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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether Surgiphor, a Povidone-Iodine solution, can reduce infection risk during shoulder replacement surgery. Researchers will compare two groups: one using Surgiphor and the other using a saline solution during surgery. The goal is to determine if Surgiphor more effectively prevents bacterial complications. This trial may suit adults planning elective shoulder replacement surgery, who have not had prior surgery on that shoulder and are not allergic to iodine. As a Phase 4 trial, this research involves an FDA-approved treatment and aims to understand how Surgiphor benefits more patients.

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.

What is the safety track record for Surgiphor?

Research has shown that Povidone-Iodine, the main ingredient in Surgiphor, is safe for use in surgeries. In a study of over 400 joint surgeries, Povidone-Iodine was used without major safety issues, and patients did not report serious side effects. This indicates that Surgiphor is likely safe for shoulder joint replacement surgery.

Povidone-Iodine is also used in various surgeries because it effectively kills bacteria, fungi, and viruses, helping to prevent infections. Its continued use in surgeries supports its safety. While Surgiphor is specifically tested for shoulder replacements, its established use in other surgeries suggests it is generally safe for patients. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Surgiphor is unique because it uses povidone iodine, a powerful antiseptic, to wash shoulder replacement components before and after placement. This approach is different from the standard use of sterile saline, offering an added layer of infection control. Researchers are excited because povidone iodine's antimicrobial properties might reduce infection rates, potentially leading to safer surgeries and better outcomes for patients undergoing shoulder arthroplasty.

What evidence suggests that Surgiphor is effective for reducing bacteria during shoulder replacement surgery?

Research has shown that using Povidone-Iodine, such as Surgiphor, during surgeries can help reduce infections. In this trial, one arm will use Surgiphor (Povidone-Iodine) for washing during total shoulder arthroplasty. A study found that diluted povidone-iodine solutions reduced infections at the surgery site by 3.4% for spine and joint surgeries. This resulted in fewer post-surgery infections. The iodine in Povidone-Iodine kills germs by breaking down their proteins and fats, helping to keep the surgical area clean and lowering the risk of infection. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12558903/

Infection prevention strategies in shoulder surgery Postoperative antibiotics were given by 43% post-arthroscopy and 90% post-arthroplasty (96% and 95% gave first-generation cephalosporins ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05919888?term=deep-2&viewType=Table&rank=4

SURGX Antimicrobial Gel Versus Povidone-iodine Skin ... The second purpose of this study is to compare the use of standard povidone-iodine swab versus SURGX antimicrobial gel as an application into the dermal layer ...

3. wjgnet.com wjgnet.com/2218-5836/full/v16/i10/110741

Effectiveness of surgical skin preparation solutions in ... This study found that there was a significant decrease in SSI with the use of aqueous chlorhexidine for elective upper extremity surgery. It ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7661562/

Periprosthetic Infection After Reverse Shoulder Arthroplasty The purpose of this article is to review the incidence, diagnosis, prevention, and management of periprosthetic infections after reverse shoulder arthroplasty.

5. journaloei.scholasticahq.com journaloei.scholasticahq.com/article/67844-optimizing-outcomes-in-shoulder-arthroplasty-mitigating-surgical-complications-in-high-risk-patients-case-report

Optimizing Outcomes in Shoulder Arthroplasty Efficacy of dilute povidone-iodine solutions during spine and arthroplasty surgeries have shown a 3.4% reduction in SSI rate and 84.5 ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07104084

Influence of Antiseptic Washes on Wound Healing ... Study participants will be randomized into one of two groups: washing the surgical wound with povidone-iodine solution (Surgiphor, Becton Dickinson, Franklin ...

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/os.14052

Efficacy of a Novel Intraoperative Surgical Irrigant in ... This is a retrospective study of 423 primary joint arthroplasties that were performed by multiple orthopedic surgeons at a single hospital ...

8. hub.jbjs.org hub.jbjs.org/reader.php?rsuite_id=f9657197-fedc-425c-b48d-3572192f2376

Risk Factors and Prophylactic Measures for Shoulder ... Conclusions: Younger patients and patients undergoing procedures other than anatomic total shoulder arthroplasty are at higher risk for shoulder ...