Safety Profile of Applied 100% Manuka Honey in Tympanoplasty

Chronic Suppurative Otitis Media Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05657717
• Other study ID #: 21040426
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: July 13, 2021
• Est. completion date: September 29, 2022

Study information

• Verified date: December 2022
• Source: Fakultas Kedokteran Universitas Indonesia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: September 29, 2022
• Est. primary completion date: September 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Suppurative Otitis Media
• Otitis
• Otitis Media
• Otitis Media, Suppurative

Intervention

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.

Locations

Country	Name	City	State
Indonesia	Faculty of Medicine - University of Indonesia	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Fakultas Kedokteran Universitas Indonesia

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)