RecruitingPhase 4ACTRN12618000261213

The efficacy of topical preparations in reducing the incidence of P. Acnes in total shoulder arthroplasty

Sponsor

Orthopaedic Research Institute Queensland

Enrollment

105 participants

Start Date

Jul 16, 2018

Study Type

Interventional

Conditions

Total Shoulder Arthroplasty Shoulder Osteoarthritis

Summary

Elective total shoulder arthroplasty (TSA) is a common and effective orthopaedic procedure for the treatment of osteoarthritis and rotator cuff injuries. Infection remains a common reason for surgical revision. A common bacteria causing these infection is Propionibacterium Acnes. The current method to reduce post op infections is to use skin preparations prior to surgery. This standard surgical prophylaxis does not seem to decrease the bacterial load. This may be a potential source of infection for susceptible patients having procedures with surgical implants. Benzyl Peroxide (BPO) and Benzyl Peroxide/Clindamycin (BPO/C) topical skin preparations have been shown to reduce the superficial skin colonization of P. acnes. This study aims to investigate the use of BPO and BPO/C as a topical skin preparation and to determine the effects it has in reducing positive cultures in patients undergoing TSA. Study Outcomes • Contamination and inoculation with P. Acnes will be determined via microbiological analysis. Positive cultures will be noted and compared statistically between groups. From this data efficacy between preparations can be determined. • Compliance with the various skin preparations will be completed at the 2 week follow-up via survey.

Eligibility

Sex: Both males and femalesMin Age: 30 YearssMax Age: 90 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether applying medicated skin preparations — benzoyl peroxide (BPO) alone, or benzoyl peroxide combined with clindamycin (BPO/C) — to the shoulder skin before total shoulder replacement surgery can reduce the level of a specific bacteria called Propionibacterium acnes. This bacteria naturally lives on shoulder skin and is a common cause of infection after shoulder joint replacement surgery. Infection after joint replacement is serious and often requires repeat surgery. Participants apply the skin preparation at home in the days before their scheduled operation. You may be eligible if: - You are aged 30 to 90 years - You are male or female - You require primary total shoulder replacement surgery for osteoarthritis or rotator cuff injuries You may NOT be eligible if: - You have an active infection - Your BMI is above 40 - You are pregnant or planning to become pregnant during the study - You have had a previous shoulder replacement, previous infection, previous surgery, or a shoulder injection in the past 6 months - You have a documented allergy to the skin preparation solutions Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

This study aims to investigate the use of BPO and BPO/C as a topical skin preparation and to determine the effects it has in reducing positive superficial and deep cultures in patients undergoing TSA. 3 Groups. 1. Benzoyl Peroxide 5% Gel 2. Phisohex wash (1% triclosan, sodium benzoate 5mg/ml, benzyl alcohol 5mg/ml) 3. Benzoyl Peroxide 5% Gel with Clindamycin Gel 1% All these are topical skin applications. Patients are to apply morning and night starting two days prior to surgery and applying their last application the morning of surgery. (Total of 5 applications) The Gel/wash is to be applied liberally to the entire shoulder area as instructed by study investigators and explained with pictures in the patient information consent form document.