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

350 Participants Needed

Trial Summary

What is the purpose of this 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 long bones randomized to receive intra-operative intrawound topical vancomycin powder on their open fractures in addition to the current best practice of intravenous antibiotics with irrigation and debridement compared to intravenous antibiotics with irrigation and debridement alone during definitive operative fixation of the fracture.

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 data supports the effectiveness of the drug vancomycin powder for treating broken bones?

Research shows that using vancomycin powder directly in surgical wounds can reduce infections after surgeries, like spine and joint surgeries. This suggests it might also help prevent infections in broken bones. ^{1 2 3 4 5}

Is vancomycin powder safe for use in surgeries?

Intrawound vancomycin powder has been used in surgeries like spine and joint procedures, showing a reduction in infections with no significant safety concerns reported in the studies available. ^{1 2 3 5 6}

How is the drug vancomycin powder unique for treating broken bones?

Vancomycin powder is unique because it is applied directly to the surgical wound, which helps reduce infections at the site of surgery, unlike traditional antibiotics that are usually given through the bloodstream. This method has been shown to be effective in reducing infections in surgeries like spinal fusions and joint replacements. ^{1 2 3 5 7}

Research Team

Gabriel Larose, MD, MSc, FRCSC

Principal Investigator

University of Manitoba

Madison Price, MD

Principal Investigator

University of Manitoba

Eligibility Criteria

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

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. France pubmed.ncbi.nlm.nih.gov

Topical intrawound application of vancomycin powder in addition to intravenous administration of antibiotics: A meta-analysis on the deep infection after spinal surgeries. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Negligible Systemic Uptake of Suprafascial Vancomycin Powder Following Instrumented Posterior Spinal Fusion-Preliminary Results From A Randomized Clinical Trial (VANCO Trial). [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Progress not panacea: vancomycin powder efficacy and dose evaluated in an in vivo mouse model of spine implant infection. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Intrawound vancomycin application after spinal surgery: a propensity score-matched cohort analysis. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Intrawound Vancomycin Powder Reduces Early Prosthetic Joint Infections in Revision Hip and Knee Arthroplasty. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of intrawound vancomycin in primary hip and knee arthroplasty. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

The Use of Vancomycin Powder for Surgical Prophylaxis Following Craniotomy. [2018]