Irrisept C.Acnes Study

• Status: Recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: All

Summary

A Prospective, Randomized, Controlled Trial Comparing An Irrisept Antiseptic Irrigation With 0.05% Chlorhexidine Gluconate versus Standard of Care Prophylaxis Chlorohexidine Wipes

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Orthopaedic Associates of Michigan, PC
• Collaborators: Irrimax Corporation; Mercy Health
• Treatments: Anti-Infective Agents, Local; Chlorhexidine; Chlorhexidine gluconate

Criteria

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