Propionibacterium Acnes in Shoulder Arthroplasty

Does Hydrogen Peroxide Skin Preparation Reduce Propionibacterium Acnes in Shoulder Arthroplasty?

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.

Study Overview

• Status: Completed
• Conditions: Propionibacterium Acnes
• Intervention / Treatment: Other: 3% hydrogen peroxide

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
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84108
      • University of Utah Orthopaedic Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive P acnes culture	The primary outcome of the study will be P acnes culture positive results.	2-weeks

Collaborators and Investigators

• Sponsor: University of Utah
• Investigators: Principal Investigator: Peter Chalmers, MD, University of Utah

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): March 1, 2019
• Study Completion (Actual): March 1, 2019

Study Registration Dates

• First Submitted: February 14, 2017
• First Submitted That Met QC Criteria: February 15, 2017
• First Posted (Actual): February 20, 2017

Study Record Updates

• Last Update Posted (Actual): August 30, 2019
• Last Update Submitted That Met QC Criteria: August 29, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: hydrogen peroxide; shoulder arthroplasty; Propionibacterium Acnes
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Anti-Infective Agents, Local; Anti-Infective Agents; Hydrogen Peroxide
• Other Study ID Numbers: 96964

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No