Wound Irrigation Comparative Effectiveness Study

Last updated: April 24, 2024
Sponsor: Orthopaedic Education and Research Institute (dba Hoag Orthopedics)
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Irrisept Irrigation

Saline Irrigation Solution Delivery

Clinical Study ID

NCT06379919
C Acnes in TSA
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Inclusion

Inclusion Criteria:

• Ault patients requiring Total Shoulder Arthroplasty

Exclusion

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 Design

Total Participants: 126
Treatment Group(s): 2
Primary Treatment: Irrisept Irrigation
Phase:
Study Start date:
March 20, 2024
Estimated Completion Date:
May 31, 2027

Connect with a study center

  • Hoag Orthopedics

    Orange, California 92868
    United States

    Active - Recruiting

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