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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Manukamed - 100% sterile manuka honey |
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| Control | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Manukamed - Manukapli 100% sterile honey wound dressing - Premium medical grade 16+ Leptospermum Scoparium New Zealand honey | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 2 weeks (14 days following surgery) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Harim Priyono | Faculty of Medicine, University of Indonesia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine - University of Indonesia | Jakarta | DKI Jakarta | 10430 | Indonesia |
If requested, data records without identifying patient information can be shared
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 20, 2022 |
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| 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). | 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). | 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). | 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. | 5 weeks (35 days following surgery) |
| Oct 28, 2022 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D010035 | Otitis Media, Suppurative |
| D018058 | Tympanic Membrane Perforation |
| ID | Term |
|---|---|
| D013492 | Suppuration |
| D007239 | Infections |
| D010033 | Otitis Media |
| D010031 | Otitis |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D014947 | Wounds and Injuries |
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