Antibiotics in Joint Replacement for Preventing Infections

Not currently recruiting at 1 trial location

Overseen By Benoit 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

Disqualifiers: Active infection, Allergy to vancomycin, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Surgery day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if using two types of antibiotics can better prevent infections after hip or knee replacement surgeries. Participants will receive either a standard dose of antibiotics through an IV or that dose combined with an antibiotic powder (intra-articular Vancomycin) applied directly to the joint. The trial seeks individuals undergoing their first hip or knee replacement or those having a redo surgery without infection, who have conditions like arthritis or osteonecrosis. Participants should be able to follow up for two years and be fluent in English or French. As an unphased trial, this study offers participants the chance to contribute to important research that could enhance surgical outcomes for future patients.

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

Research has shown that using vancomycin powder in joint surgeries is generally safe for patients. Studies have found that applying this powder in the joint area can help reduce the risk of infections after surgery.

For example, one study tested different amounts of the powder, ranging from 88 to 176 mg/kg, and found it safe and effective in preventing infections from certain bacteria. Another study demonstrated that using vancomycin powder directly on the wound during hip and knee surgeries was both safe and cost-effective.

While the safety data is encouraging, it's important to remember that each body can react differently. Always consult a doctor about any concerns before deciding to join a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using intra-articular vancomycin powder in joint replacement surgeries because it offers a new way to prevent infections. Unlike traditional methods that rely solely on intravenous antibiotics like cefazolin, this approach involves directly applying vancomycin powder to the joint before closing the incision. This localized delivery method allows for a concentrated dose of antibiotics right at the site where infections are most likely to occur, potentially increasing effectiveness while minimizing systemic side effects. By targeting the joint directly, this method could provide enhanced protection against infections, a common complication in joint replacement surgeries.

What evidence suggests that intra-articular vancomycin powder is effective for preventing infections in joint replacement surgeries?

In this trial, participants will be divided into two groups to evaluate the effectiveness of vancomycin powder in preventing infections after joint replacement surgery. Research has shown that applying vancomycin powder directly in the joint can help prevent infections. One study found that a single dose of this powder significantly reduced serious joint infections. Another study demonstrated its effectiveness against infections caused by MRSA, a difficult-to-treat bacteria. A review of 21 studies confirmed that using vancomycin powder lowered the risk of deep wound infections in joint surgeries. These findings suggest that vancomycin powder can be a useful part of infection prevention in joint replacement procedures. ^{1 6 7 8 9}

Who Is on the Research Team?

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.

Exclusion Criteria

I do not have any ongoing infections.

I have a skin condition.

I am unable to give consent by myself.

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?

Group I: Vanco Experimental Treatment 1 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: Standard Active Control 1 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

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

Topical vancomycin (vancomycin powder) did not show a significant reduction in the risk of periprosthetic joint infection (PJI) after hip and knee arthroplasty, with only one out of nine studies indicating any benefit.

There was no increase in overall complication risks associated with the use of topical vancomycin compared to standard infection prevention methods, but the studies were underpowered to detect rare complications, suggesting that more robust research is needed before routine use can be recommended.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can Topical Vancomycin Prevent Periprosthetic Joint Infection in Hip and Knee Arthroplasty? A Systematic Review. Wong, MT., Sridharan, SS., Davison, EM., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of vancomycin powder in total knee arthroplasty: A single-center study. Aljuhani, WS., Alanazi, AM., Alghafees, MA., et al.[2022]

In a study involving 32 rats with contaminated knee implants, the combination of intra-articular vancomycin powder and systemic vancomycin completely eliminated methicillin-resistant Staphylococcus aureus (MRSA) contamination, while systemic vancomycin alone did not.

No adverse effects or toxicity were observed in any treatment group, indicating that the use of intra-articular vancomycin powder is safe and warrants further investigation in clinical settings to prevent periprosthetic joint infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intra-Articular Vancomycin Powder Eliminates Methicillin-Resistant S. aureus in a Rat Model of a Contaminated Intra-Articular Implant. Edelstein, AI., Weiner, JA., Cook, RW., et al.[2022]

In a study of 460 total hip and knee arthroplasties, the use of intrawound vancomycin significantly reduced the overall infection rate from 2.7% to 0.57% and the periprosthetic joint infection (PJI) rate from 2.7% to 0.29%.

The addition of intrawound vancomycin did not increase the risk of ototoxicity or acute kidney injury, suggesting it is a safe option for reducing infection rates in arthroplasty surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intrawound vancomycin in primary hip and knee arthroplasty: a safe and cost-effective means to decrease early periprosthetic joint infection. Patel, NN., Guild, GN., Kumar, AR.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 16 patients with prosthetic joint infection (PJI), intra-articular (IA) infusion of vancomycin at 0.5 g daily effectively maintained high concentrations of the drug in the synovial fluid, which is crucial for treating infections in the joint area.

Combining IA vancomycin with intravenous (IV) administration resulted in good trough concentrations in both serum and synovial fluid, although IV vancomycin alone did not achieve detectable levels in the synovial fluid, highlighting the importance of IA infusion for effective treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serum and Synovial Vancomycin Concentrations in Patients with Prosthetic Joint Infection after Intra-articular Infusion. He, JW., Wang, J., Cao, L., 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39872993/

Effectiveness of intra-articular vancomycin in preventing ... This study aimed to evaluate the effectiveness and safety of intra-articular vancomycin powder in reducing prosthetic joint infections (PJIs) in primary hip ...

2. journals.asm.org journals.asm.org/doi/10.1128/AAC.01641-21

Dosage, Efficacy, and Safety of Intra-articular Vancomycin for ... Intra-articular vancomycin powder at a dosage from 88 mg/kg to 176 mg/kg may be effective and safe in preventing PJI induced by methicillin-resistant S. aureus ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38419970/

Intra-articular Vancomycin Reduces Prosthetic Infection in ... A single dose of intra-articular vancomycin 1 gm injected into the total joint replacement following fascial closure reduced the incidence of deep PJI ...

4. bmcmicrobiol.biomedcentral.com bmcmicrobiol.biomedcentral.com/articles/10.1186/s12866-021-02399-5

Intra-wound vancomycin powder for the eradication of ... This study aimed to explore the efficacy and safety of intra-wound VP in the control of methicillin-resistant S. aureus (MRSA) infection after debridement and ...

5. mdpi.com mdpi.com/2079-6382/14/3/214

Effectiveness of Local Antibiotics for Infection Prevention in ... Our meta-analysis of 21 articles demonstrated that vancomycin powder effectively reduced the risk of deep wound infections or PJI in primary joint arthroplasty, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8846311/

Dosage, Efficacy, and Safety of Intra-articular Vancomycin ... Intra-articular vancomycin powder at a dosage from 88 mg/kg to 176 mg/kg may be effective and safe in preventing PJI induced by methicillin-resistant S. aureus ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06889701

NCT06889701 | A Phase 1/2 Study to Evaluate the Safety, ... This is a Phase 1/2, randomized, controlled, open-label, proof-of-concept study to evaluate the safety and tolerability, local and systemic PK profiles of ...

8. journals.asm.org journals.asm.org/doi/10.1128/aac.00303-21

Local Application of Vancomycin in One-Stage Revision of ... Periprosthetic joint infection (PJI) is one of the catastrophic complications after artificial joint replacement and occurs in 1.2% to 2.2% of ...

9. josr-online.biomedcentral.com josr-online.biomedcentral.com/articles/10.1186/s13018-022-03445-2

Effects of different doses of vancomycin powder in total knee ... Intrawound vancomycin in primary hip and knee arthroplasty: a safe and cost-effective means to decrease early periprosthetic joint infection.