Clinical trial NCT05605262: Effects of 100% Medical Grade Manuka Honey on Tympanic Membrane Reconstruction Healing.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Otitis Media, Suppurative
Tympanic Membrane Perforation
Keywords: Chronic Suppurative Otitis Media
Manuka Honey
Wound Healing
Re-epithelialization
Tympanoplasty
Tympanic Membrane
Lead sponsor: Fakultas Kedokteran Universitas Indonesia
Sponsor class: OTHER
First posted: 2022-11-04
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Weekly Evaluation of Tympanic Membrane Re-epithelialization Post-tympanoplasty
timeFrame: 2 weeks (14 days following surgery)
Secondary outcomes:
measure: Weekly Evaluation of Tympanic Membrane Re-epithelialization Post-tympanoplasty
timeFrame: 3 weeks (21 days following surgery)
measure: Weekly Evaluation of Tympanic Membrane Re-epithelialization Post-tympanoplasty
timeFrame: 4 weeks (28 days following surgery)
measure: Weekly Evaluation of Tympanic Membrane Re-epithelialization Post-tympanoplasty
timeFrame: 5 weeks (35 days following surgery)
measure: Weekly Evaluation of Tympanic Membrane Re-epithelialization Post-tympanoplasty
timeFrame: 6 weeks (42 days following surgery)
measure: Evaluation of Ototoxicity
timeFrame: 5 weeks (35 days following surgery)
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Faculty of Medicine - University of Indonesia
state: DKI Jakarta
Study officials:
affiliation: Faculty of Medicine, University of Indonesia
name: Harim Priyono
role: PRINCIPAL_INVESTIGATOR
References: