A Phase 4 interventional study of Medicinal honey and Bacitracin in Skin Infection, sponsored by Henry Ford Health System. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-07.
Sponsored by Henry Ford Health System · Phase 4, Interventional, and Prevention
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.
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.
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Exclusion Criteria:
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
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
Treat healing surgical site with medicinal honey
Also known as: MEDIHONEY
Treat healing surgical site with bacitracin
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.
Time frame: Photographs of the surgical site were taken at 1 week, 3 months and 6 months post-op.
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.
Time frame: 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.
Time frame: Patients self-reported their pain levels at 1 week, 3 months and 6 months post-op.
| Milestone | Bacitracin | Medicinal Honey |
|---|---|---|
| Started | 8 | 9 |
| Completed | 8 | 9 |
| Not completed | 0 | 0 |
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.
| Grade | Bacitracin | Medicinal Honey |
|---|---|---|
| 1 week | 1.06 ± 0.78 | 0.64 ± 0.57 |
| 3 months | 0.81 ± 0.94 | 0.50 ± 0.56 |
| 6 months | 1.25 ± 1.08 | 0.68 ± 0.70 |
This was determined by whether or not the patient required oral antibiotics during the 6 month follow-up period.
| Participants | Bacitracin | Medicinal Honey |
|---|---|---|
| Number of Participants Requiring Oral Antibiotics | 4 | 0 |
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.
| units on a scale | Bacitracin | Medicinal Honey |
|---|---|---|
| 1 week | 5.00 ± 4.24 | 2.00 ± 2.65 |
| 3 months | 7.33 ± 2.08 | 3.00 ± 2.31 |
| 6 months | 5.83 ± 4.12 | 0.58 ± 1.02 |
Collected over Daily for 14 days post-op and then at the 1 month, 3 month and 6 month time points. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Bacitracin | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Medicinal Honey | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) |
Patients who qualified for BAHI for single-sided deafness, conductive or mixed hearing loss on audiometric testing.
| Age, Categorical(Participants) | Bacitracin | Medicinal Honey | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 8 | 9 | 17 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Bacitracin | Medicinal Honey | Total |
|---|---|---|---|
| Female | 6 | 7 | 13 |
| Male | 2 | 2 | 4 |
| Race (NIH/OMB)(Participants) | Bacitracin | Medicinal Honey | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 2 | 4 |
| White | 6 | 7 | 13 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Bacitracin | Medicinal Honey | Total |
|---|---|---|---|
| United States | 8 | 9 | 17 |
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