Cutibacterium Acnes Contamination
Conditions
Brief 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.
Interventions
PROCEDUREIrrisept Irrigation
Irrisept Antimicrobial Wound Lavage is a single-use, manual, self-contained irrigation device. Irrisept contains 0.05% Chlorhexidine Gluconate (CHG) in 99.95% Sterile Water for Irrigation, United Staes Pharmacopeia (USP). The solution is aseptically filled in a Blow-Fill-Seal (BFS) bottle.
PROCEDURESaline Irrigation Solution Delivery
Normal saline is isotonic and the most commonly used wound irrigation solution due to safety (lowest toxicity) and physiologic factors.
Sponsors
Irrimax Corporation
Orthopaedic Education and Research Institute (dba Hoag Orthopedics)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants and Microbiology lab assessing cultures are blinded to the assigned irrigation treatment arm throughout the length of the study.
Intervention model description
Participants are assigned at the beginning of the study to treatment arm involving 1 of 2 types of irrigation treatment for their surgery. They continue in that arm through the length of the study and complete the same study procedures, as well as same standard of care.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| C Acnes Presence | Cultures 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| American Shoulder and Elbow Surgeons Patient Reported Outcome Measure | Pre-operation, 3, 6, 12, & 24 Months post-operation, | This assessment consists of 17, multiple choice questions that pertain to pain and function of the operated shoulder. |
| Shoulder Range of Motion (ROM) | Pre-operation, 3, 6, 12, & 24 Months post-operation, | Shoulder Range of Motion will require the Investigator or Designee to evaluate the following degrees of freedom: Forward flexion External Rotation with elbow at side External Rotation with elbow at 900 Internal Rotation as measured by spinal segment reached. |
Countries
United States
Contacts
Primary ContactVance Gardner, MD
Outcome results
None listed