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

Phase 4

Recruiting

• Conditions: Total Shoulder Arthroplasty; Rotator Cuff Injury; Shoulder Osteoarthritis; Surgery - Other surgery; Skin - Other skin conditions; Infection - Other infectious diseases; Musculoskeletal - Osteoarthritis; Injuries and Accidents - Other injuries and accidents

• Registration Number: ACTRN12618000261213
• Lead Sponsor: Orthopaedic Research Institute Queensland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-02-20
• Last Update Posted: 10 December 2018

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 105

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
This is a composite primary outcome. To quantify the effects of benzyl peroxide and benzyl peroxide with clindamycin skin prep preoperatively on the ability to reduce superficial colonization and deep tissue inoculation of Propionibacterium. acnes (P. acnes).[Pre-op and intraoperatively swabs will be taken to determine positive P. acnes culture rate.]

Secondary Outcome Measures

Name	Time	Method
To determine the rate of P. Acnes contamination in primary total shoulder arthroplasty.[Following growth of cultures taken intra-operatively - assessed by swabs of shoulder skin area and deep swabs];To determine the level of compliance relating to application of 3 different shoulder preparations prior to arthroplasty.[Compliance with the various skin preparations will be completed at the 2 week follow-up via survey.<br>];To determine the rate of P. Acnes innoculation in primary total shoulder arthroplasty.[Following growth of cultures taken intra-operatively - assessed by swabs of shoulder skin area and deep swabs]