Irrisept C.Acnes Study

  • STATUS
    Recruiting
  • End date
    Oct 1, 2023
  • participants needed
    100
  • sponsor
    Orthopaedic Associates of Michigan, PC
Updated on 5 June 2021

Summary

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

Description

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.

Details
Condition Rate of Positive Culture Growth for C.Acnes From Specimens Obtained From the Shoulders of Patients Undergoing Primary Shoulder Arthroplasty, Rate of Positive Culture Growth for C.Acnes From Specimens Obtained From the Shoulders of Patients Undergoing Primary Shoulder Arthroplasty
Treatment Antiseptic Cleanser
Clinical Study IdentifierNCT03938467
SponsorOrthopaedic Associates of Michigan, PC
Last Modified on5 June 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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