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Antimicrobial Wash for Shoulder Replacement Surgery

Detroit, MI

N/A

Waitlist Available

Research Sponsored by Henry Ford Health System

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥18 years

Indicated and scheduled for primary shoulder arthroplasty

Must not have

Prior surgery of affected shoulder

Patient with history of prior native shoulder septic arthritis or infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year postop

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study the effect of using different antimicrobial solutions after shoulder replacement surgery on the presence of bacteria called C. Acnes. Patients will be randomly assigned to receive one of four treatments:

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Who is the study for?

This trial is for adults undergoing primary shoulder replacement surgery. The study aims to see if washing the surgical site with different antimicrobial solutions after making an incision can reduce bacteria levels.Check my eligibility

What is being tested?

Participants will be randomly assigned to one of four groups: those receiving a post-incision wash with Xperience Antimicrobial, hydrogen peroxide, povidone-iodine, or no treatment (control). The goal is to compare the effectiveness in reducing P. Acnes bacteria.See study design

What are the potential side effects?

Potential side effects may include skin irritation or allergic reactions at the application site due to antimicrobial solutions like hydrogen peroxide and povidone-iodine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am scheduled for a first-time shoulder replacement surgery.

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I have severe shoulder joint damage due to arthritis, injury, or other conditions.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had surgery on my shoulder before.

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I have had an infection in my shoulder joint before.

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I have a broken upper arm bone near the shoulder.

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I currently have an infection.

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I have an autoimmune or rheumatologic disorder like rheumatoid arthritis.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year postop

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year postop

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year postop for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of C. Acnes

Secondary study objectives

Number and Types of Complications

Number of Subjects that Require Postoperative Reoperations

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Xperience Antimicrobial WashExperimental Treatment3 Interventions

Xperience Antimicrobial Wash is composed of 32.5 g/L citric acid, 31.3 g/L sodium citrate, and 1.00 g/L sodium lauryl sulfate in sterile water. It is to be applied along the entire dermis using a soaked surgical sponge following initial incision.

Group II: 3% hydrogen peroxideExperimental Treatment3 Interventions

To be applied along the entire dermis using a soaked surgical sponge following initial incision.

Group III: 10% povidone-iodineExperimental Treatment3 Interventions

To be applied along the entire dermis using a soaked surgical sponge following initial incision.

Group IV: ControlActive Control2 Interventions

No treatment of the dermal layer will be performed prior to a collection of the bacterial cultures

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Povidone-Iodine

2017