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

Henry Ford Health System17 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Skin Infection

Interventions

Medicinal honeyDRUG

Treat healing surgical site with medicinal honey

BacitracinDRUG

Treat healing surgical site with bacitracin

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Ascension Providence Hospital, Novi Campus

Novi, Michigan, United States

Outcomes

Primary Outcomes

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.

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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