Wound Irrigation Study for Shoulder Surgery

This study is looking at two different ways to clean wounds during total shoulder replacement surgery to see which is better at preventing a common bacteria called *Cutibacterium acnes* (*C. acnes*). You might be able to join if you are an adult needing total shoulder replacement surgery and haven't had recent infections, certain medications, or conditions like rheumatoid arthritis. The study will compare Irrisept Irrigation, which contains a germ-killing ingredient called Chlorhexidine Gluconate (CHG), to normal saline irrigation. Researchers will check for *C. acnes* in tissue samples taken during surgery and for 21 days afterward to see which irrigation method is more effective. They will also look at how you feel and your shoulder's movement.

Study design
This interventional study plans to enroll 126 adult patients. It compares two different wound irrigation methods during total shoulder arthroplasty.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The presence of *C. acnes* will be analyzed over 21 days post-surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06379919

Wound Irrigation Comparative Effectiveness Study

Recruiting
NAAges 18+InterventionalTreatment
Orthopaedic Education and Research Institute (dba Hoag Orthopedics)
~126 participants
Updated 2024-04-26 on ClinicalTrials.gov
What's tested:Irrisept IrrigationSaline Irrigation Solution Delivery

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
C Acnes Presence
Measured over Cultures take during surgery and analyzed over 21 days post surgery
Cutibacterium Acnes Contamination

NCT06379919

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Hoag Orthopedics

    Orange, Californiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Hafiz F Kassam, MD · PRINCIPAL_INVESTIGATOR · Hoag Orthopedics Education and Research

Opens a ready-to-send draft in your own email app — review before sending.

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Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Exclusion

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
  • C Acnes PresenceCultures take during surgery and analyzed over 21 days post surgery

    The primary outcome 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)rimary objecti