Actively Recruiting
Wound Irrigation Comparative Effectiveness Study
Led by Orthopaedic Education and Research Institute (dba Hoag Orthopedics) · Updated on 2024-04-26
126
Participants Needed
1
Research Sites
166 weeks
Total Duration
On this page
Sponsors
O
Orthopaedic Education and Research Institute (dba Hoag Orthopedics)
Lead Sponsor
I
Irrimax Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Wound Irrigation Comparative Effectiveness Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients requiring Total Shoulder Arthroplasty
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hoag Orthopedics
Orange, California, United States, 92868
Actively Recruiting
Research Team
V
Vance Gardner, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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