Safety Profile of Applied 100% Manuka Honey in Tympanoplasty

Phase 2

Completed

• Conditions: Chronic Suppurative Otitis Media; Tympanic Membrane; Wound
• Interventions: Drug: Manukamed - Manukapli 100% sterile honey wound dressing - Premium medical grade 16+ Leptospermum Scoparium New Zealand honey

• Registration Number: NCT05657717
• Lead Sponsor: Fakultas Kedokteran Universitas Indonesia

Brief 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.

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 Timeline

• Study Start: 2021-07-13
• Primary Completion: 2022-09-29
• Study Completion: 2022-09-29
• Status Verified: 2022-12
• Study First Submitted: 2022-12-02
• Study First Submitted QC: 2022-12-11
• Last Update Submitted: 2022-12-11
• Study First Posted: 2022-12-20
• Last Update Posted: 2022-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Manukamed - Manukapli 100% sterile honey wound dressing - Premium medical grade 16+ Leptospermum Scoparium New Zealand honey	Manukamed - 100% sterile manuka honey

Primary Outcome Measures

Name	Time	Method
Evaluation of Ototoxicity - BERA	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.
Evaluation of Ototoxicity - Audiometry	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.

Secondary Outcome Measures

Name	Time	Method
Evaluation of Ototoxicity - Symptoms - Tinnitus	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.
Evaluation of Ototoxicity - Symptoms - Hearing Loss	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.
Evaluation of Ototoxicity - Symptoms - Dysequilibrium	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.

Trial Locations

Locations (1)

Faculty of Medicine - University of Indonesia; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia