NCT03929224

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Henry Ford Health System · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
DRUG	Medicinal honey	Treat healing surgical site with medicinal honey
DRUG	Bacitracin	Treat healing surgical site with bacitracin

Timeline

• Start date: 2018-10-25
• Primary completion: 2020-09-01
• Completion: 2020-09-01
• First posted: 2019-04-26
• Last updated: 2026-01-07
• Results posted: 2022-08-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study