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

Skin Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03929224
• Other study ID #: 1325595
• Status: Completed
• Phase: Phase 4
• Start date: October 25, 2018
• Est. completion date: September 1, 2020

Study information

• Verified date: August 2022
• Source: Ascension South East Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: September 1, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cellulitis
• Skin Diseases, Infectious
• Skin Infection

Intervention

Drug:
• Medicinal honey
Treat healing surgical site with medicinal honey
• Bacitracin
Treat healing surgical site with bacitracin

Locations

Country	Name	City	State
United States	Ascension Providence Hospital, Novi Campus	Novi	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Ascension South East Michigan

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Use of oral antibiotics during the 6 months follow-up was noted.
Secondary	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.	Patients self-reported their pain levels at 1 week, 3 months and 6 months post-op.