Negligible Systemic Uptake of Suprafascial Vancomycin Powder Following Instrumented Posterior Spinal Fusion

Neurosurgery 89:967–972, 2021

Intrawound vancomycin powder is an emerging strategy to reduce surgical site infections (SSIs) in spine surgery. However, there are concerns relating to its safety profile and toxicity. Data on systemic uptake of suprafascially administered vancomycin powder following instrumented spinal fusion is lacking.

OBJECTIVE: To study the systemic uptake and safety of suprafascially administered vancomycin powder in the early postoperative phase following open instrumented posterior spinal fusion.

METHODS: This was a substudy of an ongoing randomized clinical trial. Eligible adult patients were randomized 1:1 to either receive suprafascial vancomycin powder before wound closure or not to receive vancomycin powder. Serum vancomycin levels were assessed on postoperative days 1 and 2, serum creatinine levels were measured pre- and post-operatively. Adverse events up to 6 wk following surgery were recorded.

RESULTS:Among34 randomized patients (mean age 62 yr, range 31-84 yr; 18 [53%]women), 17 received vancomycin powder. No detectable serum vancomycin levels (>4.0mg/L)were found. Proportion of adverse events per patient in the vancomycin and control group, respectively,were 29.4% (5/17) vs 11.8% (2/17) (OR 3.12;95%CI, 0.52; 19.38; P=.398).No patient had nephrotoxicity or ototoxicity in either group. CONCLUSION: Suprafascial vancomycin powder in open instrumented spinal fusion surgery is safe and results in negligible systemic uptake. Final results of the VANCO Trial need to be awaited for conclusive data on the efficacy of vancomycin for SSI prevention and its impact on wound healing.

 

Removal of instrumentation for postoperative spine infection: systematic review

J Neurosurg Spine 35:376–388, 2021

Currently, no consensus exists as to whether patients who develop infection of the surgical site after undergoing instrumented fusion should have their implants removed at the time of wound debridement. Instrumentation removal may eliminate a potential infection nidus, but removal may also destabilize the patient’s spine. The authors sought to summarize the existing evidence by systematically reviewing published studies that compare outcomes between patients undergoing wound washout and instrumentation removal with outcomes of patients undergoing wound washout alone. The primary objectives were to determine 1) whether instrumentation removal from an infected wound facilitates infection clearance and lowers morbidity, and 2) whether the chronicity of the underlying infection affects the decision to remove instrumentation.

METHODS PRISMA guidelines were used to review the PubMed/MEDLINE, Embase, Cochrane Library, Scopus, Web of Science, and ClinicalTrials.gov databases to identify studies that compared patients with implants removed and patients with implants retained. Outcomes of interest included mortality, rate of repeat wound washout, and loss of correction.

RESULTS Fifteen articles were included. Of 878 patients examined in these studies, 292 (33%) had instrumentation removed. Patient populations were highly heterogeneous, and outcome data were limited. Available data suggested that rates of reoperation, pseudarthrosis, and death were higher in patients who underwent instrumentation removal at the time of initial washout. Three studies recommended that instrumentation be uniformly removed at the time of wound washout. Five studies favored retaining the original instrumentation. Six studies favored retention in early infections but removal in late infections.

CONCLUSIONS The data on this topic remain heterogeneous and low in quality. Retention may be preferred in the setting of early infection, when the risk of underlying spine instability is still high and the risk of mature biofilm formation on the implants is low. However, late infections likely favor instrumentation removal. Higher-quality evidence from large, multicenter, prospective studies is needed to reach generalizable conclusions capable of guiding clinical practice.

Effect of Incisional Negative Pressure Wound Therapy vs Standard Wound Dressing on the Development of Surgical Site Infection after Spinal Surgery: A Prospective Observational Study

Neurosurgery 88:E445–E451, 2021

Use of a closed-incisional negative pressure therapy (ci-NPT) dressing is an emerging strategy to reduce surgical site infections (SSIs) in spine surgery that lacks robust data.

OBJECTIVE: To determine the impact of a ci-NPT, as compared with a standard dressing, on the development of SSIs after spine surgery.

METHODS: This was a prospective observational study over a 2-yr period. Indications for surgery included degenerative disease, deformity, malignancy, and trauma. Exclusion criteria included anterior and lateral approaches to the spine, intraoperative durotomy, or use of minimally invasive techniques. SSIs up to 60d following surgery were recorded.

RESULTS: A total of 274 patients were included. SSI rate was significantly lower with ci-NPT dressing (n = 118) as compared with the standard dressing (n = 156) (3.4 vs 10.9%, P = .02). There was no statistical difference in infection rate for decompression alone procedures (4.2 vs 9.1%, P = .63), but there was a statistically significant reduction with the use of a negative-pressure dressing in cases that required instrumentation (3.2 vs 11.4%, P = .03). Patients at higher risk (instrumentation, deformity, and malignancy) had less SSIs with the use of ci-NPT, although this did not reach statistical significance. There were no complications in either group.

CONCLUSION: SSI rates were significantly reduced with a ci-NPT dressing vs a standard dressing in patients who underwent spinal surgery. The higher cost of a ci-NPT dressing might be justified with instrumented cases, as well as with certain high-risk patient populations undergoing spine surgery, given the serious consequences of an infection.

Intrawound vancomycin application after spinal surgery: a propensity score–matched cohort analysis

J Neurosurg Spine 34:788–798, 2021

Surgical site infection (SSI) following spine surgery is associated with increased morbidity and healthcare costs. In an effort to reduce SSI rates, the application of intrawound vancomycin powder has gained popularity. However, there is limited high-quality evidence to support the safety and efficacy of this practice. The authors sought to determine if intrawound application of vancomycin powder improves 90-day overall SSI rates.

METHODS The authors performed a retrospective, vancomycin exposure–matched cohort study at a single tertiary care hospital over 21 months. They included all patients undergoing elective spinal surgery and stratified the patients into two groups: those who received intrawound vancomycin powder application and those who received no application of vancomycin powder. The primary outcome of interest was the 90-day overall SSI rate. Secondary outcomes included rates of superficial SSI, deep SSI, wound disruption, and a post hoc analysis of the microbiology and minimum inhibitory concentrations. Baseline patient demographics, clinical presentation, comorbidities, perioperative factors, and 90-day postoperative outcomes were manually abstracted from patient charts. To mitigate bias, we performed 1:1 matching after calculating propensity scores and identified 1 patient from the no-vancomycin cohort for each patient in the vancomycin cohort.

RESULTS A total of 997 patients met our inclusion criteria (473 patients receiving vancomycin and 524 patients not receiving vancomycin). Propensity score matching produced 221 matched pairs. Risk-adjusted analysis demonstrated similar overall SSI rates between the groups (OR 1.9, p = 0.329). On unadjusted analysis, the overall 90-day SSI rate was greater in the vancomycin group (n = 10 [4.5%]) than in the no-vancomycin group (n = 5 [2.3%]) (p < 0.001), as were the superficial SSI rate (7 [3.2%] vs 4 [1.8%], p < 0.001), deep SSI rate (3 [1.4%] vs 1 [0.5%], p < 0.001), and wound disruption rate (5 [2.3%] vs 1 [0.5%], p < 0.001). No cultured isolate demonstrated vancomycin resistance.

CONCLUSIONS The authors observed no difference in SSI rates after the intrawound application of vancomycin powder during spine surgery. Vancomycin use did not contribute to antimicrobial resistance; however, it may select out gram negative bacteria and increase rates of wound disruption.

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

Frontal Sinus Breach During Routine Frontal Craniotomy

Neurosurgery 81:504–511, 2017

Frontotemporal craniotomies are commonly performed for a variety of neurosurgical pathologies. Infections related to craniotomies cause significant morbidity. We hypothesized that the risk of cranial surgical site infections (SSIs) may be increased in patients whose frontal sinuses are breached during craniotomy.

OBJECTIVE: To compare the rate of cranial SSIs in patients undergoing frontotemporal craniotomies with and without frontal sinus breach (FSB).

METHODS: We performed a retrospective analysis of all patients undergoing frontotemporal craniotomies for the management of cerebral aneurysms from 2005 to 2014. This study included 862 patients undergoing 910 craniotomies. Primary outcomeof interest was occurrence of a cranial SSI. Standard statistical methods were utilized to explore associations between a variety of variables including FSB, cranial SSI, and infections requiring reoperation.

RESULTS: Of the 910 craniotomies, 141 (15.5%) involved FSB. Of those involving FSB, 22 (15.6%) developed a cranial SSI, compared to only 56 of the 769 without FSB (7.3%; P = .001). Cranial SSI requiring reoperation wasmuch more likely in patients with FSB compared to those without a breach (7.8% vs 1.6%; P < .001). In those presenting with cranial SSIs, epidural abscess formation was more common with FSB compared to no FSB (27.3% vs 5.4%; P = .006). In multivariate analysis, breach of the frontal sinus was significantly associated with cranial SSI (OR 2.16; 95% CI 1.24-3.78; P = .01) and reoperation (OR 4.20; 95% CI 1.66-10.65; P = .003).

CONCLUSION: Patients undergoing frontotemporal craniotomies are at significantly greater risk of serious cranial SSIs if the frontal sinus has been breached.

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.

The Use of Vancomycin Powder for Surgical Prophylaxis Following Craniotomy

Neurosurgery 80:754–758, 2017

Intrawound vancomycin powder has been studied extensively in spinal fusion surgeries and been found to reduce rates of surgical site infections (SSIs) significantly. Despite its success in spinal surgeries, topical vancomycin has not been extensively studied with respect to cranial neurosurgery.

OBJECTIVE: To evaluate the efficacy of intrawound topical vancomycin for prevention of SSIs following open craniotomies.

METHODS: We retrospectively analyzed a large series of 350 patients from 2011 to 2015 in a pre/postintervention study of use of topical vancomycin to reduce postoperative craniotomy infection rates. We had a preintervention control group of 225 patients and a postintervention group of 125 patients that received intrawound topical vancomycin.

RESULTS: Our preintervention incidence of SSI was 2.2% and this was significantly reduced to 0% following introduction of topical vancomycin (P < .5). An ad hoc cost analysis suggested a cost savings of $59 965 with the use of topical vancomycin for craniotomies.

CONCLUSION: Our study found a significant reduction in SSI rates after introduction of topical vancomycin. Thus, this simple intervention should be considered in all open craniotomy patients as both infection prophylaxis and a potential cost saving intervention.

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.

Absence of an association between glucose levels and surgical site infections in patients undergoing craniotomies for brain tumors

J Neurosurg 113:161–166, 2010.DOI: 10.3171/2010.2.JNS09950

In select patient populations, hyperglycemia has been shown to increase the risk of surgical site infection (SSI), whereas stringent glucose control has improved outcomes. To date, no study has focused on whether SSIs in patients with brain tumors undergoing resection are associated with hyperglycemia. Methods. The authors performed a retrospective chart review of patients who underwent a craniotomy after receiving a diagnosis of brain tumor. From 2001 to 2008, 2485 patients underwent a craniotomy for tumor resection at the Brain Tumor & Neuro-Oncology Center at the Cleveland Clinic. Fifty-seven of these patients (2.3%) developed SSIs postoperatively. A matched case-control study design was used, with 57 patients who developed SSIs after craniotomy (cases) matched with 57 patients who did not develop SSIs (controls). The results were analyzed using both univariate and multivariate conditional logistic regression. Results. Glucose level was not a significant factor in postoperative SSI (p = 0.83) after adjusting for duration of surgery and adherence to antibiotic prophylaxis. However, duration of surgery was significantly associated with postoperative SSI (p = 0.047). Conclusions. For patients who undergo craniotomy for definitive resection of a brain tumor, duration of surgery described more variation in the model to predict SSI than blood glucose levels.