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A Novel Method to Determine the Longitudinal Antibacterial Activity of Drug-Eluting Materials
Published on: March 3, 2023
Safety of locally applied antibiotics in orthopaedic trauma surgery: descriptive results from a prospective cohort
Niels Vanvelk1, Esther M M Van Lieshout1, Leendert H T Nugteren1
1Trauma Research Unit, Department of Surgery, Erasmus MC, University Medical Center Rotterdam, Rotterdam, the Netherlands.
Abstract:
Antibiotic therapy holds an integral role in the prevention and treatment of fracture-related infection (FRI). Because local concentrations after systemic administration are limited by the potential for side effects, the local application of antibiotics serves as a valuable adjunct. One concern with the local administration of high amounts of aminoglycosides and vancomycin is the absorption into the systemic circulation, leading to detrimental effects on renal function. In this study, serum antibiotic concentration and renal function were measured in patients treated for open fractures or FRI using local antibiotics at 6, 24 and 48 h postoperatively. Afterwards, laboratory analyses were continued daily until the concentration dropped beneath the lower limit of quantification (LLOQ) (0.22 mg L-1 for gentamicin, 0.70 mg L-1 for vancomycin). Gentamicin concentration, vancomycin concentration and glomerular filtration rate were measured 272, 60 and 277 times in 52 patients after 82 surgeries, respectively. The LLOQ for gentamicin was exceeded in 14 surgeries (17 %, median concentration 0.3 mg L-1). The highest measured antibiotic level was 1.0 mg L-1, well below the generally accepted toxic trough level of 2.0 mg L-1. Although the total quantity of antibiotics delivered via beads was less than that provided by an antibiotic spacer, the use of beads more frequently yielded measurements exceeding the established threshold. None of the vancomycin measurements surpassed the LLOQ. The results of this study suggest that the current clinical use of locally applied antibiotics in orthopaedic trauma surgery is safe in the context of nephrotoxicity. The type of antibiotic carrier might affect local release and subsequent systemic absorption, which must be considered.
Insights
Local antibiotic application in fracture-related infection (FRI) treatment is safe, with serum levels below toxic thresholds. This study monitored gentamicin and vancomycin levels and renal function, finding no significant nephrotoxicity concerns in patients undergoing orthopaedic trauma surgery.
Area of Science:
- Orthopaedic Surgery
- Pharmacology
- Infectious Disease
Background:
- Antibiotic therapy is crucial for preventing and treating fracture-related infections (FRI).
- Local antibiotic administration is a valuable adjunct to systemic therapy, but concerns exist regarding systemic absorption and potential nephrotoxicity, especially with aminoglycosides and vancomycin.
- Monitoring serum antibiotic concentrations and renal function is essential when using local antibiotic delivery systems.
Purpose of the Study:
- To evaluate the safety of local antibiotic application in orthopaedic trauma surgery by measuring serum antibiotic concentrations and renal function.
- To determine if local antibiotic delivery systems lead to systemic absorption and potential nephrotoxicity.
- To compare the systemic absorption profiles of different local antibiotic carriers.
Main Methods:
- Serum concentrations of gentamicin and vancomycin and glomerular filtration rate were measured postoperatively in patients treated with local antibiotics for open fractures or FRI.
- Measurements were taken at 6, 24, and 48 hours, and daily thereafter until antibiotic levels fell below the lower limit of quantification (LLOQ).
- A total of 272 gentamicin, 60 vancomycin, and 277 glomerular filtration rate measurements were collected from 52 patients after 82 surgeries.
Main Results:
- The LLOQ for gentamicin was exceeded in 17% of surgeries, with a median concentration of 0.3 mg/L, well below the toxic trough level of 2.0 mg/L.
- No vancomycin measurements surpassed the LLOQ.
- While antibiotic beads delivered less total antibiotic than spacers, they more frequently yielded detectable systemic levels. The type of antibiotic carrier influenced local release and systemic absorption.
Conclusions:
- Current clinical use of locally applied antibiotics in orthopaedic trauma surgery appears safe regarding nephrotoxicity.
- Systemic absorption of locally administered antibiotics is generally low and does not reach toxic levels.
- The choice of antibiotic carrier is an important factor influencing drug release and systemic absorption, warranting careful consideration.
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