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

NCT03929224 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 1325595
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Skin Infection

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  Patients self-reported their pain levels at 1 week, 3 months and 6 months post-op.

Study Arms (2)

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.

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.

Drug: Medicinal honey

Interventions

Medicinal honey DRUG

Treat healing surgical site with medicinal honey

Also known as: MEDIHONEY

Medicinal honey

Bacitracin DRUG

Treat healing surgical site with bacitracin

Bacitracin

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients undergoing bone-anchored hearing aid implantation surgery.

You may not qualify if:

• patients who are undergoing revision bone-anchored hearing surgery, history of radiation to the implantation site.

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Ascension Providence Hospital, Novi Campus

Novi, Michigan, 48374, United States

Location

Related Publications (6)

• 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.

  PMID: 29958620 BACKGROUND

• Faucett 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.

  PMID: 25476170 BACKGROUND

• Bento 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.

  PMID: 25991965 BACKGROUND

• Colquitt 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.

  PMID: 21729632 BACKGROUND

• Fontaine 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.

  PMID: 23835074 BACKGROUND

• Robson 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.

  PMID: 19222654 BACKGROUND

MeSH Terms

Conditions

Cellulitis

Interventions

Bacitracin

Condition Hierarchy (Ancestors)

Skin Diseases, Infectious; Infections; Suppuration; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

The sample size was small.

Results Point of Contact

• Title: Seilish Babu, MD
• Organization: Michigan Ear Institute

sbabu04@gmail.com

(248) 865-4444

Study Officials

• Seilesh Babu, MD

  Michigan Ear Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2019
• First Posted: April 26, 2019
• Study Start: October 25, 2018
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: January 7, 2026
• Results First Posted: August 30, 2022

Record last verified: 2022-08

Locations

US (1)