The Use of Medical Grade Honey in the Prevention of Bone Anchored Hearing Aid Associated Skin Breakdown
Phase: PHASE4
Conditions: Skin Infection
Sponsor: Henry Ford Health System

The Use of Medical Grade Honey in the Prevention of Bone Anchored Hearing Aid Associated 
Skin Breakdown 
 
NTC03929224 
February 4, 2022 
 
 

The Use of Medical Grade Honey in the Prevention of 
Bone Anchored Hearing Aid Associated Skin Breakdown 
 
Anya Costeloe, MD;  Robert Conway, MD; Seilesh Babu, MD 
Michigan Ear Institute 
 
 
Background 
 
Medical grade honey has recently became much more widely used and research continues to 
prove its strong antimicrobial effects. Medical grade honey is currently used across medicine 
for burns, wound infections, skin ulcers and more. In otolaryngology, it has been used for post-
tonsillectomy pain, radiation induced mucositis, necrotizing fasciitis, and allergic fungal sinusitis 
(1). One study previously looked at the use of Medihoney to treat BAHA associated skin 
infections and saw a decrease in healing time from 5.25 weeks with just antibiotics, to less than 
2 weeks with the addition of Medihoney (2). 
 
Bone anchored hearing aids (BAHAs) implantation is a common otologic operation done today. 
BAHAs are generally reserved for those who fail conventional air conduction hearing aids, 
typically secondary to external or middle ear pathology such as aural atresia or a chronically 
draining ear (3). BAHAs can be done in a single step or two-part operation. A titanium screw is 
placed into the mastoid bone for osteointegration. An abutment is then attached to the screw 
which protrudes through the skin. A sound processor then attaches to this abutment to allow 
bone conduction to the cochlea. Complications due to this procedure are relatively few; due to 
the abutment that comes through the skin, soft tissue infections are the most common, 
followed by failure of integration (4).  
 
The Holger scale is typically used when classifying skin complications post operatively. It 
involves a scale from 0-4, 0 being no involvement, 4 being involvement that necessitates BAHA 
removal. Depending on the severity of the disease, treatment can include anything from topical 
antibiotics, topical steroids and wound care for mild cases, to oral antibiotics and steroid 
injections for moderate cases, to simple skin excision or skin flaps for the more severe 
involvement (5).  
 
A typical post-operative course after BAHA surgery at our institution includes bacitracin 
ointment with a bandage that stays on for seven days. After the seventh postoperative day, the 
bandage is removed and bacitracin is applied two times per day for the next two weeks.  
 

Since medical honey has been shown useful for treatment of skin complications after BAHA, we 
propose using medical honey in the postoperative period, which we believe will decrease the 
number of skin infections and lower the average Holger score. 
 
Objective/Research Question  
Does postoperative use of medicinal grade prevent bone anchored hearing aid (BAHA) 
associated skin breakdown better than standard care alone in adult patients? 
 
Hypothesis 
Postoperative use of medicinal honey will decrease the rate of BAHA associated complications 
caused by skin breakdown and reactions in adult patients. 
 
Methodology 
This will be a prospective study. Multiple surgeons will perform the BAHA implantation surgery 
and their combined patients will be used in this study. Patients presenting in clinic for BAHA 
implantation surgery will be explained the details of the study, asked to participate and if 
agreeable asked to sign an informed consent document. The surgeon who will be performing 
the surgery or the resident working with that surgeon will recruit participants. Patient 
demographic information, including age, sex, and reason for implantation will be collected and 
recorded in a table. 
 
The patients will be randomized to either postoperative medicinal honey and standard care or 
postoperative standard care alone using a random number generator. There will be a total of 
two patient groups. The type of BAHA device used, laterality and the surgical technique will be 
recorded in a table. The different types of implanted hearing devices will include BAHA 
Connect, BAHA Attract and Sophono brand hearing devices.  
 
a. Treatment groups 
i. 
Group 1 - patients undergoing BAHA implantation who will be postoperatively 
treated with medicinal honey. 
ii. 
Group 2 - patients undergoing BAHA implantation who will be postoperatively 
treated with standard care. 
 
b. Postoperative care 
i. 
Standard care: BAHA abutment incision is coated in bacitracin. A healing cap is 
placed over the abutment and left on 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.  

ii. 
MediHoney: BAHA abutment incision is coated with MediHoney.  The healing 
cap will be placed over the BAHA site. The healing cap is removed on 
postoperative day 7. Patient is instructed to apply MediHoney daily to the area 
for 2 weeks.  
 
Patients will be seen in clinic 1-week post-op, 1-month post-op, 3 months post-op and 6 
months post-op. During each visit the BAHA site will examined. Pictures will be taken of the  
site and blindly reviewed by appropriate clinicians. 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 that requires implant removal or leads to implant loss. 
 
The study will be included on clinicaltrials.gov.  
                                                                                              
Inclusion Criteria 
Adults >18 years old undergoing bone-anchored hearing aid implantation surgery. 
 
Exclusion Criteria 
Patients who are undergoing revision BAHA surgery, history of radiation to the implantation 
site. 
                                                                            
 
Data Analysis 
The main study hypothesis will be evaluated using one-way ANOVA to compare the rates of skin 
breakdown in the group treated with medicinal honey  versus the group treated only with 
standard care for both the adult patients. 
 
Additionally, between-group differences in demographics and relevant clinical characteristics 
will be probed using ANOVA and chi-square analyses. If significant group differences in these 
factors are detected, follow-up ANOVA analyses will be conducted to control for covariates that 
may influence group differences in weight gain. 
 
Power analysis 
To achieve statistical significance of power and alpha of 0.05 for a 2 group ANOVA, we will 
calculate the minimum total sample required to detect difference. 
 

Typical postoperative BAHA skin reactions occur at a rate between 5-20%. One study looking at 
medihoney in secondary intention wound healing saw a 12.2% increase in wound healing in the 
medihoney group at 12 weeks. 
 
Using 16% for a incidence rate in the control group and 3.8% as a possible incidence in the 
experimental group; at a 5% significance level and a power of .8 a sample size of 186 would be 
required. 
 
Data Safety Monitoring Plan 
Patients' medical record numbers will be recorded on the data collection sheet for purpose of 
accurate retrieval of records. For the analysis of the data the Excel file will have a log number 
assigned to each patient. This log number will be used to identify subjects in the database to be 
created. Chart reviews will be conducted only by the principal authors and those directly 
involved with the research project. No patient-identifiable protected health system information 
will be removed from the hospital. Conscious effort will always be made to keep all patient-
related information logs and sheets in a secure place free from public display and access. All 
electronic data will be stored on a password-protected computer drive. If data are emailed, 
email encryption will be used.  
 
References 
 
1. Costeloe, A., Vandjelovic, N. D., Evans, M. A., & Saraiya, S. S. (2018). The use of honey in 
cochlear implant associated wounds in pediatric patients. International Journal of 
Pediatric Otorhinolaryngology, 111, 80–83. https://doi.org/10.1016/j.ijporl.2018.05.026 
2. Faucett, E. A., Reghunathan, S., & Jacob, A. (2015). Medicinal honey as treatment for 
skin reactions associated with bone-anchored hearing implant surgery: Medicinal Honey 
for BAHI Skin Reactions. The Laryngoscope, 125(7), 1720–1723. 
https://doi.org/10.1002/lary.25069 
3. Bento, R., Kiesewetter, A., Ikari, L., & Brito, R. (2013). Bone-anchored hearing aid 
(BAHA): indications, functional results, and comparison with reconstructive surgery of 
the ear. International Archives of Otorhinolaryngology, 16(3), 400–405. 
https://doi.org/10.7162/S1809-97772012000300017 
4. Colquitt, J., Jones, J., Harris, P., Loveman, E., Bird, A., Clegg, A., … Welch, K. (2011). Bone-
anchored hearing aids (BAHAs) for people who are bilaterally deaf: a systematic review 
and economic evaluation. Health Technology Assessment, 15(26). 
https://doi.org/10.3310/hta15260 

5. Fontaine, N., Hemar, P., Schultz, P., Charpiot, A., & Debry, C. (2014). BAHA implant: 
Implantation technique and complications. European Annals of Otorhinolaryngology, 
Head and Neck Diseases, 131(1), 69–74. https://doi.org/10.1016/j.anorl.2012.10.006 
6. Robson, V., Dodd, S., & Thomas, S. (2009). Standardized antibacterial honey 
(MedihoneyTM) with standard therapy in wound care: randomized clinical trial. Journal of 
Advanced Nursing, 65(3), 565–575. https://doi.org/10.1111/j.1365-2648.2008.04923.x 
 
 
 
Data Collection Tables 
I. 
Patient Demographics: age, gender, race, comorbidities, type of hearing loss (HL), 
hearing loss etiologies 
II. 
Type of Hearing Aid, Laterality and Surgical Technique 
III. 
Post-Operative Complications 
 
 
Table I. Patient Demographics 
 
Age 
Gender 
Race 
Type of HL 
HL Etiology 
Level of HL 
Patient ID 
 
 
 
 
 
 
Table II. Type of Hearing Aid, Laterality and Surgical Technique 
 
 
Hearing Aid 
Laterality 
Surgical Technique 
Patient ID 
 
 
 
 
 
Table III. Post-Operative Complications 
 
 
1 week 
1 month 
3 months 
6 months 
Patient ID