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

Tympanic Membrane Perforation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05605262
• Other study ID #: 21040425
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: June 13, 2021
• Est. completion date: September 29, 2022

Study information

• Verified date: October 2022
• Source: Fakultas Kedokteran Universitas Indonesia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: September 29, 2022
• Est. primary completion date: September 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Otitis
• Otitis Media
• Otitis Media, Suppurative
• Tympanic Membrane Perforation

Intervention

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.

Locations

Country	Name	City	State
Indonesia	Faculty of Medicine - University of Indonesia	Jakarta	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Fakultas Kedokteran Universitas Indonesia

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)