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Completed

NCT Number: NCT05605262

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

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.

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Key information

Conditions

Otitis Media, Suppurative Ear Diseases Infections Otitis Otitis Media Otorhinolaryngologic Diseases Suppuration Tympanic Membrane Perforation Wounds and Injuries

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Faculty of Medicine - University of Indonesia

Jakarta, DKI Jakarta, 10430, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Manukamed - Manukapli 100% sterile honey wound dressing

Primary outcomes

  1. Weekly Evaluation of Tympanic Membrane Re-epithelialization Post-tympanoplasty

    Time frame: 2 weeks (14 days following surgery)

    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 outcomes

  1. Weekly Evaluation of Tympanic Membrane Re-epithelialization Post-tympanoplasty

    Time frame: 3 weeks (21 days following surgery)

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

    Time frame: 4 weeks (28 days following surgery)

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

    Time frame: 5 weeks (35 days following surgery)

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

    Time frame: 6 weeks (42 days following surgery)

    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. Evaluation of Ototoxicity

    Time frame: 5 weeks (35 days following surgery)

    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.

Sponsors and collaborators

Lead sponsor

Fakultas Kedokteran Universitas Indonesia

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 4, 2022
Registry last updated
Nov 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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