The Use of Medical Grade Honey in the Prevention of Bone Anchored Hearing Aid Associated Skin Breakdown
NCT ID: NCT03929224
Last Updated: 2026-01-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
17 participants
INTERVENTIONAL
2018-10-25
2020-09-01
Brief Summary
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Detailed Description
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Treatment groups:
Group 1-patients undergoing BAHI implantation who will be postoperatively treated with medicinal honey.
Group 2- patients undergoing BAHI implantation who will be postoperatively treated with bacitracin ointment as standard care.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Bacitracin
Standard care: Bone-anchored hearing aid (BAHI) abutment incision is coated in bacitracin. A healing cap is placed over the abutment and left for a week. The healing cap is removed on postoperative day 7. Patient is instructed to apply bacitracin ointment to the area for 2 weeks.
Bacitracin
Treat healing surgical site with bacitracin
Medicinal honey
Medicinal honey: Medicinal honey will be applied to the abutment site immediately after surgery. The healing cap will be placed on the BAHI site. The healing cap is removed on postoperative day 7. Patient is instructed to apply medicinal honey daily to the area for 2 weeks.
Medicinal honey
Treat healing surgical site with medicinal honey
Interventions
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Medicinal honey
Treat healing surgical site with medicinal honey
Bacitracin
Treat healing surgical site with bacitracin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
100 Years
ALL
Yes
Sponsors
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Henry Ford Health System
OTHER
Responsible Party
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Principal Investigators
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Seilesh Babu, MD
Role: PRINCIPAL_INVESTIGATOR
Michigan Ear Institute
Locations
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Ascension Providence Hospital, Novi Campus
Novi, Michigan, United States
Countries
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References
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Faucett EA, Reghunathan S, Jacob A. Medicinal honey as treatment for skin reactions associated with bone-anchored hearing implant surgery. Laryngoscope. 2015 Jul;125(7):1720-3. doi: 10.1002/lary.25069. Epub 2014 Dec 4. No abstract available.
Costeloe A, Vandjelovic ND, Evans MA, Saraiya SS. The use of honey in cochlear implant associated wounds in pediatric patients. Int J Pediatr Otorhinolaryngol. 2018 Aug;111:80-83. doi: 10.1016/j.ijporl.2018.05.026. Epub 2018 May 24.
Bento RF, Kiesewetter A, Ikari LS, Brito R. Bone-anchored hearing aid (BAHA): indications, functional results, and comparison with reconstructive surgery of the ear. Int Arch Otorhinolaryngol. 2012 Jul;16(3):400-5. doi: 10.7162/S1809-97772012000300017.
Colquitt JL, Jones J, Harris P, Loveman E, Bird A, Clegg AJ, Baguley DM, Proops DW, Mitchell TE, Sheehan PZ, Welch K. Bone-anchored hearing aids (BAHAs) for people who are bilaterally deaf: a systematic review and economic evaluation. Health Technol Assess. 2011 Jul;15(26):1-200, iii-iv. doi: 10.3310/hta15260.
Fontaine N, Hemar P, Schultz P, Charpiot A, Debry C. BAHA implant: implantation technique and complications. Eur Ann Otorhinolaryngol Head Neck Dis. 2014 Feb;131(1):69-74. doi: 10.1016/j.anorl.2012.10.006. Epub 2013 Jul 5.
Robson V, Dodd S, Thomas S. Standardized antibacterial honey (Medihoney) with standard therapy in wound care: randomized clinical trial. J Adv Nurs. 2009 Mar;65(3):565-75. doi: 10.1111/j.1365-2648.2008.04923.x.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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1325595
Identifier Type: -
Identifier Source: org_study_id
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