Wound Irrigation Comparative Effectiveness Study
Cutibacterium Acnes Removal by Wound Irrigation With Normal Saline Versus Irrisept During Total Shoulder Arthroplasty
Orthopaedic Education and Research Institute (dba Hoag Orthopedics)
126 participants
Mar 20, 2024
INTERVENTIONAL
Conditions
Summary
The primary objective of this study is to compare the presence of C acnes in bacteriologic cultures taken from participant samples of subcutaneous and deep tissue prior to deep surgical irrigation using either Normal Saline Irrigation (Group 1) or Irrisept Irrigation (Group 2). Secondary objectives are evaluation of patient reported outcome measures and range of motion in relation to C acnes presence among subjects in the two groups.
Eligibility
Inclusion Criteria1
- • Ault patients requiring Total Shoulder Arthroplasty
Exclusion Criteria7
- Age younger than 18 years
- History of shoulder infection
- Antibiotic therapy within 2 weeks of surgery
- Cortisone infiltration within 3 months prior to surgery
- Allergy to CHG
- Diagnosis of rheumatoid arthritis
- Immunocompromised patients
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Interventions
Irrisept Antimicrobial Wound Lavage is a single-use, manual, self-contained irrigation device. Irrisept contains 0.05% Chlorhexidine Gluconate (CHG) in 99.95% Sterile Water for Irrigation, United Staes Pharmacopeia (USP). The solution is aseptically filled in a Blow-Fill-Seal (BFS) bottle.
Normal saline is isotonic and the most commonly used wound irrigation solution due to safety (lowest toxicity) and physiologic factors.
Locations(1)
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NCT06379919