Propionibacterium Acnes in Shoulder Arthroplasty

• ClinicalTrials.gov Identifier: NCT03057821
• Recruitment Status: Completed
• First Posted: February 20, 2017
• Last Update Posted: August 30, 2019
• Sponsor: University of Utah
• Information provided by (Responsible Party): Peter Chalmers, University of Utah

Study Description

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 62 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
• Actual Primary Completion Date: March 2019
• Actual Study Completion Date: March 2019

Arms and Interventions

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.

Outcome Measures

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.

Eligibility Criteria

• 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.

Contacts and Locations

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

More Information

• Responsible Party: Peter Chalmers, Principle Investigator, University of Utah
• ClinicalTrials.gov Identifier: NCT03057821
• Other Study ID Numbers: 96964
• First Posted: February 20, 2017
• Last Update Posted: August 30, 2019
• Last Verified: August 2019

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:

Acne Vulgaris; Acneiform Eruptions; Skin Diseases; Sebaceous Gland Diseases; Hydrogen Peroxide; Anti-Infective Agents, Local; Anti-Infective Agents