical therapy for Chronic Suppurative Otitis Media or have recurrent or residual disease. * Participants with anatomical pathology results showing and/or suspecting a tumor.

What they're measuring

Evaluation of Ototoxicity - BERA

Timeframe: Time Frame: 5 weeks (35 days following surgery)

Evaluation of Ototoxicity - Audiometry

Timeframe: Time Frame: 6 weeks (42 days following surgery)

Trial details

NCT IDNCT05657717

SponsorFakultas Kedokteran Universitas Indonesia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-09-29

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