Wound Irrigation Comparative Effectiveness Study

Recruiting now · Not applicable

Conditions studied: Cutibacterium Acnes Contamination

In brief

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.

Key facts

Study ID

NCT06379919

Run by

Orthopaedic Education and Research Institute (dba Hoag Orthopedics)

People needed

126

Starts

2024-03-20

Expected to finish

2027-05-31

Last updated by the study team

2024-04-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Ault patients requiring Total Shoulder Arthroplasty

You may not qualify if…

• 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

Where it is running

• Hoag Orthopedics — Orange, California, United States (enrolling)

Full record on ClinicalTrials.gov

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