Safety Profile of Applied 100% Manuka Honey in Tympanoplasty

University of Indonesia (UI)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Chronic Suppurative Otitis Media; Tympanic Membrane; Wound

Treatments: Drug: Manukamed - Manukapli 100% sterile honey wound dressing - Premium medical grade 16+ Leptospermum Scoparium New Zealand honey

Study type: Interventional

Funder types: Other

Identifiers

NCT05657717

21040426

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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64 participants in 2 patient groups

Intervention

Experimental group

Description:

Manukamed - 100% sterile manuka honey

Treatment:

Drug: Manukamed - Manukapli 100% sterile honey wound dressing - Premium medical grade 16+ Leptospermum Scoparium New Zealand honey

Control

No Intervention group

Description:

No intervention was given. Participants receive standard wound care of the tympanic membrane which includes 0.3% Ofloxacin otic ear drops which were used twice a day for 5 days.