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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
64
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.
Faculty of Medicine - University of Indonesia
Jakarta Pusat, DKI Jakarta, Indonesia
Evaluation of Ototoxicity - BERA
Hearing function will be evaluated by conducting a Brain Evoked Response Audiometry (BERA) exam. If the BERA results show decreased stimulus of more than 10 decibels compared to baseline, treatment is started immediately.
Time frame: Time Frame: 5 weeks (35 days following surgery)
Evaluation of Ototoxicity - Audiometry
Hearing function will be evaluated by conducting a Pure Tone Audiometry exam. Results are compared to baseline and evaluated. If there is a 20db or greater decrease in pure-tone threshold at one frequency or 10db or greater decreased at 2 adjacent frequencies, treatment is started immediately.
Time frame: Time Frame: 6 weeks (42 days following surgery)
Evaluation of Ototoxicity - Symptoms - Tinnitus
Participants will be asked to complete a questionnaire regarding tinnitus. Subjective symptoms are measured using a visual analog scale ranging from 1-10, with higher scores indicating worse symptoms.
Time frame: Time Frame: 6 weeks (42 days following surgery)
Evaluation of Ototoxicity - Symptoms - Hearing Loss
Participants will be asked to complete a questionnaire regarding hearing loss. Subjective symptoms are measured using a visual analog scale ranging from 1-10, with higher scores indicating worse symptoms.
Time frame: Time Frame: 6 weeks (42 days following surgery)
Evaluation of Ototoxicity - Symptoms - Dysequilibrium
Participants will be asked to complete a questionnaire regarding dysequilibrium. Subjective symptoms are measured using a visual analog scale ranging from 1-10, with higher scores indicating worse symptoms.
Time frame: Time Frame: 6 weeks (42 days following surgery)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.