Surgiphor for Shoulder Replacement Surgery

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Rothman Institute Orthopaedics

Disqualifiers: Prior shoulder surgery, Iodine allergy, Active infection, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

126 Participants Needed

Trial Summary

What is the purpose of this trial?

Bacteria is occasionally present in the shoulder during shoulder arthroplasty surgery and is hypothesized to increase the risk of failure of the prosthesis. Surgiphor (sterile Povidone-Iodine) wound irrigation, is a solution used in orthopaedic surgery and other surgical fields to kill bacteria intraoperatively. The Iodine dissociates from complex and has antimicrobial properties, causing cell death of bacteria, fungi, and viruses through interactions with proteins, nucleotides, and fatty acids in the cytoplasm and cytoplasmic membrane. This study examines the use of Povidone-Iodine during primary shoulder arthroplasty.

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

The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Eligibility Criteria

This trial is for individuals undergoing total shoulder replacement who may be at risk of infection. Participants must not have an allergy to iodine, as the treatment involves Povidone-Iodine, which contains this element.

Inclusion Criteria

Participants willing to provide written consent

I am over 18 years old.

I am scheduled for my first total shoulder replacement surgery.

Exclusion Criteria

Known allergy to povidone iodine, iodine or shellfish

Participation in other clinical trials

I have had surgery on my shoulder before.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo primary total shoulder arthroplasty with wound irrigation using either Surgiphor or sterile normal saline

1 day

1 visit (in-person)

Follow-up

Participants are monitored for clinical signs of infection and reduction of positive cultures

90 days

Treatment Details

Interventions

• Surgiphor

Trial Overview The study is testing Surgiphor (sterile Povidone-Iodine) for irrigating the surgical site during shoulder arthroplasty to see if it can kill bacteria and reduce infection risk. The effectiveness will be compared with using a sterile saline solution.

Participant Groups

Group I: Total Shoulder Arthroplasty washed with Surgiphor (Povidone Iodine) Active Control 2 Interventions

This arm will consist of Surgiphor to be used before and after placement of shoulder arthroplasty components

Group II: Total Shoulder Arthroplasty washed with Saline Active Control 2 Interventions

This arm will consist of sterile normal saline to be used before and after placement of shoulder arthroplasty components

Who Is Running the Clinical Trial?

Rothman Institute Orthopaedics

Lead Sponsor

Trials

127

Recruited

22,600+