Wound Protectors for Shoulder Replacement Surgery

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Disqualifiers: Revision arthroplasty, Shoulder infection, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

100 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

How is the Alexis orthopaedic protector treatment different from other treatments for shoulder replacement surgery?

The Alexis orthopaedic protector is unique because it acts as a wound protector during surgery, helping to prevent bacterial contamination and reduce the risk of infection by lining the incision site. This approach is different from traditional methods that may not specifically focus on protecting the wound from contamination during the procedure. ^{1 2 3 4 5}

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.

Research Team

Christopher Joyce, M.D.

Principal Investigator

University of Utah Orthopaedics

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo shoulder arthroplasty with or without the use of a wound protector. Tissue swab cultures are obtained during surgery.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for positive C acnes culture results and any signs of infection.

2 weeks

Treatment Details

Interventions

• Alexis orthopaedic protector

Trial Overview 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.

Participant Groups

Group I: Wound protector Experimental Treatment 1 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 protector Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Randomized, controlled investigation of the anti-infective properties of the Alexis retractor/protector of incision sites. [2007]

2. United States pubmed.ncbi.nlm.nih.gov

Effect of Soft Silicone Foam Dressings on Intraoperatively Acquired Pressure Injuries: A Randomized Study in Patients Undergoing Spinal Surgery. [2021]

3. Mexico pubmed.ncbi.nlm.nih.gov

Usefulness of a circumferential wound retractor in emergency colorectal surgery as a preventive measure for surgical site infection. Alexis O-Ring® and emergency surgery. [2021]

4. Germany pubmed.ncbi.nlm.nih.gov

Plastic wound protectors do not affect wound infection rates following laparoscopic-assisted colectomy. [2019]

5. Belgium pubmed.ncbi.nlm.nih.gov

Another string.... but no bow. [2011]