Vancomycin Powder for Broken Bones

(PIVOT Trial)

Overseen By Gabriel Larose, MD, MSc, FRCSC

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Manitoba

Must not be taking: Local antibiotics

Disqualifiers: Vancomycin allergy, Infection, Bacteremia, 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: Unknown

Duration: At time of definitive surgical orthopedic fixation

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether adding vancomycin powder (an antibiotic) to the usual treatment can prevent infections after surgery for broken bones. It focuses on individuals with open fractures in the arms or legs. Participants will receive either the vancomycin powder during surgery or the standard treatment of antibiotics and cleaning. Eligible participants should have a fracture requiring surgery and be able to follow up for six months post-procedure. As a Phase 4 trial, this research aims to understand how the already FDA-approved and effective treatment can benefit more patients.

Do I need to stop my current medications for the 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 powdered intrawound vancomycin?

Research has shown that applying powdered vancomycin directly on wounds can safely help prevent infections after surgery. In one study with 980 patients, it reduced deep surgical site infections by 3.4%. Another report found that it significantly lowered infection rates, with an odds ratio of 0.41, indicating greater effectiveness than standard care alone. These studies suggest that powdered vancomycin is well-tolerated, making it a promising option for those with open fractures. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using powdered intrawound vancomycin for broken bones because it offers a new delivery method directly at the fracture site during surgery. Unlike the standard intravenous antibiotics, which circulate throughout the body, this approach allows for a high concentration of antibiotics right where they're needed, potentially reducing the risk of infection more effectively. This direct application could lead to faster recovery times and less systemic side effects, making it a promising option for patients with open fractures.

What evidence suggests that powdered intrawound vancomycin is effective for preventing post-operative infections in open fractures?

Research has shown that applying powdered vancomycin directly on wounds can help reduce infections after surgery. One study found it lowered the rate of deep infections by 3.4% in patients with open fractures. Another study demonstrated a significant reduction in infections after high-risk fractures in the knee area. This trial will compare the use of powdered intrawound vancomycin, applied during surgery, with a control group receiving only intravenous antibiotics with irrigation and debridement. Previous results suggest that applying vancomycin powder during orthopedic surgeries is a safe and effective way to prevent infections. This treatment has proven effective in reducing infections, leading to its approval for use in certain situations. ^{1 2 4 5 6}

Who Is on the Research Team?

Madison Price, MD

Principal Investigator

University of Manitoba

Gabriel Larose, MD, MSc, FRCSC

Principal Investigator

University of Manitoba

Are You a Good Fit for This Trial?

This trial is for patients with open fractures in their arms or legs. They must be undergoing surgery to fix the fracture and can receive standard IV antibiotics. People who have allergies to vancomycin, are pregnant, under 18, or have other infections that could affect results aren't eligible.

Inclusion Criteria

I have an open fracture classified as Gustilo Type I to IIIc.

I had surgery with plates, screws, or a rod for a broken bone.

I can go to follow-up appointments for 6 months after surgery.

Exclusion Criteria

Patients with known vancomycin allergy, drug administration reaction, or other sensitivities to vancomycin

Patients with open fracture already infected at time of enrollment

Patients with current positive blood cultures (bacteremia) at time of enrollment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intra-operative intrawound topical vancomycin powder in addition to intravenous antibiotics with irrigation and debridement during definitive operative fixation of the fracture

At time of definitive surgical orthopedic fixation

Follow-up

Participants are monitored for post-operative infections and hardware failure

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Powdered Intrawound Vancomycin

Trial Overview The study tests if adding powdered vancomycin directly into the wound during surgery reduces infection rates compared to just using IV antibiotics with cleaning and removal of damaged tissue.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

Powdered, intrawound vancomycin 1000 mg at the time of definitive surgery for open fracture fixation in addition to the current best practice of intravenous antibiotics with irrigation and debridement

Group II: Control Active Control 1 Intervention

Intravenous antibiotics with irrigation and debridement alone.

Who Is Running the Clinical Trial?

University of Manitoba

Lead Sponsor

Trials

628

Recruited

209,000+

Health Sciences Centre, Winnipeg, Manitoba

Collaborator

Trials

18

Recruited

11,600+

Published Research Related to This Trial

In a mouse model of spine implant infection, intrawound vancomycin powder significantly reduced bacterial loads and persistent infections compared to controls, indicating its efficacy in preventing infections during spine surgery.

The study found that while vancomycin powder is effective, it does not completely eradicate infections, and lower doses (like 2 mg) still provide protective benefits, suggesting potential for dose adjustments in certain patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Progress not panacea: vancomycin powder efficacy and dose evaluated in an in vivo mouse model of spine implant infection. Park, HY., Hegde, V., Zoller, SD., et al.[2021]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06504992

Powdered Intrawound Vancomycin in Open Fractures Trial ... The purpose of this randomized control trial is to compare the rate of post-operative infection in patients with open fractures in upper or lower extremity ...

2. jamanetwork.com jamanetwork.com/journals/jamasurgery/fullarticle/2777798

Effect of Intrawound Vancomycin Powder in Operatively ... In this randomized clinical trial of 980 patients, intrawound vancomycin reduced deep surgical site infection rates by 3.4%.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9953039/

Local administration of vancomycin powder in orthopaedic ... This study reports on the variability of prophylactic vancomycin powder use in orthopaedic trauma cases across 28 centers. Methods: Intrawound ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0020138323000955

Intrawound application of vancomycin reduces the ... Intrawound application of vancomycin was associated with a significant lower rate of FRI after high-risk tibial plateau fracture surgery compared to the ...

5. cureus.com cureus.com/articles/379021-clinical-outcomes-of-vancomycin-powder-for-surgical-site-prophylaxis-in-orthopedic-surgeries-a-comparative-study

Clinical Outcomes of Vancomycin Powder for Surgical Site ... These findings suggest that local VP can be a safe and effective prophylactic measure to reduce SSIs in orthopedic surgery.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12165581/

Intrawound vancomycin powder for prevention of surgical site ... The pooled results indicate that intrawound vancomycin significantly reduces overall infection rates [odds ratio (OR): 0.41; 95% confidence ...