Wound Protectors for Shoulder Replacement Surgery

Recruiting in Palo Alto (17 mi)

Overseen byChristopher Joyce, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Utah

No Placebo Group

Trial Summary

What is the purpose of this trial?Prosthetic joint infection is a devastating complication of shoulder arthroplasty. A relatively novel method of preventing PJI has been with the use of a wound protection device. There is minimal investigative research on the use of a wound protector in shoulder arthroplasty, specifically with an ability to decrease wound contamination. The investigators primary purpose of the proposed study is to determine if the use of a wound protector deceases the deep wound colonization of bacteria in primary shoulder arthroplasty. A secondary purpose is to evaluate if the wound protector decreases soft tissue trauma during total shoulder arthroplasty.

Eligibility Criteria

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.

Inclusion Criteria

I am having shoulder replacement surgery by a specified surgeon.

Exclusion Criteria

I have had a joint replacement surgery redone.

Patients unable or unwilling to consent

Employees of the University of Utah

+5 more

Participant Groups

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.

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.