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Propionibacterium Acnes in Shoulder Arthroplasty

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ClinicalTrials.gov Identifier: NCT03057821
Recruitment Status : Enrolling by invitation
First Posted : February 20, 2017
Last Update Posted : August 22, 2018
Sponsor:
Information provided by (Responsible Party):
Peter Chalmers, University of Utah

Brief Summary:
The investigator's plan to determine whether pre-operative skin preparation with hydrogen peroxide alters rates of P acnes culture positivity. They hypothesize that pre-operative skin preparation with hydrogen peroxide will reduce rates of P acnes culture positivity.

Condition or disease Intervention/treatment Phase
Propionibacterium Acnes Other: 3% hydrogen peroxide Not Applicable

Detailed Description:

Over half of all post-operative infections after shoulder arthroplasty are due to Propionibacterium acnes. Even in apparently "aseptic" revisions, nearly all cultures taken at the time of revision surgery are positive for P acnes, and thus low-grade infection with this bacteria may be a more common cause of failure than previously suspected. Current antibiotic prophylaxis methods are ineffective against P acnes. Despite intravenous cefazolin, P acnes can be cultured from the glenohumeral joint in 42% of patients undergoing primary total shoulder arthroplasty. Despite skin preparation with chlorhexidine, P acnes can be cultured from 73% of portal sites in arthroscopy. P acnes is further insensitive to alcohol. Dermatologists have long been treating P acnes as it is a primary cause of acne vulgaris. One of the most popular and effective treatments for acne vulgaris is topical benzoyl peroxide. A prior prospective clinical trial demonstrated that adding topical 5% benzoyl peroxide 48 hours prior to surgery reduced P acnes culture positivity to 6%. The downside of this treatment is that it must be applied by the patient, at home, for 48 hours prior to surgery. An additional downside is that benzoyl peroxide is a skin irritant that not all patients tolerate.

In aqueous environments, benzoyl peroxide rapidly decomposes into benzoic acid and hydrogen peroxide. Benzoic acid is a skin irritant and hydrogen peroxide is the active ingredient. Benzoyl peroxide is used instead of hydrogen peroxide because hydrogen peroxide breaks down into water and oxygen when exposed to light. Recently, stabilized forms of hydrogen peroxide have been developed and have been demonstrated to be equally effective to benzoyl peroxide in the treatment of acne vulgaris. One potential reason for hydrogen peroxide's efficacy against P acnes is that it is absorbed into the skin, addressing P acnes residing in sebaceous glands. To date, no studies have examined whether the addition of hydrogen peroxide to pre-operative skin preparation can reduce intra-operative P acnes culture positivity.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Does Hydrogen Peroxide Skin Preparation Reduce Propionibacterium Acnes in Shoulder Arthroplasty?
Actual Study Start Date : January 2017
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
No Intervention: Control
The control group will not receive any hydrogen peroxide skin preparation
Experimental: Treatment
The treatment group will also undergo skin preparation with 3% hydrogen peroxide.
Other: 3% hydrogen peroxide
The treatment group will also undergo skin preparation with 3% hydrogen peroxide.




Primary Outcome Measures :
  1. Positive P acnes culture [ Time Frame: 2-weeks ]
    The primary outcome of the study will be P acnes culture positive results.



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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing primary shoulder arthroplasty

Exclusion Criteria:

  • Patients with prior shoulder surgery.
  • Patients with a symptomatic infection or history of infection, recent antibiotic use (within six weeks), or with clinical signs of infection such as an elevated ESR, CRP, positive aspiration cultures, or positive biopsy.
  • Patients with a known hypersensitivity to hydrogen peroxide.

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): NCT03057821


Locations
United States, Utah
University of Utah Orthopaedic Center
Salt Lake City, Utah, United States, 84108
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Peter Chalmers, MD University of Utah

Responsible Party: Peter Chalmers, Principle Investigator, University of Utah
ClinicalTrials.gov Identifier: NCT03057821     History of Changes
Other Study ID Numbers: 96964
First Posted: February 20, 2017    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Peter Chalmers, University of Utah:
hydrogen peroxide
Propionibacterium Acnes
shoulder arthroplasty

Additional relevant MeSH terms:
Hydrogen Peroxide
Anti-Infective Agents, Local
Anti-Infective Agents