IO vs IV Vancomycin for Preventing Infection in Shoulder Surgery

Overseen By Haley Goble, MHA

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: The Methodist Hospital Research Institute

Disqualifiers: Previous shoulder surgery, BMI above 35, diabetes, immunocompromised, others

Prior Safety Data This treatment has passed at least one previous human trial

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

Compensation: Varies

Number of Visits: 2

40 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to compare two different antibiotic regimens and techniques during total shoulder arthroplasty. Primary Objective: Comparable levels of vancomycin will be found in bone, soft tissue, and systemic samples between patient groups. Secondary Objective: Compare 30 day and 90 day post-operative complication rates (infection) between the control (standard IV administration of vancomycin) vs the interventional group (intraosseous administration of vancomycin). The investigators hypothesize that there will be no difference in complication (infection) rates between groups.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are taking medications that affect your immune system, you may not be eligible to participate.

What data supports the effectiveness of the drug vancomycin in preventing infection in shoulder surgery?

Research suggests that vancomycin, when used as a preventive measure in surgeries like shoulder arthroplasty, can help reduce infections, especially when there is a risk of resistant bacteria. Intraosseous (IO) administration of vancomycin has shown to provide better local antibiotic concentration compared to intravenous (IV) methods in similar surgeries, like total knee arthroplasty, which may imply potential benefits for shoulder surgeries as well. ^{1 2 3 4 5}

Is vancomycin safe for use in surgeries?

Vancomycin is generally safe for use in surgeries, but it requires careful administration to avoid side effects. For example, intravenous vancomycin needs to be given slowly to prevent complications, and intraosseous vancomycin has been used safely in knee surgeries. ^{1 2 3 6 7}

How does the drug vancomycin differ in preventing infections in shoulder surgery?

The use of intraosseous (IO) vancomycin in shoulder surgery is unique because it can provide higher local tissue concentrations compared to the traditional intravenous (IV) method, potentially leading to better infection prevention. ^{1 2 3 6 8}

Eligibility Criteria

This trial is for adults over 18 who are having shoulder replacement surgery and can consent to the study. It's not for those with past shoulder surgeries, allergies to certain antibiotics like vancomycin, or conditions that make IO infusion impossible. People with diabetes, weakened immune systems, or a BMI above 35 are also excluded.

Inclusion Criteria

I am having shoulder replacement surgery.

Patient is able to give informed consent to participate in the study. LAR consents will not be utilized for this study

I am older than 18 years.

Exclusion Criteria

I have a weakened immune system due to a condition or treatment.

I have had shoulder surgery before.

My BMI is over 35.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative

Participants receive pre-operative antibiotic regimen including IV antibiotics approximately 1 hour prior to incision

1 day

1 visit (in-person)

Intra-operative

Participants undergo total shoulder arthroplasty with either IV or IO vancomycin administration; intra-operative sample collection occurs

1 day

1 visit (in-person)

Post-operative Monitoring

Participants are monitored for adverse reactions and vancomycin levels are measured

24 hours

Follow-up

Participants are monitored for post-operative complications and infection rates at 30 and 90 days

90 days

Treatment Details

Interventions

• Vancomycin

Trial Overview The study compares two ways of giving the antibiotic vancomycin during shoulder surgery: through IV (control) and directly into the bone (IO). The goal is to see if both methods deliver similar drug levels in tissues and have comparable infection rates after surgery at 30 and 90 days.

Participant Groups

Group I: Intervention - Intraosseous (IO) administration of vancomycin Experimental Treatment 1 Intervention

* IV antibiotics (per physician's standard of care): Typically ancef or cefepime is started in pre-op within 1 hour of incision * IO vancomycin is administered in the OR after sterile prep and draping has occurred (500mg in 100-150mL NS). * Injection will take place into the proximal humerus

Group II: Control - Standard IV administration of vancomycin Placebo Group 1 Intervention

Patients will receive the Houston Methodist Hospital orthopedic surgeon's standard of care pre-operative antibiotic regimen for primary total shoulder arthroplasty patients. This includes IV abx (typically ancef or cefepime and vancomycin) will be started in the pre-operative period approximately 1 hour prior to incision (vancomycin dose weight-based at approximately 15mg/kg \[6,7\] generally 1000-1750mg in 500mL NS).

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

Approved in United States as Vancocin for:

• Severe infections caused by susceptible strains of methicillin-resistant staphylococci
• Enterocolitis caused by Staphylococcus aureus
• Staphylococcal endocarditis

Approved in European Union as Vancomycin for:

• Severe infections caused by Gram-positive bacteria
• Endocarditis
• Peritonitis associated with continuous ambulatory peritoneal dialysis (CAPD)

Approved in Canada as Vancomycin for:

• Severe infections caused by susceptible strains of methicillin-resistant staphylococci
• Enterocolitis caused by Staphylococcus aureus

Approved in Japan as Vancomycin for:

• Severe infections caused by Gram-positive bacteria
• Endocarditis

Who Is Running the Clinical Trial?

The Methodist Hospital Research Institute

Lead Sponsor

Trials

299

Recruited

82,500+

References

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

When intravenous vancomycin prophylaxis is needed in shoulder arthroplasty, incomplete administration is associated with increased infectious complications. [2023]

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

Clinical outcome evaluation of intraosseous vancomycin in total knee arthroplasty. [2022]

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

Vancomycin is effective in preventing Cutibacterium acnes growth in a mimetic shoulder arthroplasty. [2021]

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

Oral and IV Antibiotic Administration After Single-Stage Revision Shoulder Arthroplasty: Study of Survivorship and Patient-Reported Outcomes in Patients without Clear Preoperative or Intraoperative Infection. [2022]

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

Intraoperative Intra-articular Antibiotic Injection Reduces Infection in Shoulder Arthroplasty. [2023]

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

The effect of topical povidone-iodine, intraocular vancomycin, or both on aqueous humor cultures at the time of cataract surgery. [2019]

7. England pubmed.ncbi.nlm.nih.gov

An intraoperative irrigation regimen to reduce the surgical site infection rate following adolescent idiopathic scoliosis surgery. [2022]

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

Otto Aufranc Award: Intraosseous Vancomycin in Total Hip Arthroplasty - Superior Tissue Concentrations and Improved Efficiency. [2023]