The Use of Medical Grade Honey in the Prevention of Bone Anchored Hearing Aid Associated Skin Breakdown

Study Overview
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Brief Summary
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Postoperative medicinal grade honey in post-operative care may prevent bone anchored hearing aid associated skin breakdown better than standard care of bacitracin ointment alone in adult patients.

Detailed Description
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This is a prospective study. Multiple surgeons will perform the bone anchored hearing aids (BAHI) implantation surgery. Patients will be randomized to either postoperative medicinal honey or postoperative standard care of bacitracin ointment alone using a random number generator. There will be a total of two patient groups. The type of BAHI device used, laterally and the surgical technique will be recorded. 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.

Official Title
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The Use of Medical Grade Honey in the Prevention of Bone Anchored Hearing Aid Associated Skin Breakdown

Conditions
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Skin Infection

Intervention / Treatment
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* Drug: Medicinal honey
* Drug: Bacitracin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients undergoing bone-anchored hearing aid implantation surgery. Exclusion Criteria: patients who are undergoing revision bone-anchored hearing surgery, history of radiation to the implantation site.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bacitracin<br>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. | Drug: Bacitracin<br>* Treat healing surgical site with bacitracin<br>|
| Experimental: Medicinal honey<br>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. | Drug: Medicinal honey<br>* Treat healing surgical site with medicinal honey<br>* Other names: MEDIHONEY;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Holgers Classification of Skin Reactions at the Surgical Site Graded 0 (no Reaction) to 4 (Worse Outcome) | Postoperative wound healing was compared between two groups of patients, one group had medicinal honey applied at the BAHI abutment surgical site for the first 2 weeks postoperatively, while the other group had bacitracin applied for 2 weeks. The skin at the surgical site was photographed at each time point and the photographs randomized for evaluation. The appearance of the surgical site skin was graded based on Holgers Classification by 5 separate, blinded Otolaryngologists. Holgers Classification is graded Grade 0 to Grade 4 with Grade 4 having a worse outcome. Any skin breakdown will be graded based on the Holgers Classification: Grade 0 = no reaction; Grade 1 = reddish discoloration of the skin around the implant; Grade 2 = red and moist surface of the skin around the implant; Grade 3 = formation of granulation tissue around the implant; and Grade 4 = extensive soft-tissue reaction. Holgers score was not recorded before or the day of surgery. | Photographs of the surgical site were taken at 1 week, 3 months and 6 months post-op. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Requiring Oral Antibiotics | This was determined by whether or not the patient required oral antibiotics during the 6 month follow-up period. | Use of oral antibiotics during the 6 months follow-up was noted. | 
| Assessment of Pain at the Abutment Site Using the 0-10 Pain Scale With 0 Being no Pain At All and 10 Being the Worst Possible Pain | Patient's self-reported level of pain at the abutment site was provided based on the 0 to 10 Pain Scale with 0 being no pain at all, and 10 being the worst possible pain. Pain prior to surgery is not routinely assessed. | Patients self-reported their pain levels at 1 week, 3 months and 6 months post-op. |