Clinical trial NCT03929224: The Use of Medical Grade Honey in the Prevention of Bone Anchored Hearing Aid Associated Skin Breakdown
Official title: The Use of Medical Grade Honey in the Prevention of Bone Anchored Hearing Aid Associated Skin Breakdown
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Skin Infection
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2019-04-26
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Holgers Classification of Skin Reactions at the Surgical Site Graded 0 (no Reaction) to 4 (Worse Outcome)
timeFrame: Photographs of the surgical site were taken at 1 week, 3 months and 6 months post-op.
Secondary outcomes:
measure: Number of Participants Requiring Oral Antibiotics
timeFrame: Use of oral antibiotics during the 6 months follow-up was noted.
measure: 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
timeFrame: Patients self-reported their pain levels at 1 week, 3 months and 6 months post-op.
Other outcomes:
Locations:
city: Novi
country: United States
facility: Ascension Providence Hospital, Novi Campus
state: Michigan
Study officials:
affiliation: Michigan Ear Institute
name: Seilesh Babu, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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. No abstract available.
citation: 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.
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.
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.
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.