NCT05605262

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

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Fakultas Kedokteran Universitas Indonesia · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Otitis Media, Suppurative
• Tympanic Membrane Perforation

Interventions

Type	Name	Description
DRUG	Manukamed - Manukapli 100% sterile honey wound dressing - Premium medical grade 16+ Leptospermum Scoparium New Zealand 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.

Timeline

• Start date: 2021-06-13
• Primary completion: 2022-09-29
• Completion: 2022-09-29
• First posted: 2022-11-04
• Last updated: 2022-11-04

Locations

1 site across 1 country: Indonesia

Regulatory

• FDA-regulated drug study