Double-blind randomized clinical trial of vancomycin in spinal arthrodesis: no effects on surgical site infection

J Neurosurg Spine 32:473–480, 2020

Surgical site infection (SSI) results in high morbidity and mortality in patients undergoing spinal fusion. Using intravenous antibiotics in anesthesia induction reduces the rate of postoperative infection, but it is not common practice to use them topically, despite recent reports that this procedure helps reduce infection. The objective of this study was to determine whether the topical use of vancomycin reduces the rate of postoperative SSI in patients undergoing thoracolumbar fusion.

METHODS A randomized, double-blind clinical trial in a single hospital was performed comparing vancomycin and placebo in thoracolumbar fusion patients.

RESULTS A total of 96 patients were randomized to placebo or vancomycin treatment. The mean patient age was 43 ± 14.88 years, 74% were male, and the most common etiology was fall from height (46.9%). The overall rate of postoperative SSI was 8.3%, and no difference was found between the groups: postoperative infection rates in the vancomycin and placebo groups were 8.2% and 8.5% (relative risk [RR] of SSI not using vancomycin 1.04, 95% confidence interval [CI] 0.28–3.93, p = 0.951), respectively. Patients with diabetes mellitus had higher SSI rates (RR 8.98, 95% CI 1.81–44.61, p = 0.007).

CONCLUSIONS This is the first double-blind randomized clinical trial to evaluate the effects of topical vancomycin on postoperative infection rates in thoracolumbar fusion patients, and the results did not differ significantly from placebo. Clinical trial registration no.: RBR-57wppt (ReBEC; http://www.ensaiosclinicos.gov.br/)

 

Topical Vancomycin Reduces Surgical-Site Infections After Craniotomy: A Prospective, Controlled Study

Neurosurgery 83:761–767, 2018

Surgical-site infections (SSIs) are an important cause of morbidity and mortality in neurosurgical patients. Topical antibiotics are one potential method to reduce the incidence of these infections.

OBJECTIVE: To examine the efficacy of topical vancomycin applied within the wound during craniotomy in a large prospective cohort study at a major academic center.

METHODS: Three hundred fifty-five patients were studied prospectively in this cohort study; 205 patients received 1 g of topical vancomycin powder in the subgaleal space while 150 matched control patients did not. Patients otherwise received identical care. The primary outcome variable was SSI rate factored by cohort. Secondary analysis examined cost savings from vancomycin usage estimated from hospital costs associated with SSI in craniotomy patients.

RESULTS: The addition of topical vancomycinwas associated with a significantly lower rate of SSI than standard of care alone (0.49% [1/205] vs 6% [9/150], P=.002). Based on the costs of revision surgery for infections, topical vancomycin usage was estimated to save $1367 446 per 1000 craniotomy patients. No adverse reactions occurred.

CONCLUSION: Topical vancomycin is a safe, effective, and cost-saving measure to prevent SSIs following craniotomy. These results have broad implications for standard of care in craniotomy.

Intrawound Vancomycin Decreases the Risk of Surgical Site Infection After Posterior Spine Surgery: A Multicenter Analysis

Spine 2018;43:65–71

Study Design. Secondary analysis of data from a prospective multicenter observational study.

Objective. The aim of this study was to evaluate the occurrence of surgical site infection (SSI) in patients with and without intrawound vancomycin application controlling for confounding factors associated with higher SSI after elective spine surgery.

Summary of Background Data. SSI is a morbid and expensive complication associated with spine surgery. The application of intrawound vancomycin is rapidly emerging as a solution to reduce SSI following spine surgery. The impact of intrawound vancomycin has not been systematically studied in a welldesigned multicenter study.

Methods. Patients undergoing elective spine surgery over a period of 4 years at seven spine surgery centers across the United States were included in the study. Patients were dichotomized on the basis of whether intrawound vancomycin was applied. Outcomes were occurrence of SSI within postoperative 30 days and SSI that required return to the operating room (OR). Multivariable random-effect log-binomial regression analyses were conducted to determine the relative risk of having an SSI and an SSI with return to OR.

Results. A total of 2056 patients were included in the analysis. Intrawound vancomycin was utilized in 47% (n=966) of patients. The prevalence of SSI was higher in patients with no vancomycin use (5.1%) than those with use of intrawound vancomycin (2.2%). The risk of SSI was higher in patients in whom intrawound vancomycin was not used (relative risk (RR) – 2.5, P<0.001), increased number of levels exposed (RR -1.1, P=0.01), and those admitted postoperatively to intensive care unit (ICU) (RR -2.1, P=0.005). Patients in whom intrawound vancomycin was not used (RR -5.9, P<0.001), increased number of levels were exposed (RR-1.1, P=0.001), and postoperative ICU admission (RR -3.3, P<0.001) were significant risk factors for SSI requiring a return to the OR.

Conclusion. The intrawound application of vancomycin after posterior approach spine surgery was associated with a reduced risk of SSI and return to OR associated with SSI.

Level of Evidence: 2

Does Intrawound Vancomycin Application During Spine Surgery Create Vancomycin-Resistant Organism?

Neurosurgery (2017) 80 (5): 746-753

Surgical site infection (SSI) following spine surgery is a morbid and expensive complication. The use of intrawound vancomycin is emerging as a solution to reduce SSI. The development of vancomycin-resistant pathogens is an understandable concern.

OBJECTIVE: To determine the occurrence of vancomycin-resistant SSI in patients with and without use of intrawound vancomycin.

METHODS: Patients undergoing elective spine surgery were dichotomized based on whether intrawound vancomycin was applied. Outcome was occurrence of SSI requiring return to the operating room within postoperative 90 days. The intrawound culture and vancomycin minimal inhibitory concentrations (MIC) were reviewed. Analyses were conducted to compare the pathogen profile and MIC for vancomycin in patients who received vancomycin and those who did not.

RESULTS: Of the total 2802 patients, 43% (n = 1215) had intrawound vancomycin application during the index surgery. The use of vancomycin was associated with significantly lower deep SSI rates (1.6% [n = 20] vs 2.5% [n = 40], P = .02). The occurrence of Staphylococcus aureus SSI was significantly lower in the patients who had application of intrawound vancomycin (32% vs 65%, P = .003). None of the patients who had application of intrawound vancomycin powder, and subsequently developed an S aureus SSI, demonstrated pathogens with resistance to vancomycin. All patients had MIC < 2 μg/mL, the vancomycin susceptibility threshold. The occurrence of gram-negative SSI (28% vs 7%) and culture negative fluid collection (16% vs 5%) was higher in the vancomycin cohort.

CONCLUSIONS: The use of intrawound vancomycin during the index spine surgery was protective against SSI following spine surgery. The application of intrawound vancomycin during index surgery does not appear to create vancomycin-resistant organisms in the event of an SSI.

Stereoelectroencephalography-guided radiofrequency thermocoagulation in the epileptogenic zone

Reducing surgical site infections following craniotomy- examination of the use of topical vancomycin

J Neurosurg 123:1600–1604, 2015

Although the use of topical vancomycin has been shown to be safe and effective for reducing postoperative infection rates in patients after spine surgery, its use in cranial wounds has not been studied systematically. The authors hypothesized that topical vancomycin, applied in powder form directly to the subgaleal space during closure, would reduce cranial wound infection rates.

Methods A cohort of 150 consecutive patients who underwent craniotomy was studied retrospectively. Seventy-five patients received 1 g of vancomycin powder applied in the subgaleal space at the time of closure. This group was compared with 75 matched-control patients who were accrued over the same time interval and did not receive vancomycin. The primary outcome measure was the presence of surgical site infection within 3 months. Secondary outcome measures included tissue pH from a subgaleal drain and vancomycin levels from the subgaleal space and serum.

Results Vancomycin was associated with significantly fewer surgical site infections (1 of 75) than was standard antibiotic prophylaxis alone (5 of 75; p < 0.05). Cultures were positive for typical skin flora species. As expected, local measured vancomycin concentrations peaked immediately after surgery (mean ± SD 499 ± 37 μg/ml) and gradually decreased over 12 hours. Vancomycin in the circulating serum remained undetectable. Subgaleal topical vancomycin was associated with a lower incidence of surgical site infections after craniotomy. The authors attribute this reduction in the infection rate to local vancomycin concentrations well above the minimum inhibitory concentration for antimicrobial efficacy.

Conclusions Topical vancomycin is safe and effective for reducing surgical site infections after craniotomy. These data support the need for a prospective randomized examination of topical vancomycin in the setting of cranial surgery.