Rate of Positive Culture Growth for C.Acnes From Specimens Obtained From the Shoulders of Patients Undergoing Primary Shoulder Arthroplasty
Conditions
Keywords
Shoulder Arthroplasty, C.acnes, Cutibacterium acnes, Irrisept
Brief summary
A Prospective, Randomized, Controlled Trial Comparing An Irrisept Antiseptic Irrigation With 0.05% Chlorhexidine Gluconate versus Standard of Care Prophylaxis Chlorohexidine Wipes
Detailed description
The purpose of this prospective randomized control trial is to access outcomes of positive culture growth of C. acnes from specimens obtained from the shoulders of patients undergoing primary shoulder arthroplasty whose intraoperative management includes Irrisept antiseptic irrigation and compare it to patients whose management includes standard of care prophylaxis wipes.
Interventions
DRUGAntiseptic Cleanser
Contains 0.05% Chlorhexidine gluconate in sterile water for irrigation. The mechanical action of the Irrisept system removes bacteria and debris without harming underlying tissues. Irrisept has demonstrated broad spectrum bactericidal activity against antibiotic-resistant strains. Its contents are wrapped in two sequential sterilization wraps which repel water blood, and saline, making it effective against both air and water borne bacteria.
Sponsors
Mercy Health
Orthopaedic Associates of Michigan, PC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Intervention model description
Prospective, Randomized, Controlled Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Patient has signed the IRB-approved informed consent form specific to this study prior to undergoing any research related procedures 2. Patient can read and understand English 3. Patient who will undergo a primary shoulder arthroplasty 4. Patient is over the age of 18
Exclusion criteria
1. Patient who has had a previous surgery on the ipsilateral shoulder 2. Patient has a known allergy to topical iodine or Chlorohexidine gluconate. 3. Patient has had non-surgical prophylaxis antibiotic treatment within 14 days of index surgery 4. Patient requires a revision procedure for a previous ipsilateral shoulder surgery 5. Patient has any significant pathology that, in the opinion of investigator, makes the patient unsuitable for study participation 6. Patient is a pregnant woman
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| C.acnes Growth Rate | 12 months | To compare the rate of C.acnes using two different antiseptic protocols |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) | 6 months | Assessment of clinical/subjective feedback via questionnaires during the postoperative follow up period. VAS assessment: \[0 (no pain) - 10 (worse possible pain)\] |
| ROM | 6 Months | Range of Motion |
| American Shoulder and Elbow Surgeons Shoulder Score (ASES) | 6 Months | the Society of the American Shoulder and Elbow Surgeons to facilitate standardization of outcome measures. |
Countries
United States
Outcome results
None listed