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Wound Irrigation Comparative Effectiveness Study

Recruiting
18 years of age
Both
Phase N/A

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Overview

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 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

Study details

Cutibacterium Acnes Contamination

NCT06379919

Orthopaedic Education and Research Institute (dba Hoag Orthopedics)

30 April 2024

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