Safety Profile of Applied 100% Manuka Honey in Tympanoplasty
NCT ID: NCT05657717
Last Updated: 2022-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
64 participants
INTERVENTIONAL
2021-07-13
2022-09-29
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Intervention
Manukamed - 100% sterile manuka honey
Manukamed - Manukapli 100% sterile honey wound dressing - Premium medical grade 16+ Leptospermum Scoparium New Zealand honey
After surgical reconstruction of the tympanic membrane by grafting, Manukamed - Manukapli 100% Sterile honey wound dressing is applied onto the gelfoam to close the area, followed by an antibiotic tampon.
Control
No intervention was given. Participants receive standard wound care of the tympanic membrane which includes 0.3% Ofloxacin otic ear drops which were used twice a day for 5 days.
No interventions assigned to this group
Interventions
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Manukamed - Manukapli 100% sterile honey wound dressing - Premium medical grade 16+ Leptospermum Scoparium New Zealand honey
After surgical reconstruction of the tympanic membrane by grafting, Manukamed - Manukapli 100% Sterile honey wound dressing is applied onto the gelfoam to close the area, followed by an antibiotic tampon.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 with anatomical pathology results showing and/or suspecting a tumor.
18 Years
45 Years
ALL
No
Sponsors
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Fakultas Kedokteran Universitas Indonesia
OTHER
Responsible Party
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Principal Investigators
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Harim Priyono
Role: PRINCIPAL_INVESTIGATOR
Faculty of Medicine, University of Indonesia
Locations
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Faculty of Medicine - University of Indonesia
Jakarta Pusat, DKI Jakarta, Indonesia
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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21040426
Identifier Type: -
Identifier Source: org_study_id