Effects of 100% Medical Grade Manuka Honey on Tympanic Membrane Reconstruction Healing.

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 healing effects of 100% medical grade Manuka honey in participants with Chronic Suppurative Otitis Media of the mucosal type. The main question it aims to answer is: Can 100% Manuka honey given at the time of Tympanoplasty improve the re-epithelialization (healing process) of the tympanic membrane compared to controls? 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 to see healing process.

Detailed Description
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The aim of the present study is to conduct a randomized clinical trial to compare the effect of 100% sterile Manuka honey on re-epithelialization of 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 potential benefits of 100% sterile Manuka honey on the re-epithelialization of the tympanic membrane.

Official Title
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Effects of 100% Medical Grade Manuka Honey on Re-epithelialization Post Tympanoplasty in the Case of Mucosal Type Chronic Suppurative Otitis Media (CSOM) - A Prospective Double-blinded Randomized Controlled Trial

Conditions
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Otitis Media, Suppurative, Tympanic Membrane Perforation

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 |
| --- | --- | --- |
| Weekly Evaluation of Tympanic Membrane Re-epithelialization Post-tympanoplasty | Epithelialization of the tympanic membrane was measured using an indicator tool utilizing a filter paper (5 mm in width and 10 mm in length) with a water-based ink on one end as the indicator. Exposure of the indicator to the exudate on the surface of the tympanic membrane will reveal the status of the wound (wet/ dry). | 2 weeks (14 days following surgery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weekly Evaluation of Tympanic Membrane Re-epithelialization Post-tympanoplasty | Epithelialization of the tympanic membrane was measured using an indicator tool utilizing a filter paper (5 mm in width and 10 mm in length) with a water-based ink on one end as the indicator. Exposure of the indicator to the exudate on the surface of the tympanic membrane will reveal the status of the wound (wet/ dry). | 3 weeks (21 days following surgery) | 
| Weekly Evaluation of Tympanic Membrane Re-epithelialization Post-tympanoplasty | Epithelialization of the tympanic membrane was measured using an indicator tool utilizing a filter paper (5 mm in width and 10 mm in length) with a water-based ink on one end as the indicator. Exposure of the indicator to the exudate on the surface of the tympanic membrane will reveal the status of the wound (wet/ dry). | 4 weeks (28 days following surgery) | 
| Weekly Evaluation of Tympanic Membrane Re-epithelialization Post-tympanoplasty | Epithelialization of the tympanic membrane was measured using an indicator tool utilizing a filter paper (5 mm in width and 10 mm in length) with a water-based ink on one end as the indicator. Exposure of the indicator to the exudate on the surface of the tympanic membrane will reveal the status of the wound (wet/ dry). | 5 weeks (35 days following surgery) | 
| Weekly Evaluation of Tympanic Membrane Re-epithelialization Post-tympanoplasty | Epithelialization of the tympanic membrane was measured using an indicator tool utilizing a filter paper (5 mm in width and 10 mm in length) with a water-based ink on one end as the indicator. Exposure of the indicator to the exudate on the surface of the tympanic membrane will reveal the status of the wound (wet/ dry). | 6 weeks (42 days following surgery) | 
| Evaluation of Ototoxicity | Hearing function will be evaluated by conducting a Brain Evoked Response Audiometry exam. If the BERA results show decreased stimulus of more than 10 decibels, treatment for sudden deafness is started immediately. | 5 weeks (35 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, Wound Healing, Re-epithelialization, Tympanoplasty, Tympanic Membrane