Safety Profile of Applied 100% Manuka Honey in Tympanoplasty

NCT05657717 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: 21040426
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Suppurative Otitis Media; Tympanic Membrane; Wound

Keywords

Chronic Suppurative Otitis Media; Manuka Honey; Tympanic Membrane; Otologic Safety

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (3)

• Evaluation of Ototoxicity - Symptoms - Tinnitus

  Time Frame: 6 weeks (42 days following surgery)

• Evaluation of Ototoxicity - Symptoms - Hearing Loss

  Time Frame: 6 weeks (42 days following surgery)

• Evaluation of Ototoxicity - Symptoms - Dysequilibrium

  Time Frame: 6 weeks (42 days following surgery)

Study Arms (2)

Intervention

EXPERIMENTAL

Manukamed - 100% sterile manuka honey

Drug: Manukamed - Manukapli 100% sterile honey wound dressing - Premium medical grade 16+ Leptospermum Scoparium New Zealand honey

Control

NO INTERVENTION

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.

Interventions

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

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.

Also known as: Manukamed - Manukapli 100% sterile honey wound dressing

Intervention

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fakultas Kedokteran Universitas Indonesia: lead

Study Sites (1)

Faculty of Medicine - University of Indonesia

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Harim Priyono

  Faculty of Medicine, University of Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2022
• First Posted: December 20, 2022
• Study Start: July 13, 2021
• Primary Completion: September 29, 2022
• Study Completion: September 29, 2022
• Last Updated: December 20, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available not more than 6 months after study completion date

Locations

ID (1)