CompletedPhase 4

Irrisept C.Acnes Study

United States58 participantsStarted 2021-03-01

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

C.acnes Growth Rate

Timeframe: 12 months

Trial details

NCT IDNCT03938467

SponsorOrthopaedic Associates of Michigan, PC

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-07-01

View on ClinicalTrials.gov More Rate of Positive Culture Growth for C.Acnes From Specimens Obtained From the Shoulders of Patients Undergoing Primary Shoulder Arthroplasty trials