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Antiseptic

Antiseptic Cleanser for C. Acnes Growth in Shoulder Arthroplasty Patients

Phase 4
Waitlist Available
Research Sponsored by Orthopaedic Associates of Michigan, PC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
C.acnes Growth Rate
Secondary outcome measures
American Shoulder and Elbow Surgeons Shoulder Score (ASES)
ROM
Visual Analog Scale (VAS)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Antiseptic CleanserExperimental Treatment1 Intervention
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.
Group II: Standard of Care ProphylaxisActive Control1 Intervention
Standard prophylaxis includes use of chlorhexidine wipes (Sage cloth) the night before and morning of surgery on the surgical site over the anterior shoulder.

Find a Location

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

Media Library

Irrisept Antiseptic Irrigation with 0.05% Chlorhexidine Gluconate (Antiseptic) Clinical Trial Eligibility Overview. Trial Name: NCT03938467 — Phase 4
C. Acnes Growth in Shoulder Arthroplasty Patients Research Study Groups: Antiseptic Cleanser, Standard of Care Prophylaxis
C. Acnes Growth in Shoulder Arthroplasty Patients Clinical Trial 2023: Irrisept Antiseptic Irrigation with 0.05% Chlorhexidine Gluconate Highlights & Side Effects. Trial Name: NCT03938467 — Phase 4
Irrisept Antiseptic Irrigation with 0.05% Chlorhexidine Gluconate (Antiseptic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03938467 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it currently possible to join this clinical investigation?

"Indeed, clinicaltrials.gov verifies that this trial is currently recruiting participants. It was first published on March 1st 2021 and has since been updated on May 20th 2021. The target sample size for the study is 100 patients from a single medical centre."

Answered by AI

What is the quota for enrollees in this trial?

"Affirmative. According to clinicaltrials.gov, the trial which was initially launched on March 1st 2021 is currently recruiting patients. An estimated 100 participants must be sourced from a single medical facility before this study can proceed further."

Answered by AI

What deleterious effects has Antiseptic Cleanser been shown to have on individuals?

"The usage of Antiseptic Cleanser has been approved, thus it received a rating of 3 on the safety scale."

Answered by AI
Recent research and studies
~25 spots leftby Mar 2025