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Wound Irrigation Comparative Effectiveness Study

Orthopaedic Education and Research Institute (dba Hoag Orthopedics) · with Irrimax Corporation · NCT06379919

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
126
US sites recruiting
1
Study start
March 20, 2024
Record last updated
April 26, 2024

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Irrisept Irrigation; Saline Irrigation Solution Delivery

Conditions: Cutibacterium Acnes Contamination

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • Hoag Orthopedics

    Orange, CA 92868

    Site contact: Edward Quilligan, BS · 949-526-1570 · Edward.quilligan@hoagorthopedics.org

Study contacts (from the official record)

  • Vance Gardner, MD · (949) 526-1570 · anabaino77@gmail.com
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Wound Irrigation Comparative Effectiveness Study (NCT06379919) | Bored Studies