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

Phase 2

Completed

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

• Registration Number: NCT05605262
• 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 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

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.

Study Timeline

• Study Start: 2021-06-13
• Primary Completion: 2022-09-29
• Study Completion: 2022-09-29
• Status Verified: 2022-10
• Study First Submitted: 2022-10-30
• Study First Submitted QC: 2022-10-30
• Last Update Submitted: 2022-10-30
• Study First Posted: 2022-11-04
• Last Update Posted: 2022-11-04

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.

Read More

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.

Read More

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
Weekly Evaluation of Tympanic Membrane Re-epithelialization Post-tympanoplasty	2 weeks (14 days following surgery)	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).

Secondary Outcome Measures

Name	Time	Method
Evaluation of Ototoxicity	5 weeks (35 days following surgery)	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.
Weekly Evaluation of Tympanic Membrane Re-epithelialization Post-tympanoplasty	6 weeks (42 days following surgery)	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).

Trial Locations

Locations (1)

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