Title
Irrisept C.Acnes Study
Effect of Antiseptic Irrigation With 0.05% Chlorhexidine Gluconate (Irrisept) on Incidence of Cutibacterium Acnes in Shoulder Arthroplasty
Phase
Phase 4Lead Sponsor
Orthopaedic Associates of Michigan, PCStudy Type
InterventionalStatus
Unknown statusIntervention/Treatment
Antiseptic CleanserStudy Participants
100A 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.
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.
Standard prophylaxis will be administered by Irrisept patients as would individuals in the control group. In addition, these Irrisept study subjects will be supplemented with the use of Irrisept irrigation by the study surgeon during the patient's surgical procedure. Standard times for irrigation will include immediately after incision through the dermal layer, and immediately prior to implantation of any prosthetic components. Final irrigation will be performed just prior to closure of the deltopectoral interval.
Standard prophylaxis includes use of chlorhexidine wipes (Sage cloth) the night before and morning of surgery on the surgical site over the anterior shoulder.
Inclusion Criteria: Patient has signed the IRB-approved informed consent form specific to this study prior to undergoing any research related procedures Patient can read and understand English Patient who will undergo a primary shoulder arthroplasty Patient is over the age of 18 Exclusion Criteria: Patient who has had a previous surgery on the ipsilateral shoulder Patient has a known allergy to topical iodine or Chlorohexidine gluconate. Patient has had non-surgical prophylaxis antibiotic treatment within 14 days of index surgery Patient requires a revision procedure for a previous ipsilateral shoulder surgery Patient has any significant pathology that, in the opinion of investigator, makes the patient unsuitable for study participation Patient is a pregnant woman
