A Phase 2/3 interventional study of Manukamed - Manukapli 100% sterile honey wound dressing - Premium medical grade 16+ Leptospermum Scoparium New Zealand honey in Otitis Media, Suppurative and Tympanic Membrane Perforation, sponsored by Fakultas Kedokteran Universitas Indonesia. Completed at 1 site in Indonesia. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2022-11-04.
Sponsored by Fakultas Kedokteran Universitas Indonesia · Phase 2/3, Interventional, and Supportive care
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.
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.
53 studies on the registry are indexed under Tympanic Membrane Perforation; 14 are open to participants now.
This study's enrollment of 64 is above the median of 57 across 39 interventional studies indexed under Tympanic Membrane Perforation.
Browse Tympanic Membrane Perforation studies →Fakultas Kedokteran Universitas Indonesia is the lead sponsor of 36 studies on the registry; 6 are open to participants now.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Manukamed - 100% sterile manuka honey
Drug: Manukamed - Manukapli 100% sterile honey wound dressing - Premium medical grade 16+ Leptospermum Scoparium New Zealand honey
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.
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.
Also known as: Manukamed - Manukapli 100% sterile honey wound dressing
Weekly Evaluation of Tympanic Membrane Re-epithelialization Post-tympanoplasty
Epithelialization of the tympanic membrane was measured using an indicator tool utilizing a filter paper (5 mm in width and 10 mm in length) with a water-based ink on one end as the indicator. Exposure of the indicator to the exudate on the surface of the tympanic membrane will reveal the status of the wound (wet/ dry).
Time frame: 2 weeks (14 days following surgery)
Weekly Evaluation of Tympanic Membrane Re-epithelialization Post-tympanoplasty
Epithelialization of the tympanic membrane was measured using an indicator tool utilizing a filter paper (5 mm in width and 10 mm in length) with a water-based ink on one end as the indicator. Exposure of the indicator to the exudate on the surface of the tympanic membrane will reveal the status of the wound (wet/ dry).
Time frame: 3 weeks (21 days following surgery)
Weekly Evaluation of Tympanic Membrane Re-epithelialization Post-tympanoplasty
Epithelialization of the tympanic membrane was measured using an indicator tool utilizing a filter paper (5 mm in width and 10 mm in length) with a water-based ink on one end as the indicator. Exposure of the indicator to the exudate on the surface of the tympanic membrane will reveal the status of the wound (wet/ dry).
Time frame: 4 weeks (28 days following surgery)
Weekly Evaluation of Tympanic Membrane Re-epithelialization Post-tympanoplasty
Epithelialization of the tympanic membrane was measured using an indicator tool utilizing a filter paper (5 mm in width and 10 mm in length) with a water-based ink on one end as the indicator. Exposure of the indicator to the exudate on the surface of the tympanic membrane will reveal the status of the wound (wet/ dry).
Time frame: 5 weeks (35 days following surgery)
Weekly Evaluation of Tympanic Membrane Re-epithelialization Post-tympanoplasty
Epithelialization of the tympanic membrane was measured using an indicator tool utilizing a filter paper (5 mm in width and 10 mm in length) with a water-based ink on one end as the indicator. Exposure of the indicator to the exudate on the surface of the tympanic membrane will reveal the status of the wound (wet/ dry).
Time frame: 6 weeks (42 days following surgery)
Evaluation of Ototoxicity
Hearing function will be evaluated by conducting a Brain Evoked Response Audiometry exam. If the BERA results show decreased stimulus of more than 10 decibels, treatment for sudden deafness is started immediately.
Time frame: 5 weeks (35 days following surgery)
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — If requested, data records without identifying patient information can be shared
Ran from Jun 2021 to primary completion in Sep 2022, 15 months.
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Tympanic Membrane Perforation →
Fakultas Kedokteran Universitas Indonesia