Safety Profile of Applied 100% Manuka Honey in Tympanoplasty

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Otological Safety Profile of 100% Manuka Honey Application in Tympanoplasty: A Double-blinded Randomized Controlled Trial

Conditions
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Chronic Suppurative Otitis Media, Tympanic Membrane; Wound

Intervention / Treatment
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* Drug: Manukamed - Manukapli 100% sterile honey wound dressing - Premium medical grade 16+ Leptospermum Scoparium New Zealand honey


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Manukamed - 100% sterile manuka honey | Drug: Manukamed - Manukapli 100% sterile honey wound dressing - Premium medical grade 16+ Leptospermum Scoparium New Zealand honey<br>* 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.<br>* Other names: Manukamed - Manukapli 100% sterile honey wound dressing;|
| No Intervention: Control<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Ototoxicity - BERA | 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) | 
| Evaluation of Ototoxicity - Audiometry | 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. | Time Frame: 6 weeks (42 days following surgery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Ototoxicity - Symptoms - Tinnitus | 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. | Time Frame: 6 weeks (42 days following surgery) | 
| Evaluation of Ototoxicity - Symptoms - Hearing Loss | 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) | 
| Evaluation of Ototoxicity - Symptoms - Dysequilibrium | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Suppurative Otitis Media, Manuka Honey, Tympanic Membrane, Otologic Safety