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

Henry Ford Health

Status and phase: Completed; Phase 4

Conditions: Skin Infection

Treatments: Drug: Medicinal honey; Drug: Bacitracin

Study type: Interventional

Funder types: Other

Identifiers

NCT03929224

1325595

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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17 participants in 2 patient groups

Bacitracin

Active Comparator group

Description:

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.

Treatment:

Drug: Bacitracin

Medicinal honey

Experimental group

Description:

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.

Treatment:

Drug: Medicinal honey