Otological Safety Profile of 100% Manuka Honey Application in Tympanoplasty: A Double-blinded Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Evaluation of Ototoxicity - BERA
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Intervention
Manukamed - 100% sterile manuka honey
干预措施: Manukamed - Manukapli 100% sterile honey wound dressing - Premium medical grade 16+ Leptospermum Scoparium New Zealand honey (Drug)
结局指标
主要结局
Evaluation of Ototoxicity - BERA
时间窗: Time Frame: 5 weeks (35 days following surgery)
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.
Evaluation of Ototoxicity - Audiometry
时间窗: Time Frame: 6 weeks (42 days following surgery)
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.
次要结局
- Evaluation of Ototoxicity - Symptoms - Tinnitus(Time Frame: 6 weeks (42 days following surgery))
- Evaluation of Ototoxicity - Symptoms - Hearing Loss(Time Frame: 6 weeks (42 days following surgery))
- Evaluation of Ototoxicity - Symptoms - Dysequilibrium(Time Frame: 6 weeks (42 days following surgery))