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

Primary Purpose

Otitis Media, Suppurative, Tympanic Membrane Perforation

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 Otitis Media, Suppurative focused on measuring Chronic Suppurative Otitis Media, Manuka Honey, Wound Healing, Re-epithelialization, Tympanoplasty, Tympanic Membrane

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

Weekly Evaluation of Tympanic Membrane Re-epithelialization Post-tympanoplasty
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

Weekly Evaluation of Tympanic Membrane Re-epithelialization Post-tympanoplasty
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).
Weekly Evaluation of Tympanic Membrane Re-epithelialization Post-tympanoplasty
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).
Weekly Evaluation of Tympanic Membrane Re-epithelialization Post-tympanoplasty
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).
Weekly Evaluation of Tympanic Membrane Re-epithelialization Post-tympanoplasty
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).
Evaluation of Ototoxicity
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.

Full Information

First Posted
October 30, 2022
Last Updated
October 30, 2022
Sponsor
Fakultas Kedokteran Universitas Indonesia
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1. Study Identification

Unique Protocol Identification Number
NCT05605262
Brief Title
Effects of 100% Medical Grade Manuka Honey on Tympanic Membrane Reconstruction Healing.
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
June 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Otitis Media, Suppurative, Tympanic Membrane Perforation
Keywords
Chronic Suppurative Otitis Media, Manuka Honey, Wound Healing, Re-epithelialization, Tympanoplasty, Tympanic Membrane

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
Weekly Evaluation of Tympanic Membrane Re-epithelialization Post-tympanoplasty
Description
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).
Time Frame
2 weeks (14 days following surgery)
Secondary Outcome Measure Information:
Title
Weekly Evaluation of Tympanic Membrane Re-epithelialization Post-tympanoplasty
Description
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).
Time Frame
3 weeks (21 days following surgery)
Title
Weekly Evaluation of Tympanic Membrane Re-epithelialization Post-tympanoplasty
Description
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).
Time Frame
4 weeks (28 days following surgery)
Title
Weekly Evaluation of Tympanic Membrane Re-epithelialization Post-tympanoplasty
Description
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).
Time Frame
5 weeks (35 days following surgery)
Title
Weekly Evaluation of Tympanic Membrane Re-epithelialization Post-tympanoplasty
Description
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).
Time Frame
6 weeks (42 days following surgery)
Title
Evaluation of Ototoxicity
Description
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.
Time Frame
5 weeks (35 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
State/Province
DKI Jakarta
ZIP/Postal Code
10430
Country
Indonesia

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
If requested, data records without identifying patient information can be shared

Learn more about this trial

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

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