Propionibacterium Acnes in Shoulder Arthroplasty
Primary Purpose
Propionibacterium Acnes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
3% hydrogen peroxide
Sponsored by
About this trial
This is an interventional other trial for Propionibacterium Acnes focused on measuring hydrogen peroxide, Propionibacterium Acnes, shoulder arthroplasty
Eligibility 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.
Sites / Locations
- University of Utah Orthopaedic Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Treatment
Arm Description
The control group will not receive any hydrogen peroxide skin preparation
The treatment group will also undergo skin preparation with 3% hydrogen peroxide.
Outcomes
Primary Outcome Measures
Positive P acnes culture
The primary outcome of the study will be P acnes culture positive results.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03057821
Brief Title
Propionibacterium Acnes in Shoulder Arthroplasty
Official Title
Does Hydrogen Peroxide Skin Preparation Reduce Propionibacterium Acnes in Shoulder Arthroplasty?
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
March 2019 (Actual)
Study Completion Date
March 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Propionibacterium Acnes
Keywords
hydrogen peroxide, Propionibacterium Acnes, shoulder arthroplasty
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
The control group will not receive any hydrogen peroxide skin preparation
Arm Title
Treatment
Arm Type
Experimental
Arm Description
The treatment group will also undergo skin preparation with 3% hydrogen peroxide.
Intervention Type
Other
Intervention Name(s)
3% hydrogen peroxide
Intervention Description
The treatment group will also undergo skin preparation with 3% hydrogen peroxide.
Primary Outcome Measure Information:
Title
Positive P acnes culture
Description
The primary outcome of the study will be P acnes culture positive results.
Time Frame
2-weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Chalmers, MD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah Orthopaedic Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Propionibacterium Acnes in Shoulder Arthroplasty
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