A Prospective, Randomized, Controlled Trial Comparing An Irrisept Antiseptic Irrigation With 0.05% Chlorhexidine Gluconate versus Standard of Care Prophylaxis Chlorohexidine Wipes
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
58
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.
Orthopaedic Associates of Michigan, PC
Grand Rapids, Michigan, United States
C.acnes Growth Rate
To compare the rate of C.acnes using two different antiseptic protocols
Time frame: 12 months
Visual Analog Scale (VAS)
Assessment of clinical/subjective feedback via questionnaires during the postoperative follow up period. VAS assessment: \[0 (no pain) - 10 (worse possible pain)\]
Time frame: 6 months
ROM
Range of Motion
Time frame: 6 Months
American Shoulder and Elbow Surgeons Shoulder Score (ASES)
the Society of the American Shoulder and Elbow Surgeons to facilitate standardization of outcome measures.
Time frame: 6 Months
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