150 Participants Needed

Antimicrobial Wash for Shoulder Replacement Surgery

CO
JM
Overseen ByJared Mahylis, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Henry Ford Health System
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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.

What data supports the effectiveness of the treatment 10% Povidone-Iodine, 3% Hydrogen Peroxide, Xperience 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 may also help prevent infections in shoulder replacement surgeries.12345

Is the antimicrobial wash safe for use in surgeries?

Povidone-iodine, a key ingredient in the antimicrobial wash, has been used in surgeries to reduce infections, but its safety has been questioned due to occasional negative effects on wound healing and bone union. However, studies have shown it can effectively reduce post-operative infections when used in diluted form, suggesting it is generally safe when used properly.12467

How does the antimicrobial wash treatment for shoulder replacement surgery differ from other treatments?

The antimicrobial wash for shoulder replacement surgery is unique because it involves using antiseptic solutions like chlorhexidine, which are intended to reduce bacterial load on the skin before surgery. However, studies suggest that while chlorhexidine is commonly used, it may not be effective against certain bacteria like Cutibacterium, which are often found on the skin of shoulder surgery patients.238910

What is the purpose of this trial?

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 positive C. Acnes cultures collected from adults undergoing primary shoulder replacement surgery. Subjects will be randomly assigned in a 1:1:1:1 fashion to groups that will receive one of the following treatments:* Post-incision application of Xperience Antimicrobial wash (NextScience, Jacksonville, FL)* Post-incision application of 3% hydrogen peroxide* Post-incision application of 10% povidone-iodine (betadine)* No post-incision treatment (control)The investigators hypothesize that the subjects treated with the antimicrobial solutions after initial incision will have lower rates of positive C. Acnes cultures. The investigators also hypothesize that post-incision application of Xperience Antimicrobial wash and Betadine will have an equal reduction in the incidence of C. acnes as Hydrogen Peroxide.

Eligibility Criteria

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.
See 1 more

Exclusion Criteria

I have cancer.
History of allergic reaction to citric acid-derived products
I have had an infection in my shoulder joint before.
See 4 more

Timeline

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

Treatment Details

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.
Participant Groups
4Treatment groups
Experimental Treatment
Active Control
Group I: Xperience Antimicrobial WashExperimental Treatment3 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 peroxideExperimental Treatment3 Interventions
To be applied along the entire dermis using a soaked surgical sponge following initial incision.
Group III: 10% povidone-iodineExperimental Treatment3 Interventions
To be applied along the entire dermis using a soaked surgical sponge following initial incision.
Group IV: ControlActive Control2 Interventions
No treatment of the dermal layer will be performed prior to a collection of the bacterial cultures

Find a Clinic Near You

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+

Findings from Research

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

References

Prevention of post-operative infection in spine surgery by wound irrigation with a solution of povidone-iodine and hydrogen peroxide. [2017]
Chlorhexidine Antiseptic Irrigation Eradicates Staphylococcus epidermidis From Biofilm: An In Vitro Study. [2020]
Povidone-iodine irrigation combined with Vancomycin powder lowers infection rates in pediatric deformity surgery. [2022]
Povidone-iodine irrigation reduces infection after total hip and knee arthroplasty. [2023]
Meta-analysis of the efficacy of preoperative skin preparation with alcoholic chlorhexidine compared to povidone iodine in orthopedic surgery. [2021]
Can povidone-iodine solution be used safely in a spinal surgery? [2022]
Iodine-lithium-alpha-dextrin (ILαD) against Staphylococcus aureus skin infections: a comparative study of in-vitro bactericidal activity and cytotoxicity between ILαD and povidone-iodine. [2018]
While home chlorhexidine washes prior to shoulder surgery lower skin loads of most bacteria, they are not effective against Cutibacterium (Propionibacterium). [2021]
Efficacy of preoperative home use of 2% chlorhexidine gluconate cloth before shoulder surgery. [2022]
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. [2021]
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