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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta, DKI Jakarta, Indonesia, 10430
      • Faculty of Medicine - University of Indonesia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Manukamed - 100% sterile manuka honey	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.; Other Names: Manukamed - Manukapli 100% sterile honey wound dressing
No Intervention: Control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	2 weeks (14 days following surgery)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	3 weeks (21 days following surgery)
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).	4 weeks (28 days following surgery)
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).	5 weeks (35 days following surgery)
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).	6 weeks (42 days following surgery)
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.	5 weeks (35 days following surgery)

Collaborators and Investigators

• Sponsor: Fakultas Kedokteran Universitas Indonesia
• Investigators: Principal Investigator: Harim Priyono, Faculty of medicine, University of Indonesia

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2021
• Primary Completion (Actual): September 29, 2022
• Study Completion (Actual): September 29, 2022

Study Registration Dates

• First Submitted: October 30, 2022
• First Submitted That Met QC Criteria: October 30, 2022
• First Posted (Actual): November 4, 2022

Study Record Updates

• Last Update Posted (Actual): November 4, 2022
• Last Update Submitted That Met QC Criteria: October 30, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Wound Healing; Manuka Honey; Chronic Suppurative Otitis Media; Re-epithelialization; Tympanoplasty; Tympanic Membrane
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Inflammation; Wounds and Injuries; Otorhinolaryngologic Diseases; Ear Diseases; Otitis; Otitis Media; Suppuration; Otitis Media, Suppurative; Tympanic Membrane Perforation
• Other Study ID Numbers: 21040425

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: If requested, data records without identifying patient information can be shared

Drug and device information, study documents

• 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