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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two methods of using the antibiotic vancomycin to prevent infections during shoulder replacement surgery. One group receives vancomycin through an IV, the standard method. The other group receives it directly into the bone (intraosseous method), which might enhance its effectiveness. The trial aims to determine if both methods yield similar results in preventing infections. It suits individuals undergoing shoulder replacement surgery who have not had prior shoulder surgery and do not have diabetes or certain other health conditions. As a Phase 4 trial, this research involves an FDA-approved treatment and seeks to understand its benefits for a broader patient population.

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 is the safety track record for these treatments?

Research has shown that administering vancomycin directly into the bone (intraosseous or IO method) is safe and effective for preventing infections during shoulder surgeries. The IO method delivers the drug straight into the bone, achieving similar levels in the body as the traditional intravenous (IV) method. This suggests it should be equally effective at fighting infections. Importantly, studies highlight that IO vancomycin is generally well-tolerated, with most patients not experiencing major side effects.

The IV method of administering vancomycin is also commonly used and is generally safe when performed correctly. It is widely trusted in surgeries, including those on the shoulder. However, using the correct dose is crucial to avoid possible side effects.

Previous studies have shown both methods to be safe, indicating they are good options for preventing infections in shoulder surgeries. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard of care, which typically involves intravenous (IV) administration of antibiotics like vancomycin, this trial explores intraosseous (IO) administration as an innovative approach. This method involves injecting vancomycin directly into the bone (specifically, the proximal humerus), which could potentially deliver the drug more effectively to the surgical site. Researchers are excited about this technique because it might enhance antibiotic delivery, possibly reducing infection rates in shoulder surgeries more effectively than traditional methods.

What evidence suggests that this trial's treatments could be effective for preventing infection in shoulder surgery?

This trial will compare two methods of administering vancomycin to prevent infection in shoulder surgery: intravenous (IV) and intraosseous (IO). Research has shown that delivering vancomycin directly into the bone (IO) during shoulder surgery is as effective as administering it through a vein (IV). This ensures the antibiotic reaches the target area efficiently. In some cases, IO vancomycin has better controlled antibiotic levels in the area. However, adding vancomycin to standard antibiotics like cefazolin has not proven more effective than a placebo in preventing infections in joint surgeries. Overall, both methods work well, but IO might deliver the drug more effectively to the surgical site. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

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

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

I am having shoulder replacement surgery.

I am older than 18 years.

Exclusion Criteria

I have had shoulder surgery before.

I do not wish to participate in the trial.

I have diabetes.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40472958/

Intraosseous vs. intravenous vancomycin administration in ... IORA VANC is a safe and effective method for antibiotic prophylaxis in TSA, achieving comparable local tissue concentrations with ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1058274625004276

Intraosseous vs. intravenous vancomycin administration in ... Intraosseous vs. intravenous vancomycin administration in total shoulder arthroplasty: comparable tissue concentrations with better control.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1058274625004276

Intraosseous vs. intravenous vancomycin administration in ... Intraosseous vs. intravenous vancomycin administration in total shoulder arthroplasty: comparable tissue concentrations with better control.

4. nejm.org nejm.org/doi/full/10.1056/NEJMoa2301401

Trial of Vancomycin and Cefazolin as Surgical Prophylaxis ... The addition of vancomycin to cefazolin prophylaxis was not superior to placebo for the prevention of surgical-site infections in arthroplasty.

5. withpower.com withpower.com/trial/phase-4-shoulder-injuries-3-2023-041a5

IO vs IV Vancomycin for Preventing Infection in Shoulder ... Intraosseous (IO) administration of vancomycin has shown to provide better local antibiotic concentration compared to intravenous (IV) methods in similar ...