Skin InfectionPhase 4NCT03929224
The Use of Medical Grade Honey in the Prevention of Bone Anchored Hearing Aid Associated Skin Breakdown
A Phase 4 study testing Medicinal honey and Bacitracin in people with Skin Infection, run by Henry Ford Health System at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Infection
- What is being tested?
- Medicinal honey and Bacitracin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2018to 1 Sep 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients undergoing bone-anchored hearing aid implantation surgery.
Who cannot join
- patients who are undergoing revision bone-anchored hearing surgery, history of radiation to the implantation site.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ascension Providence Hospital, Novi Campus
Novi, Michigan, 48374
About this study
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.
Read the detailed description
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.
- Conditions
- Skin Infection
- Being tested
- Medicinal honey, Bacitracin
- Medical subject headings
- Cellulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medicinal honeyDrug
Also called MEDIHONEY
Treat healing surgical site with medicinal honey
BacitracinDrug
Treat healing surgical site with bacitracin
| Study group | Role | What they receive |
|---|---|---|
| Bacitracin | Active comparator | 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. Receives: Drug: Bacitracin |
| Medicinal honey | Experimental | 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. Receives: Drug: Medicinal honey |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Photographs of the surgical site were taken at 1 week, 3 months and 6 months post-op.
Secondary outcomes (2)
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.
Measured: 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.
Measured: Patients self-reported their pain levels at 1 week, 3 months and 6 months post-op.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2019
- Study start25 Oct 2018
- Primary completion1 Sep 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Skin InfectionStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Seilesh Babu, MD, Principal investigator, Michigan Ear Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03929224
- Sponsor's protocol ID
- 1325595
- Status last verified
- Aug 2022
- First submitted
- 18 Mar 2019
- Last updated
- 7 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 29958620Faucett 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.
PubMed 25476170Bento 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.
PubMed 25991965Colquitt 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.
PubMed 21729632Fontaine 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.
PubMed 23835074Robson 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.
PubMed 19222654
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Medical Grade Honey in the Prevention of Bone Anchored Hearing Aid Associated Skin Breakdown
- ClinicalTrials.gov ID
- NCT03929224
- Acronym / sponsor ID
- 1325595
- Conditions
- Skin Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 25 Oct 2018 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 26 Apr 2019 (actual)
- Results
- Posted 30 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bacitracin | Active comparator | Drug: BacitracinStandard 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. |
| Medicinal honey | Experimental | Drug: Medicinal honeyMedicinal 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing bone-anchored hearing aid implantation surgery.
Key exclusion criteria (1 listed)
- patients who are undergoing revision bone-anchored hearing surgery, history of radiation to the implantation site.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medicinal honeyAlso: MEDIHONEYTreat healing surgical site with medicinal honey | Drug | Medicinal honey |
| BacitracinTreat healing surgical site with bacitracin | Drug | Bacitracin |
Primary outcome
Holgers Classification of Skin Reactions at the Surgical Site Graded 0 (no Reaction) to 4 (Worse Outcome)
Time frame: Photographs of the surgical site were taken at 1 week, 3 months and 6 months post-op.
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.
2 secondary outcomes
Number of Participants Requiring Oral Antibiotics
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
Time frame: Patients self-reported their pain levels at 1 week, 3 months and 6 months post-op.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29958620Costeloe 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.
- Background: PubMed 25476170Faucett 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.
- Background: PubMed 25991965Bento 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.
- Background: PubMed 21729632Colquitt 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.
- Background: PubMed 23835074Fontaine 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.
- Background: PubMed 19222654Robson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seilesh Babu, MD principal investigator
Michigan Ear Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Medicinal honey and Bacitracin in people with Skin Infection, run by Henry Ford Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Holgers Classification of Skin Reactions at the Surgical Site Graded 0 (no Reaction) to 4 (Worse Outcome) (time frame: Photographs of the surgical site were taken at 1 week, 3 months and 6 months post-op.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03929224, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.