NCT06379919NARecruitingAccepts Healthy Volunteers

Wound Irrigation Comparative Effectiveness Study

Orthopaedic Education and Research Institute (dba Hoag Orthopedics)

Start Date

3/20/2024

Completion Date

5/31/2027

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 Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: • Ault patients requiring Total Shoulder Arthroplasty Exclusion Criteria: * 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

Interventions

PROCEDURE

Irrisept Irrigation

PROCEDURE

Saline Irrigation Solution Delivery

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Conditions

Cutibacterium Acnes Contamination

Locations

Hoag Orthopedics

Orange, California 92868

United States