Trial Outcomes & Findings for The Use of Medical Grade Honey in the Prevention of Bone Anchored Hearing Aid Associated Skin Breakdown (NCT NCT03929224)

Last Updated: 2026-01-07

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

17 participants

Primary outcome timeframe

Photographs of the surgical site were taken at 1 week, 3 months and 6 months post-op.

Results posted on

2026-01-07

Participant Flow

Participant milestones

Participant milestones
Measure	Bacitracin Standard care: 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 in addition to the bacitracin. 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 and bacitracin: Treat healing surgical site with medicinal honey and bacitracin
Overall Study STARTED	8	9
Overall Study COMPLETED	8	9
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bacitracin n=8 Participants Standard care: 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 n=9 Participants 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	Total n=17 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=37 Participants	0 Participants n=56 Participants	0 Participants n=95 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=37 Participants	9 Participants n=56 Participants	17 Participants n=95 Participants
Age, Categorical >=65 years	0 Participants n=37 Participants	0 Participants n=56 Participants	0 Participants n=95 Participants
Sex: Female, Male Female	6 Participants n=37 Participants	7 Participants n=56 Participants	13 Participants n=95 Participants
Sex: Female, Male Male	2 Participants n=37 Participants	2 Participants n=56 Participants	4 Participants n=95 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=37 Participants	0 Participants n=56 Participants	0 Participants n=95 Participants
Race (NIH/OMB) Asian	0 Participants n=37 Participants	0 Participants n=56 Participants	0 Participants n=95 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=37 Participants	0 Participants n=56 Participants	0 Participants n=95 Participants
Race (NIH/OMB) Black or African American	2 Participants n=37 Participants	2 Participants n=56 Participants	4 Participants n=95 Participants
Race (NIH/OMB) White	6 Participants n=37 Participants	7 Participants n=56 Participants	13 Participants n=95 Participants
Race (NIH/OMB) More than one race	0 Participants n=37 Participants	0 Participants n=56 Participants	0 Participants n=95 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=37 Participants	0 Participants n=56 Participants	0 Participants n=95 Participants
Region of Enrollment United States	8 participants n=37 Participants	9 participants n=56 Participants	17 participants n=95 Participants

PRIMARY outcome

Timeframe: Photographs of the surgical site were taken at 1 week, 3 months and 6 months post-op.

Population: Patients qualified for BAHI: single-sided deafness, conductive or mixed hearing loss on audiometric testing.

Outcome measures

Outcome measures
Measure	Bacitracin n=8 Participants Standard care: 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 n=9 Participants 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
Holgers Classification of Skin Reactions at the Surgical Site Graded 0 (no Reaction) to 4 (Worse Outcome) 1 week	1.06 Grade Standard Deviation 0.78	0.64 Grade Standard Deviation 0.57
Holgers Classification of Skin Reactions at the Surgical Site Graded 0 (no Reaction) to 4 (Worse Outcome) 3 months	0.81 Grade Standard Deviation 0.94	0.50 Grade Standard Deviation 0.56
Holgers Classification of Skin Reactions at the Surgical Site Graded 0 (no Reaction) to 4 (Worse Outcome) 6 months	1.25 Grade Standard Deviation 1.08	0.68 Grade Standard Deviation 0.70

SECONDARY outcome

Timeframe: Use of oral antibiotics during the 6 months follow-up was noted.

This was determined by whether or not the patient required oral antibiotics during the 6 month follow-up period.

Outcome measures

Outcome measures
Measure	Bacitracin n=8 Participants Standard care: 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 n=9 Participants 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
Number of Participants Requiring Oral Antibiotics	4 Participants	0 Participants

SECONDARY outcome

Timeframe: Patients self-reported their pain levels at 1 week, 3 months and 6 months post-op.

Population: The number of participants providing self-reported pain levels varied across time points.

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.

Outcome measures

Outcome measures
Measure	Bacitracin n=8 Participants Standard care: 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 n=9 Participants 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
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 1 week	5.00 units on a scale Standard Deviation 4.24	2.00 units on a scale Standard Deviation 2.65
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 3 months	7.33 units on a scale Standard Deviation 2.08	3.00 units on a scale Standard Deviation 2.31
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 6 months	5.83 units on a scale Standard Deviation 4.12	0.58 units on a scale Standard Deviation 1.02

Adverse Events

Bacitracin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Medicinal Honey

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Seilish Babu, MD

Michigan Ear Institute

Phone: (248) 865-4444

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place