1832 Participants Needed

Antibiotics in Joint Replacement for Preventing Infections

KT
BB
Overseen ByBenoit Benoit, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 4 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to compare infection rates when patients, elected for primary or aseptic revision THA / TKA, have a single intravenous antibiotic dose versus one single intravenous antibiotic dose in combination with intra-articular antibiotics. This is a prospective, randomized clinical survey on selected outcome measurements on 1834 subjects who will be recruited in a period of about 2 years.

Will I have to stop taking my current medications?

The trial information 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.

Is vancomycin powder safe for use in joint replacement surgeries?

Vancomycin powder has been shown to be safe in reducing infections after surgeries, such as spine surgeries, and studies suggest it may also be safe for use in joint replacement surgeries to prevent infections.12345

How is the drug Intra-articular Vancomycin Powder different from other treatments for preventing infections in joint replacement?

Intra-articular Vancomycin Powder is unique because it is applied directly into the surgical wound during joint replacement, which may help reduce the risk of infection more effectively than standard systemic antibiotics alone. This direct application targets the area most at risk for infection, potentially offering a more focused approach to preventing infections in joint replacements.12456

What data supports the effectiveness of the drug Intra-articular Vancomycin Powder in preventing infections in joint replacement surgeries?

Research shows that using vancomycin powder directly in the surgical wound during joint replacement can significantly reduce early joint infections, especially in revision surgeries, compared to standard antibiotic treatments.12347

Who Is on the Research Team?

BB

Benoit Benoit, MD

Principal Investigator

CIUSSS du Nord de l'Île de Montreal

Are You a Good Fit for This Trial?

Adults over 18 needing a new hip or knee joint (arthroplasty) due to osteoarthritis, bone death, arthritis, or previous joint replacement issues can join. They must be in good health for surgery and able to follow up for 2 years. People with skin diseases, infections, vancomycin allergies, or enrolled in other trials cannot participate.

Inclusion Criteria

Subject is willing to consent to participate in the study
I am having a revision of my hip or knee replacement due to non-infection reasons.
I meet the requirements for a first-time hip or knee replacement.
See 4 more

Exclusion Criteria

I do not have any ongoing infections.
I have a skin condition.
I am unable to give consent by myself.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of IV cefazolin and, for some, an additional intra-articular vancomycin powder during knee or hip arthroplasty

Surgery day
1 visit (in-person)

Follow-up

Participants are monitored for infection rates and other outcomes after surgery

3 months
Multiple visits (in-person and virtual)

Long-term Follow-up

Participants are monitored for long-term infection rates and other outcomes

2 years

What Are the Treatments Tested in This Trial?

Interventions

  • Intra-articular Vancomycin Powder
Trial Overview This study is testing if adding intra-articular antibiotics to the usual single IV antibiotic dose lowers infection rates after hip/knee replacements. It's a randomized trial involving 1834 patients who will be observed for outcomes over about two years.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: VancoExperimental Treatment1 Intervention
Patients receiving a single dose of IV cefazolin (2 grams if \< 120kg; 3 grams if \>120kg) 10-60 minutes before incision + a single dose of intra-articular vancomycin powder (1 gram) before articulation (hip or knee) closure
Group II: StandardActive Control1 Intervention
Patients receiving single dose of IV cefazolin (2 grams if \< 120kg; 3 grams if \>120kg) 10-60 minutes before incision

Intra-articular Vancomycin Powder is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸
Approved in United States as Vancomycin for:
  • Severe bacterial infections
  • MRSA infections
  • Clostridium difficile-associated diarrhea and enterocolitis
🇪🇺
Approved in European Union as Vancomycin for:
  • Severe bacterial infections
  • MRSA infections
  • Endocarditis
  • Peritonitis
🇨🇦
Approved in Canada as Vancomycin for:
  • Severe bacterial infections
  • MRSA infections
  • Clostridium difficile-associated diarrhea and enterocolitis
🇯🇵
Approved in Japan as Vancomycin for:
  • Severe bacterial infections
  • MRSA infections

Find a Clinic Near You

Who Is Running the Clinical Trial?

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

Lead Sponsor

Trials
17
Recruited
4,600+

Published Research Related to This Trial

The use of intrawound vancomycin powder during joint arthroplasty significantly reduced the overall rate of early prosthetic joint infections (PJI) from 1.57% in the control group to 0.49% in the treatment group, based on a study of 1640 patients over two years.
Specifically, in revision arthroplasty procedures, the vancomycin group showed a notable decrease in early PJIs from 3.89% to 0%, indicating that intrawound vancomycin may be particularly effective in this subgroup.
Intrawound Vancomycin Powder Reduces Early Prosthetic Joint Infections in Revision Hip and Knee Arthroplasty.Otte, JE., Politi, JR., Chambers, B., et al.[2022]
In a study of 98 patients undergoing total knee arthroplasty, the use of intraoperative vancomycin powder did not significantly reduce the risk of surgical site infections compared to a control group.
The results suggest that vancomycin powder may not be an effective intervention for preventing infections in primary total knee arthroplasty, as indicated by a p-value of 0.31.
The efficacy of vancomycin powder in total knee arthroplasty: A single-center study.Aljuhani, WS., Alanazi, AM., Alghafees, MA., et al.[2022]
In a randomized controlled trial involving 165 patients undergoing total knee arthroplasty, the use of intrawound vancomycin powder was found to be less effective than standard postoperative intravenous antibiotics in preventing periprosthetic joint infections (PJIs).
The trial was stopped early after one year due to a significantly higher incidence of PJIs in the vancomycin group (3.75%) compared to the control group (0%), indicating that intrawound vancomycin may not be a safe alternative to standard antibiotic protocols.
Is Topical Vancomycin an Option? A Randomized Controlled Trial to Determine the Safety of the Topical Use of Vancomycin Powder in Preventing Postoperative Infections in Total Knee Arthroplasty, as Compared With Standard Postoperative Antibiotics.Abuzaiter, W., Bolton, CA., Drakos, A., et al.[2023]

Citations

Intrawound Vancomycin Powder Reduces Early Prosthetic Joint Infections in Revision Hip and Knee Arthroplasty. [2022]
The efficacy of vancomycin powder in total knee arthroplasty: A single-center study. [2022]
Is Topical Vancomycin an Option? A Randomized Controlled Trial to Determine the Safety of the Topical Use of Vancomycin Powder in Preventing Postoperative Infections in Total Knee Arthroplasty, as Compared With Standard Postoperative Antibiotics. [2023]
Intra-Articular Vancomycin Powder Eliminates Methicillin-Resistant S. aureus in a Rat Model of a Contaminated Intra-Articular Implant. [2022]
Can Topical Vancomycin Prevent Periprosthetic Joint Infection in Hip and Knee Arthroplasty? A Systematic Review. [2023]
Serum and Synovial Vancomycin Concentrations in Patients with Prosthetic Joint Infection after Intra-articular Infusion. [2022]
Intrawound vancomycin in primary hip and knee arthroplasty: a safe and cost-effective means to decrease early periprosthetic joint infection. [2022]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security