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 range

18 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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