Irrisept C.Acnes Study

Orthopaedic Associates of Michigan, PC

Status and phase: Completed; Phase 4

Conditions: Rate of Positive Culture Growth for C.Acnes From Specimens Obtained From the Shoulders of Patients Undergoing Primary Shoulder Arthroplasty

Treatments: Drug: Antiseptic Cleanser

Study type: Interventional

Funder types: Other

Identifiers

NCT03938467

RVO-IRR-2019

Details and patient eligibility

About

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

Full 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.

Enrollment: 58 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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58 participants in 2 patient groups

Antiseptic Cleanser

Experimental group

Description:

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.

Treatment:

Drug: Antiseptic Cleanser

Standard of Care Prophylaxis

No Intervention group

Description:

Standard prophylaxis includes use of chlorhexidine wipes (Sage cloth) the night before and morning of surgery on the surgical site over the anterior shoulder.