Safety Profile of Applied 100% Manuka Honey in Tympanoplasty
December 11, 2022 updated by: Fakultas Kedokteran Universitas Indonesia
Otological Safety Profile of 100% Manuka Honey Application in Tympanoplasty: A Double-blinded Randomized Controlled Trial
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.
Study Overview
Status
Completed
Detailed Description
The aim of the present study is to conduct a randomized clinical trial to evaluate the otological safety of 100% medical grade Manuka honey on the tympanic membrane post Tympanoplasty compared to the control group.
The investigation will involve 64 participants with Chronic Suppurative Otitis Media of the mucosal type, who will be randomly put into two groups (intervention or control), where the intervention group will receive a dressing of 100% sterile Manuka honey during surgery.
Results of this study will inform practitioners as to the otological safety of 100% sterile Manuka honey on the tympanic membrane.
Study Type
Interventional
Enrollment (Actual)
64
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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DKI Jakarta
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Jakarta Pusat, DKI Jakarta, Indonesia, 10430
- Faculty of Medicine - University of Indonesia
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 41 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
Manukamed - 100% sterile manuka 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 Names:
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No Intervention: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation of Ototoxicity - BERA
Time Frame: Time Frame: 5 weeks (35 days following surgery)
|
Hearing function will be evaluated by conducting a Brain Evoked Response Audiometry (BERA) exam.
If the BERA results show decreased stimulus of more than 10 decibels compared to baseline, treatment is started immediately.
|
Time Frame: 5 weeks (35 days following surgery)
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Evaluation of Ototoxicity - Audiometry
Time Frame: Time Frame: 6 weeks (42 days following surgery)
|
Hearing function will be evaluated by conducting a Pure Tone Audiometry exam.
Results are compared to baseline and evaluated.
If there is a 20db or greater decrease in pure-tone threshold at one frequency or 10db or greater decreased at 2 adjacent frequencies, treatment is started immediately.
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Time Frame: 6 weeks (42 days following surgery)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation of Ototoxicity - Symptoms - Tinnitus
Time Frame: Time Frame: 6 weeks (42 days following surgery)
|
Participants will be asked to complete a questionnaire regarding tinnitus.
Subjective symptoms are measured using a visual analog scale ranging from 1-10, with higher scores indicating worse symptoms.
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Time Frame: 6 weeks (42 days following surgery)
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Evaluation of Ototoxicity - Symptoms - Hearing Loss
Time Frame: Time Frame: 6 weeks (42 days following surgery)
|
Participants will be asked to complete a questionnaire regarding hearing loss.
Subjective symptoms are measured using a visual analog scale ranging from 1-10, with higher scores indicating worse symptoms.
|
Time Frame: 6 weeks (42 days following surgery)
|
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Evaluation of Ototoxicity - Symptoms - Dysequilibrium
Time Frame: Time Frame: 6 weeks (42 days following surgery)
|
Participants will be asked to complete a questionnaire regarding dysequilibrium.
Subjective symptoms are measured using a visual analog scale ranging from 1-10, with higher scores indicating worse symptoms.
|
Time Frame: 6 weeks (42 days following surgery)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Harim Priyono, Faculty of Medicine, University of Indonesia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 13, 2021
Primary Completion (Actual)
September 29, 2022
Study Completion (Actual)
September 29, 2022
Study Registration Dates
First Submitted
December 2, 2022
First Submitted That Met QC Criteria
December 11, 2022
First Posted (Actual)
December 20, 2022
Study Record Updates
Last Update Posted (Actual)
December 20, 2022
Last Update Submitted That Met QC Criteria
December 11, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21040426
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
If requested, data records without identifying patient information can be shared
IPD Sharing Time Frame
Data will be available not more than 6 months after study completion date
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.