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Safety Profile of Applied 100% Manuka Honey in Tympanoplasty

Primary Purpose

Chronic Suppurative Otitis Media, Tympanic Membrane; Wound

Status
Completed
Phase
Phase 2
Locations
Indonesia
Study Type
Interventional
Intervention
Manukamed - Manukapli 100% sterile honey wound dressing - Premium medical grade 16+ Leptospermum Scoparium New Zealand honey
Sponsored by
Fakultas Kedokteran Universitas Indonesia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Suppurative Otitis Media focused on measuring Chronic Suppurative Otitis Media, Manuka Honey, Tympanic Membrane, Otologic Safety

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of Medicine - University of Indonesia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

Manukamed - 100% sterile manuka honey

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
December 2, 2022
Last Updated
December 11, 2022
Sponsor
Fakultas Kedokteran Universitas Indonesia
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1. Study Identification

Unique Protocol Identification Number
NCT05657717
Brief Title
Safety Profile of Applied 100% Manuka Honey in Tympanoplasty
Official Title
Otological Safety Profile of 100% Manuka Honey Application in Tympanoplasty: A Double-blinded Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
July 13, 2021 (Actual)
Primary Completion Date
September 29, 2022 (Actual)
Study Completion Date
September 29, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fakultas Kedokteran Universitas Indonesia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Suppurative Otitis Media, Tympanic Membrane; Wound
Keywords
Chronic Suppurative Otitis Media, Manuka Honey, Tympanic Membrane, Otologic Safety

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Manukamed - 100% sterile manuka honey
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Manukamed - Manukapli 100% sterile honey wound dressing - Premium medical grade 16+ Leptospermum Scoparium New Zealand honey
Other Intervention Name(s)
Manukamed - Manukapli 100% sterile honey wound dressing
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluation of Ototoxicity - BERA
Description
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
Time Frame: 5 weeks (35 days following surgery)
Title
Evaluation of Ototoxicity - Audiometry
Description
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
Time Frame: 6 weeks (42 days following surgery)
Secondary Outcome Measure Information:
Title
Evaluation of Ototoxicity - Symptoms - Tinnitus
Description
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
Time Frame: 6 weeks (42 days following surgery)
Title
Evaluation of Ototoxicity - Symptoms - Hearing Loss
Description
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
Time Frame: 6 weeks (42 days following surgery)
Title
Evaluation of Ototoxicity - Symptoms - Dysequilibrium
Description
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
Time Frame: 6 weeks (42 days following surgery)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harim Priyono
Organizational Affiliation
Faculty of Medicine, University of Indonesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine - University of Indonesia
City
Jakarta Pusat
State/Province
DKI Jakarta
ZIP/Postal Code
10430
Country
Indonesia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
If requested, data records without identifying patient information can be shared
IPD Sharing Time Frame
Data will be available not more than 6 months after study completion date

Learn more about this trial

Safety Profile of Applied 100% Manuka Honey in Tympanoplasty

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