None listed
Conditions
Brief 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.
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
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.
Sponsors
Orthopaedic Research Institute Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
30 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
Inclusion criteria: 1. Male or Female 2. Age 30-90 a. This age range depicts the typical population that undergo total shoulder arthroplasty. Participants less than 30 years are not amenable to a total shoulder arthroplasty. Patients older than 90 years often have much higher co-morbidity and have an increased risk of complications and thus do not typically have total shoulder arthroplasty. 4. Patients who require a primary TSA for treatment of OA or rotator cuff injuries
Exclusion criteria
Exclusion criteria include: Patients with active infection Patients with BMI >40, (may impact on study) Patients who are pregnant or planning on becoming pregnant during the course of the study Patients unable to provide informed consent Patients who have undergone previous arthroplasty, have had previous infection, previous surgical procedures or injection into the shoulder within the previous 6 months prior to surgery. Patients with documented allergy to any of the skin preparation solutions Patients with English as second language unless understanding English proficiently or a translator service is available
Outcome results
None listed