Antiseptic Cleanser for Rate of C.Acnes Growth From Shoulder Specimens in Primary Shoulder Arthroplasty Patients

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Rate of C.Acnes Growth From Shoulder Specimens in Primary Shoulder Arthroplasty PatientsAntiseptic Cleanser - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial found that using an irrisept antiseptic irrigation is more effective at preventing infection than using chlorhexidine gluconate wipes.

Eligible Conditions
  • Rate of C.Acnes Growth From Shoulder Specimens in Primary Shoulder Arthroplasty Patients

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 12 months

12 months
C.acnes Growth Rate
6 Months
American Shoulder and Elbow Surgeons Shoulder Score (ASES)
ROM
6 months
Visual Analog Scale (VAS)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Standard of Care Prophylaxis
1 of 2
Antiseptic Cleanser
1 of 2

Active Control

Experimental Treatment

100 Total Participants · 2 Treatment Groups

Primary Treatment: Antiseptic Cleanser · No Placebo Group · Phase 4

Antiseptic Cleanser
Drug
Experimental Group · 1 Intervention: Antiseptic Cleanser · Intervention Types: Drug
Standard of Care ProphylaxisNoIntervention Group · 1 Intervention: Standard of Care Prophylaxis · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months

Who is running the clinical trial?

Orthopaedic Associates of Michigan, PCLead Sponsor
3 Previous Clinical Trials
697 Total Patients Enrolled
Mercy HealthOTHER
4 Previous Clinical Trials
373 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
A patient who needs a shoulder replacement surgery is scheduled to have a "primary" shoulder arthroplasty
and has capacity to give consent The patient is over the age of 18 and is able to make decisions for themselves.
The patient can read and understand English.
You have signed the IRB-approved informed consent form specific to this study prior to undergoing any research related procedures.
References