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

NCT05605262 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: 21040425
• 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 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.

Conditions

Otitis Media, Suppurative; Tympanic Membrane Perforation

Keywords

Chronic Suppurative Otitis Media; Manuka Honey; Wound Healing; Re-epithelialization; Tympanoplasty; Tympanic Membrane

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Weekly Evaluation of Tympanic Membrane Re-epithelialization Post-tympanoplasty

  3 weeks (21 days following surgery)

• Weekly Evaluation of Tympanic Membrane Re-epithelialization Post-tympanoplasty

  4 weeks (28 days following surgery)

• Weekly Evaluation of Tympanic Membrane Re-epithelialization Post-tympanoplasty

  5 weeks (35 days following surgery)

• Weekly Evaluation of Tympanic Membrane Re-epithelialization Post-tympanoplasty

  6 weeks (42 days following surgery)

• Evaluation of Ototoxicity

  5 weeks (35 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, DKI Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

Otitis Media, Suppurative; Tympanic Membrane Perforation

Condition Hierarchy (Ancestors)

Suppuration; Infections; Otitis Media; Otitis; Ear Diseases; Otorhinolaryngologic Diseases; 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: October 30, 2022
• First Posted: November 4, 2022
• Study Start: June 13, 2021
• Primary Completion: September 29, 2022
• Study Completion: September 29, 2022
• Last Updated: November 4, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)