Antimicrobial Wash for Shoulder Replacement Surgery

Overseen By Jared Mahylis, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Henry Ford Health System

Disqualifiers: Cancer, Autoimmune disorders, others

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

Compensation: Varies

Number of Visits: 6

Duration: Surgery day

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if washing with different antimicrobial solutions after shoulder replacement surgery can reduce the presence of C. acnes, a type of bacteria. Participants will be randomly assigned to one of four groups: Xperience Antimicrobial Wash (a specialized cleansing solution), 3% hydrogen peroxide, 10% povidone-iodine (betadine), or no treatment after incision. Individuals scheduled for primary shoulder replacement due to severe shoulder arthritis, who have tried other treatments for at least six weeks without success, might be suitable candidates. As an unphased trial, this study allows participants to contribute to valuable research that could enhance post-surgical outcomes for future 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. However, since the trial involves shoulder surgery, it's best to discuss your medications with the trial team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that using hydrogen peroxide on the skin before shoulder surgery is safe. Research suggests it might even reduce the likelihood of needing additional surgeries later. Povidone-iodine, another treatment, has also demonstrated good results in reducing infections during surgeries. It is often used in a diluted form to help prevent infections.

For the Xperience Antimicrobial Wash, research indicates it has effectively prevented infections during surgery, with one study reporting no infections within 90 days post-surgery. This suggests it is well-tolerated and safe to use.

All these treatments have been studied for their safety and effectiveness in surgical settings, showing they are generally well-tolerated and can help reduce the risk of infections. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for shoulder replacement surgery because they offer new ways to reduce bacterial infections. Unlike the standard care that often relies on antibiotics, the 10% Povidone-Iodine and 3% Hydrogen Peroxide treatments work by using powerful antiseptic properties applied directly to the skin. The Xperience Antimicrobial Wash is particularly interesting because it combines citric acid, sodium citrate, and sodium lauryl sulfate to create a unique antimicrobial environment on the skin. These approaches could potentially lower infection rates more effectively than current methods, which is a big win for surgical outcomes.

What evidence suggests that this trial's treatments could be effective for reducing C. acnes in shoulder replacement surgery?

Research has shown that using 3% hydrogen peroxide, one of the treatments in this trial, effectively reduces Cutibacterium acnes during shoulder surgeries, potentially lowering infection risk and the need for additional surgeries. Another treatment option, Povidone-iodine, a common surgical antiseptic, has reduced infection rates by about 3.4%. Xperience Antimicrobial Wash, also tested in this trial, is a newer option, and early research suggests it might help prevent infections after joint surgeries. All these treatments aim to reduce bacteria, which is key to preventing infections after shoulder replacement surgery. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for adults undergoing primary shoulder replacement surgery. The study aims to see if washing the surgical site with different antimicrobial solutions after making an incision can reduce bacteria levels.

Inclusion Criteria

Ability to read and understand English

I am scheduled for a first-time shoulder replacement surgery.

I've tried NSAIDs for over 6 weeks without improvement.

Exclusion Criteria

I have cancer.

History of allergic reaction to citric acid-derived products

I have had an infection in my shoulder joint before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Post-incision application of antimicrobial solutions or no treatment during shoulder arthroplasty

Surgery day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including wound healing and complications

1 year

5 visits (in-person) at 2 weeks, 6 weeks, 3 months, 6 months, and 1 year

What Are the Treatments Tested in This Trial?

Interventions

• 10% Povidone-Iodine
• 3% Hydrogen Peroxide
• Xperience Antimicrobial Wash

Trial Overview

Participants will be randomly assigned to one of four groups: those receiving a post-incision wash with Xperience Antimicrobial, hydrogen peroxide, povidone-iodine, or no treatment (control). The goal is to compare the effectiveness in reducing P. Acnes bacteria.

How Is the Trial Designed?

Group I: Xperience Antimicrobial Wash Experimental Treatment 3 Interventions

Xperience Antimicrobial Wash is composed of 32.5 g/L citric acid, 31.3 g/L sodium citrate, and 1.00 g/L sodium lauryl sulfate in sterile water. It is to be applied along the entire dermis using a soaked surgical sponge following initial incision.

Group II: 3% hydrogen peroxide Experimental Treatment 3 Interventions

To be applied along the entire dermis using a soaked surgical sponge following initial incision.

Group III: 10% povidone-iodine Experimental Treatment 3 Interventions

To be applied along the entire dermis using a soaked surgical sponge following initial incision.

Group IV: Control Active Control 2 Interventions

No treatment of the dermal layer will be performed prior to a collection of the bacterial cultures

Who Is Running the Clinical Trial?

Henry Ford Health System

Lead Sponsor

Trials

334

Recruited

2,197,000+

Next Science TM

Industry Sponsor

Trials

17

Recruited

9,700+

Published Research Related to This Trial

Chlorhexidine at concentrations of 0.05% and 0.1% effectively eradicated Staphylococcus epidermidis biofilms in vitro when exposed for clinically relevant times (1, 5, and 10 minutes).

Povidone-iodine at 0.35% and 1.0% concentrations, as well as sodium hypochlorite and triple antibacterial solutions, were ineffective against biofilms, suggesting chlorhexidine may be a superior choice for intraoperative irrigation in preventing infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chlorhexidine Antiseptic Irrigation Eradicates Staphylococcus epidermidis From Biofilm: An In Vitro Study. Schmidt, K., Estes, C., McLaren, A., et al.[2020]

In a study of 475 pediatric patients undergoing spinal surgery, the combination of 3.5% Povidone-iodine irrigation and intrawound Vancomycin powder significantly reduced the surgical site infection (SSI) rate to 0.7%, compared to 10% in patients receiving no intervention.

The use of Vancomycin powder alone also showed a lower infection rate of 1.4%, indicating that both treatments are effective, but the combination offers the best protection against infections in non-neuromuscular patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Povidone-iodine irrigation combined with Vancomycin powder lowers infection rates in pediatric deformity surgery. Roberto, RF., Rowan, FA., Nallur, D., et al.[2022]

In a study of 66 patients undergoing shoulder arthroplasty, pre-operative chlorhexidine showers effectively reduced the skin load of various bacterial species, but did not significantly decrease the load of Cutibacterium, which is a major contributor to shoulder infections.

The findings suggest that while chlorhexidine showers can help lower some bacterial counts, they are not effective against Cutibacterium, indicating a need for alternative methods to better manage this specific bacteria before surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

While home chlorhexidine washes prior to shoulder surgery lower skin loads of most bacteria, they are not effective against Cutibacterium (Propionibacterium). Matsen, FA., Whitson, AJ., Hsu, JE.[2021]

In a study of 100 patients undergoing shoulder surgery, using 2% chlorhexidine gluconate cloths before surgery significantly reduced the rate of pathogenic bacteria on the skin compared to standard soap and water, with positive culture rates of 66% versus 94%.

The chlorhexidine cloths were particularly effective against coagulase-negative Staphylococcus, which is a common cause of postoperative infections, suggesting that this method could enhance infection prevention strategies without leading to any infections in the two-month follow-up period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of preoperative home use of 2% chlorhexidine gluconate cloth before shoulder surgery. Murray, MR., Saltzman, MD., Gryzlo, SM., et al.[2022]

In a study involving 50 male patients undergoing shoulder arthroplasty, both chlorhexidine washes and benzoyl peroxide soap were ineffective in reducing Cutibacterium levels on the skin surface and in the dermis, with 100% positivity in both groups.

The bacterial load measured on the skin surface and the incised dermal edge was similar for both treatments, indicating that neither method significantly impacted the presence of Cutibacterium before surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of chlorhexidine wash versus benzoyl peroxide soap for home surgical preparation: neither is effective in removing Cutibacterium from the skin of shoulder arthroplasty patients. Hsu, JE., Whitson, AJ., Woodhead, BM., et al.[2021]

In a study of 3232 patients undergoing total hip or knee arthroplasty, the use of dilute Betadine irrigation prior to wound closure significantly reduced the overall infection rate and the rate of surgical site infections (SSI) compared to normal saline, with odds ratios of 0.45 and 0.30 respectively.

While Betadine irrigation was effective in reducing general infections and SSIs, it did not show a significant impact on deep infections, indicating that while it is a beneficial practice, it may not eliminate all risks associated with periprosthetic joint infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Povidone-iodine irrigation reduces infection after total hip and knee arthroplasty. Muwanis, M., Barimani, B., Luo, L., et al.[2023]

A study involving 244 patients undergoing spinal surgery found that using diluted povidone-iodine solution for wound irrigation significantly reduced the infection rate compared to normal saline, with no infections reported in the povidone-iodine group.

The use of diluted povidone-iodine did not negatively affect wound healing, bone fusion, or clinical outcomes, indicating it is a safe option for disinfection in spinal surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can povidone-iodine solution be used safely in a spinal surgery? Chang, FY., Chang, MC., Wang, ST., et al.[2022]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10210324/

How effective is diluted povidone-iodine in preventing ...

PI irrigation seems an efficient preventive measure for post-operative PJI and would seem to be the most feasible for TJA protocol.

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S1058274625002769

The toxicity of chlorhexidine and povidone-iodine to rotator ...

Brief 0.05% CHG and 0.35% PI exposures to rotator cuff tendon may lead to reduced tenocyte viability, with the tendinous portion seemingly more susceptible ...

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clinicaltrials.gov/study/NCT06831422?cond=%22Acne%22&intr=%22Plasma%20Substitutes%22&viewType=Table&rank=1

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The purpose of this randomized controlled trial is to determine the effect of post-incision wash using various novel antimicrobial solutions on the rate of ...

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withpower.com

withpower.com/trial/antimicrobial-wash-for-shoulder-replacement-surgery-ca36e

Antimicrobial Wash for Shoulder Replacement Surgery

Research shows that using a solution of povidone-iodine and hydrogen peroxide can effectively reduce post-operative infections in spine surgeries, suggesting it ...

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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 ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10382412/

Preventing and Treating Infection in Reverse Total ...

Use of povidone-iodine solution lavage has also shown promising results of reduction in skin and soft tissue infections in the spine literature ...

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sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0883540319301986

Infection The Cost Effectiveness of Dilute Betadine Lavage ...

This break-even analysis demonstrates that dilute Betadine lavage can be highly cost effective for preventing PJI following TJA.

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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 ...

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Dilute Povidone-Iodine Irrigation: The Science of Molecular ...

Clinical studies have verified notable reductions in surgical site infections with a 3-minute soak of 0.35% dilute povidone-iodine irrigation.

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12155827/

Advances in Orthopedic Surgery Irrigation: A Review of ...

Preliminary clinical studies have demonstrated reduced infection rates, improved early postoperative recovery, and favorable outcomes in both ...