Vancomycin Delivery Methods for Ankle Surgery
(IOTAA Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: The Methodist Hospital Research Institute
Disqualifiers: Previous surgery, BMI > 40, Uncontrolled diabetes, Immunocompromised, others
No Placebo Group
Prior Safety Data
Approved in 4 jurisdictions
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 ankle arthroplasty (TAA).
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 have a contraindication (a medical reason not to use) to certain antibiotics like vancomycin, you may not be eligible to participate.
What data supports the effectiveness of the drug Vancomycin for ankle surgery?
Research shows that applying vancomycin powder directly to the surgical site can reduce infections in diabetic patients undergoing foot and ankle surgery. This suggests it might help prevent infections in similar surgeries.
12345Is vancomycin safe for use in humans?
Vancomycin is generally safe for use in humans, but it can cause side effects like 'red neck syndrome' (redness and itching on the neck and upper back) if given too quickly through an IV. Serious side effects like kidney and ear problems are rare.
12678How is the drug Vancomycin used differently in ankle surgery compared to other treatments?
Vancomycin is unique in ankle surgery because it can be applied as a powder directly to the surgical site, which may help reduce infections, especially in diabetic patients. This local application is different from the usual intravenous (through the vein) administration used for other infections.
1291011Eligibility Criteria
This trial is for individuals undergoing total ankle arthroplasty who can safely receive vancomycin. It's not suitable for those with allergies to this antibiotic, other specific medical conditions that could interfere with the study, or those unable to follow the protocol.Inclusion Criteria
I am scheduled for total ankle replacement surgery.
I am older than 18 years.
Exclusion Criteria
I do not want to participate in the clinical trial.
My diabetes is not under control, with an A1C level over 7.5.
My BMI is over 40.
I cannot take certain antibiotics like vancomycin or cefepime due to allergies or other issues.
I have a weakened immune system due to a condition or treatment.
Participant Groups
The study compares two ways of giving vancomycin during ankle surgery: directly into the bone (intraosseous) versus into a vein (intravenous). The goal is to see if both methods result in similar drug levels in bone and tissue and have comparable infection rates after surgery.
2Treatment groups
Experimental Treatment
Active Control
Group I: Intraosseous VancomycinExperimental Treatment1 Intervention
IV antibiotics per physician's standard of care: Typically ancef or cefepime is started in pre-op within 1 hour of incision. IV Vancomycin will not be given preoperatively in this group.
IO vancomycin is administered in the OR after sterile prep and draping has occurred (500mg in 100-150mL NS).
IO Injection will take place into the medial malleolus.
Group II: Intravenous VancomycinActive Control1 Intervention
Patients will receive the orthopedic surgeon's standard of care pre-operative antibiotic regimen for TAA patients. This includes IV antibiotics (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 generally 1000-1750mg in 500mL normal saline (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
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Houston Methodist HospitalHouston, TX
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Who is running the clinical trial?
The Methodist Hospital Research InstituteLead Sponsor
References
Topically Applied Vancomycin Powder Reduces the Rate of Surgical Site Infection in Diabetic Patients Undergoing Foot and Ankle Surgery. [2018]The purpose of this study was to evaluate the efficacy of topically applied vancomycin powder in reducing the rate of surgical site infections (SSIs) in patients with diabetes mellitus (DM) undergoing foot and ankle surgery.
What Are the Benefits and Risks Associated With the Use of Vancomycin Powder in the Wound During Total Ankle Arthroplasty (TAA) or Other Foot and Ankle Procedures? [2022]Though one study supporting topically applied vancomycin has shown it to reduce the rate of deep infection in diabetic patients undergoing foot and ankle surgery, there is insufficient evidence to show benefits or to show any risks associated with the use of vancomycin powder during total ankle arthroplasty (TAA) or other foot and ankle procedures in a general population.
Intraoperative Site Vancomycin Powder Application in Infected Diabetic Heel Ulcers With Calcaneal Osteomyelitis. [2022]Intraoperative site application of vancomycin powder has been found to be beneficial in foot and ankle surgery among diabetic patients undergoing elective procedures. However, there are concerns for risks such as selection of multidrug-resistant bacteria, local tissue irritation, and increased wound complications. The clinical utility of intraoperative site vancomycin powder application in infected diabetic foot ulcer surgery is unknown. We aimed to report the clinical outcomes of partial or total calcanectomy for diabetic heel ulcer (DHU) and determine if intraoperative site application of vancomycin powder placement at the time of wound closure leads to improved clinical outcomes.
Impact of Vancomycin Treatment on Human Mesenchymal Stromal Cells During Osteogenic Differentiation. [2019]Vancomycin is frequently applied locally to the operative site during foot and ankle procedures to help prevent infection. Although the efficacy of locally applied vancomycin has been demonstrated in spine surgery, there is no consensus on dosing and indication within foot and ankle surgery. Osteogenic differentiation of human mesenchymal stromal cells (hMSCs) is key to healing of both fractures and arthrodesis. The purpose of this research was to determine the impact of vancomycin on human hMSCs during the process of osteogenic differentiation.
Local Intramedullary Delivery of Vancomycin Can Prevent the Development of Long Bone Staphylococcus aureus Infection. [2022]Current treatments for methicillin-resistant Staphylococcus aureus (MRSA) infections require intravenously delivered vancomycin; however, systemically delivered vancomycin has its problems. To determine the feasibility and safety of locally delivering vancomycin hydrochloride (~25 mg/Kg) to the medullary canal of long bones, we conducted a pharmacokinetics study using a rat tibia model. We found that administering the vancomycin intraosseously resulted in very low concentrations of vancomycin in the blood plasma and the muscle surrounding the tibia, reducing the risk for systemic toxicity, which is often seen with traditional intravenous administration of vancomycin. Additionally, we were able to inhibit the development of osteomyelitis in the tibia if the treatment was administered locally at the same time as a bacterial inoculum (i.e., Log10 7.82 CFU/mL or 6.62x107 CFU/mL), when compared to an untreated group. These findings suggest that local intramedullary vancomycin delivery can achieve sufficiently high local concentrations to prevent development of osteomyelitis while minimizing systemic toxicity.
Tolerability of teicoplanin in 117 hospitalized adults with previous vancomycin-induced fever, rash, or neutropenia: a retrospective chart review. [2013]Vancomycin has reliable antibacterial activity against many gram-positive pathogens but is associated with many adverse events. Teicoplanin, another glycopeptide, is associated with fewer adverse events, but its use in patients with previous vancomycin-induced adverse reactions remains controversial.
Local Antibiotic Therapy to Reduce Infection After Operative Treatment of Fractures at High Risk of Infection: A Multicenter, Randomized, Controlled Trial (VANCO Study). [2022]A number of clinical studies in the spine literature suggest that the use of local vancomycin powder may substantially reduce surgical site infections (SSIs). These studies are primarily retrospective and observational and few focus on orthopaedic trauma patients. This study is a phase III, prospective, randomized, clinical trial to assess the efficacy of locally administered vancomycin powder in the prevention of SSI after fracture surgery. The primary goal of the VANCO Study is to compare the proportion of deep SSI 6 months after fracture fixation surgery. A secondary objective is to compare species and antibacterial susceptibilities among study patients who develop SSI. An additional objective is to build and validate a risk prediction model for the development of SSI. The study population consists of patients aged 18-80 years with tibial plateau or pilon (tibial plafond) fractures, at higher risk of infection, and definitively treated with plate and screw fixation. Participants are block randomized (within center) in a 1:1 ratio to either treatment group (local vancomycin powder up to a maximum dose of 1000 mg, placed immediately before wound closure) or control group (standard of care) for each study injury location, and return to the clinic for evaluations at 2 weeks, 3 months, and 6 months after fixation. The targeted sample size for the study is 500 fractures per study arm. This study should provide important information regarding the use of local vancomycin powder during the definitive treatment of lower extremity fractures and has the potential to significantly reduce the incidence of infection after orthopaedic trauma.
Vancomycin: an update. [2019]Vancomycin is a narrow-spectrum glycopeptide antibiotic with potent antistaphylococcal activity. It is primarily active against gram-positive organisms. Bacterial resistance rarely develops due to its numerous modes of action. The toxic potential of vancomycin is less significant than previously thought. "Red neck syndrome" seems to be the most common side effect and appears to be caused by rapid intravenous infusion. It is characterized by erythema at the base of the neck and the upper back; hypotensive episodes may also occur. Nephrotoxicity and ototoxicity are rare. Relationships between toxicities and serum concentrations have not been established. The disposition of vancomycin after intravenous administration proceeds biphasically--rapid distribution followed by elimination. The drug is excreted primarily unchanged in the urine by glomerular filtration. Vancomycin clearance is reduced and elimination half-life is prolonged in patients with renal insufficiency. Various methods have been published to aid in dosing the drug in these patients. Vancomycin is the drug of choice in the treatment of methicillin-resistant staphylococcal infections. It is also useful in the treatment of gram-positive endocarditis and has been used as alternative therapy in the treatment of prophylaxis of gram-positive infections in penicillin-allergic patients. Oral vancomycin is the preferred therapy in antibiotic-associated colitis.
Vancomycin. [2013]Vancomycin is a narrow-spectrum bactericidal antistaphylococcal antibiotic that was introduced in 1956 because of its efficacy against resistant penicillinase-producing staphylococci. It was effective for serious staphylococcal infections for which no satisfactory alternative to penicillin G was available at the time. When methicillin and the other semisynthetic penicillins and the cephalosporins were introduced, the role of vancomycin was relegated to the alternative therapy of choice when the penicillins and the cephalosporins could not be used. In the future, vancomycin may be used more frequently in (1) methicillin-resistant Staphylococcus aureus infections, (2) streptococcal endocarditis in conjunction with an aminoglycoside in patients intolerant to penicillin or ampicillin, (3) infections associated with prosthetic devices caused by organisms with multiple antibiotic resistance, and (4) antibiotic-induced enterocolitis associated with Clostridium difficile.
Local delivery of tobramycin and vancomycin in primary total knee arthroplasty achieves minimum inhibitory concentrations for common bacteria causing acute prosthetic joint infection. [2020]The aim of this study was to determine if the local delivery of vancomycin and tobramycin in primary total knee arthroplasty (TKA) can achieve intra-articular concentrations exceeding the minimum inhibitory concentration thresholds for bacteria causing acute prosthetic joint infection (PJI).
Vancomycin: a history. [2013]Vancomycin became available for clinical use >50 years ago but was soon discarded in favor of other antibiotics that were deemed to be more efficacious and less toxic. The advent of pseudomembranous enterocolitis, coupled with the spread of methicillin-resistant Staphylococcus aureus, led to a resurgence in the use of vancomycin. Almost immediately, concerns arose with regard to its therapeutic utility. In addition, resistance to vancomycin developed, first in enterococci and later in staphylococci. Several types of resistance have now been identified, each with a unique effect on infections treated with vancomycin. Recent studies have rekindled interest in the best way to administer the antibiotic. The findings of future studies may result in a return to measuring levels of vancomycin in serum, to assure a successful therapeutic outcome.