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Procedure

Wound Protectors for Shoulder Replacement Surgery

N/A

Waitlist Available

Led By Christopher Joyce, M.D.

Research Sponsored by University of Utah

Eligibility Criteria Checklist

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

Must have

Patients undergoing primary anatomic or reverse shoulder arthroplasty by one of three specified surgeons

Be older than 18 years old

Must not have

History of revision arthroplasty

History of ipsilateral shoulder infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2-weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to investigate whether using a wound protection device during shoulder replacement surgery can reduce the risk of infection and minimize soft tissue damage.

Who is the study for?

This trial is for individuals undergoing primary shoulder arthroplasty, aiming to see if using a wound protector can reduce deep wound bacterial contamination and soft tissue trauma during surgery.

What is being tested?

The study compares the effectiveness of an Alexis orthopaedic protector versus no protector in preventing joint infection after shoulder replacement surgery. Participants will be divided into two groups to assess differences in outcomes.

What are the potential side effects?

Since this trial involves a surgical procedure, potential side effects may include typical surgical risks such as pain, infection at the incision site, bleeding, or delayed healing. The use of the wound protector itself is not likely to cause additional side effects.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am having shoulder replacement surgery by a specified surgeon.

Exclusion Criteria

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

Select...

I have had a joint replacement surgery redone.

Select...

I have had an infection in my shoulder on the same side.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2-weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2-weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2-weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Positive C acnes culture

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Wound protectorExperimental Treatment1 Intervention

Wound protector group will have an insertion of a wound protector after making an initial superficial approach to the shoulder. During surgery 4 tissue swab cultures will be obtained and sent to a laboratory for analysis. The wound protector will then remain in place until the end of the case during wound closure.

Group II: Control - no wound protectorExperimental Treatment1 Intervention

The (control - no wound protector) will not use the protector device during the course of the surgery. During surgery 4 tissue swab cultures will be obtained and sent to a laboratory for analysis.

0 / 3Eligibility criteria met