Clinical trial NCT05657717: Safety Profile of Applied 100% Manuka Honey in Tympanoplasty
Official title: Otological Safety Profile of 100% Manuka Honey Application in Tympanoplasty: A Double-blinded Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Chronic Suppurative Otitis Media
Tympanic Membrane; Wound
Keywords: Chronic Suppurative Otitis Media
Manuka Honey
Tympanic Membrane
Otologic Safety
Lead sponsor: Fakultas Kedokteran Universitas Indonesia
Sponsor class: OTHER
First posted: 2022-12-20
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 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.

Detailed description: The aim of the present study is to conduct a randomized clinical trial to evaluate the otological safety of 100% medical grade Manuka honey on 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 otological safety of 100% sterile Manuka honey on 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: Evaluation of Ototoxicity - BERA
timeFrame: Time Frame: 5 weeks (35 days following surgery)
measure: Evaluation of Ototoxicity - Audiometry
timeFrame: Time Frame: 6 weeks (42 days following surgery)
Secondary outcomes:
measure: Evaluation of Ototoxicity - Symptoms - Tinnitus
timeFrame: Time Frame: 6 weeks (42 days following surgery)
measure: Evaluation of Ototoxicity - Symptoms - Hearing Loss
timeFrame: Time Frame: 6 weeks (42 days following surgery)
measure: Evaluation of Ototoxicity - Symptoms - Dysequilibrium
timeFrame: Time Frame: 6 weeks (42 days following surgery)
Other outcomes:
Locations:
city: Jakarta Pusat
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: