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

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ClinicalTrials.gov Identifier: NCT03929224
Recruitment Status : Recruiting
First Posted : April 26, 2019
Last Update Posted : April 26, 2019
Sponsor:
Information provided by (Responsible Party):
Ascension South East Michigan

Brief Summary:
Postoperative medicinal grade honey in addition to standard post-operative care may prevent bone anchored hearing aid associated skin breakdown better than standard care alone in adult patients

Condition or disease Intervention/treatment Phase
Skin Infection Drug: Medicinal honey and bacitracin Drug: Bacitracin Phase 4

Detailed Description:

This is a prospective study. Multiple surgeons will perform the bone anchored hearing aids (BAHA) implantation surgery. Patients will be randomized to either postoperative medicinal honey and standard care or postoperative standard care alone using a random number generator. There will be a total of two patient groups. The type of BAHA device used, laterally and the surgical technique will be recorded.

Treatment groups:

Group 1-patients undergoing BAHA implantation who will be postoperatively treated with medicinal honey and standard care.

Group 2- patients undergoing BAHA implantation who will be postoperatively treated with standard care.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Use of Medical Grade Honey in the Prevention of Bone Anchored Hearing Aid Associated Skin Breakdown
Actual Study Start Date : October 25, 2018
Estimated Primary Completion Date : October 2, 2019
Estimated Study Completion Date : October 2, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hearing Aids

Arm Intervention/treatment
Active Comparator: Bacitracin
Standard care: BAHA 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
Treat healing surgical site with bacitracin

Experimental: Medicinal honey and bacitracin
Standard care + MediHoney: Medi-Honey will be applied to the abutment site immediately after surgery in addition to the bacitracin. The healing cap will be placed on the BAHA site. The healing cap is removed on postoperative day 7. Patient is instructed to apply bacitracin ointment and MediHoney daily to the area for 2 weeks.
Drug: Medicinal honey and bacitracin
Treat healing surgical site with medicinal honey and bacitracin
Other Name: MediHoney




Primary Outcome Measures :
  1. Assessment of MediHoney application on the surgical site [ Time Frame: The surgical site will be graded 1-week post-op. ]
    The surgical site will be graded based on the Holger Classification.

  2. Assessment of MediHoney application on the surgical site [ Time Frame: The surgical site will be graded 1-month post-op. ]
    The surgical site will be graded based on the Holger Classification.

  3. Assessment of MediHoney application on the surgical site [ Time Frame: The surgical site will be graded 3-months post-op. ]
    The surgical site will be graded based on the Holger Classification.

  4. Assessment of MediHoney application on the surgical site [ Time Frame: The surgical site will be graded 6-months post-op. ]
    The surgical site will be graded based on the Holger Classification.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03929224


Contacts
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Contact: Seilesh Babu, MD (248) 865-4444 sbabu@gmail.com
Contact: Marianne Lahey, BSN (248) 465-4828 Marianne.Lahey@ascension.org

Locations
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United States, Michigan
Ascension Providence Hospital, Novi Campus Recruiting
Novi, Michigan, United States, 48374
Contact: Seilish Babu, MD    248-865-4444    sbabu@gmail.com   
Contact: Seilish Babu, MD    (248) 865-4444    sbabu@gmail.com   
Sponsors and Collaborators
Ascension South East Michigan
Investigators
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Principal Investigator: Seilesh Babu, MD Michigan Ear Institute

Publications:
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Responsible Party: Ascension South East Michigan
ClinicalTrials.gov Identifier: NCT03929224     History of Changes
Other Study ID Numbers: 1325595
First Posted: April 26, 2019    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Cellulitis
Skin Diseases, Infectious
Infection
Suppuration
Connective Tissue Diseases
Inflammation
Pathologic Processes
Skin Diseases
Bacitracin
Anti-Infective Agents, Local
Anti-Infective Agents
Anti-Bacterial Agents