Comparing two methods of wound irrigation for shoulder surgery
Cutibacterium Acnes Removal by Wound Irrigation With Normal Saline Versus Irrisept During Total Shoulder Arthroplasty
NA · Orthopaedic Education and Research Institute (dba Hoag Orthopedics) · NCT06379919
This study is testing whether using Normal Saline or Irrisept for cleaning wounds during shoulder surgery can help reduce bacteria and improve recovery for patients.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 126 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Orthopaedic Education and Research Institute (dba Hoag Orthopedics) (other) |
| Locations | 1 site (Orange, California) |
| Trial ID | NCT06379919 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of two different irrigation solutions, Normal Saline and Irrisept, in reducing Cutibacterium acnes contamination in patients undergoing Total Shoulder Arthroplasty. Participants will have bacteriologic cultures taken from subcutaneous and deep tissue before the irrigation procedure. Additionally, the study will assess patient-reported outcomes and range of motion related to the presence of C acnes in both groups. The goal is to determine which irrigation method is more effective in minimizing bacterial contamination.
Who should consider this trial
Good fit: Ideal candidates for this study are adult patients aged 18 and older who are scheduled for Total Shoulder Arthroplasty.
Not a fit: Patients with a history of shoulder infection, those currently on antibiotic therapy, or individuals who are immunocompromised may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced infection rates for patients undergoing shoulder surgery.
How similar studies have performed: Other studies have explored various irrigation methods in surgical settings, but this specific comparison of Irrisept and Normal Saline is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Orange, California
- Hoag Orthopedics — Orange, California, United States (RECRUITING)
Study contacts
- Principal investigator: Hafiz F Kassam, MD — Hoag Orthopedics Education and Research
- Study coordinator: Vance Gardner, MD
- Email: anabaino77@gmail.com
- Phone: (949) 526-1570
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cutibacterium Acnes Contamination