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Abstract

Introduction

Surgical site infection (SSI) risk increases with surgical invasiveness, yet most spine surgeons do not adjust perioperative antibiotics based on surgical complexity. The purpose of this study was to evaluate the impact of tiered perioperative antibiotic coverage in spine surgery.

Methods

A retrospective review was conducted on patients who underwent spine surgery between 2007 and 2013 at a tertiary spine center. Trauma and deformity patients were included in the analysis. All study patients had standardized skin preparation with 3% chlorhexanol, alcohol, DuraPrep^TM, and Ioban incise drape. SSIs were compared to historical data and classified as superficial, deep, or delayed deep. “Simple” cases (e.g., decompression alone, corpectomy alone, or ACDF alone) received cefazolin + gentamicin, while “complex” cases (instrumentation, front-back procedures, diabetic, obesity, trauma, etc.) received vancomycin + piperacillin/tazobactam or ceftazidime.

Results

Among 2162 patients, the overall SSI rate improved to 0.37%, with four superficial, three deep, and one delayed deep infection. MSSA, MRSA, and coagulase-negative staphylococci were the most common organisms. No vancomycin-resistant organisms were reported. Post-operative C. difficile was 0.19%.

Discussion

Tiered antibiotic prophylaxis with gram-positive and gram-negative microbial coverage resulted in low SSI rates, demonstrating the effectiveness of tailored antibiotic coverage based on case complexity. Further prospective studies are needed to validate these findings.

Keywords

surgical site infection antibiotics protocol spine antiseptic

Introduction

Surgical site infection (SSI) following spine surgery is a potentially devastating complication leading to increased morbidity, mortality, and worse patient-reported outcomes.^1,2 SSIs also pose a marked financial burden to patients, with the mean U.S. cost exceeding $100,000 per case.^3,4 SSI incidence varies from 0.2% to 16.1% and is attributed to procedural surgical complexity, patient, and environmental factors.^3,5-16 As the population ages, the frequency of spine surgery and, thus, SSI following spine surgery are expected to increase.¹⁷

Multiple factors are known to increase the risk of infection, including diabetes, obesity, body habitus, increased age, surgical complexity, blood transfusion, previous SSI, revision surgery, malnutrition, prolonged steroid use, and neurologic deficit.^3,5,18-22 SSIs are ultimately due to wound contamination by pathogenic bacteria, with Staphylococcal species accounting for more than half of these infections.^16,23,24

Staphylococcus aureus, while only colonized by an estimated 25% of individuals, accounts for upwards of 50% of SSIs, with Methicillin-resistant strains found in up to 30% of cases.^16,21,23,25 Staphylococcus epidermidis is likewise common, accounting for up to 30% of infections, and demonstrates a significant association with the insertion of instrumentation.^16,21,23 Other common causative organisms include gram-negative bacteria such as Pseudomonas, Klebsiella, Proteus, and E. coli, anaerobic species such as Cutibacterium acnes, and yeast such as Candida albicans.^26-28 Unfortunately, there has been a rise in recent years of SSIs attributed to antibiotic-resistant strains, further necessitating the need for effective preventative measures.^23,24,29

Rates of SSI differ by anatomical location, the most frequent being thoracic (3.7%), followed by cervical (3.4%), and lumbar (2.7%).¹⁶ SSIs may be further classified based on tissue location and chronology as superficial, deep, or delayed deep, as defined by the Centers for Disease Control (CDC)/National Healthcare Safety Network guidelines.³⁰ The American College of Surgeons-National Surgical Quality Improvement Program (ACS-NSQIP) SSI definition is also frequently used; however, there is no standardized definition of a postoperative spine infection.^31-34

Continued attention has resulted in progress toward identifying important risk factors and new techniques for their prevention. Local antibiotic delivery, such as in-wound vancomycin powder, has gained significant traction.^9,15,35-38 However, there is still a lack of high-level evidence regarding best practices and antibiotic prophylaxis. This may be due to systemic under-reporting of SSI rates, leading to a low aggregate.

Much has been done to identify factors that would lower the rates of SSI in recent years.^9,15,35-38 To that end, the purpose of this study was to evaluate the impact of tiered perioperative antibiotic coverage in spine surgery.

Methods

Patients

A retrospective review of prospectively collected data was performed to evaluate all adult patients >18 years of age undergoing spine surgery performed by fellowship-trained and board-certified spine surgeons at a tertiary referral center between January 1, 2007, and December 31, 2013. Patient records were individually reviewed. Surgery characteristics, including vertebral level and SSI, were recorded. Cases were classified as complicated or uncomplicated. “Simple” cases were healthy patients receiving decompression alone or ACDF. “Complex” cases were those receiving posterior instrumentation or considered high-risk (Table 1).

Table 1.

Patient and Surgical Characteristics That Led to Categorization as “Simple” Versus “Complex” Case

“Simple” procedure

Discectomy

Laminectomy

Anterior cervical discectomy fusion (ACDF)

Cervical corpectomy

“Complex” procedure

Instrumented thoracolumbar fusion

Instrumented posterior cervical fusion

Combined anterior & posterior spinal instrumented fusion

Other indications for “complex” antibiotic protocol

Trauma

Deformity

Immunosuppression

Revision surgery

Outcomes

Each SSI was categorized as superficial, deep, or delayed deep. These categories are defined as superficial: ≤90 days involving superficial or subcutaneous tissues only, deep: ≤90 days involving deep subfascial space, based on the National Surgical Quality Improvement Programs and the Centers for Disease Control guidelines.³⁰ Delayed deep infections were defined as those occurring >90 days, involving the deep subfascial space. Patients who had primary infections, infections attributed to a procedure performed by another surgeon, or post-SSI wound debridement were excluded. Institutional infectious disease data were used to further categorize SSI, causative organisms, and antibiotic susceptibility.

Surgical Site Preparation

All elective cases had strict preoperative patient selection criteria that were observed. In patients with diabetes mellitus, the HbA1c was required to be less than eight mmol/mol.^39,40 Patients identified as smokers underwent mandatory smoking cessation for a minimum of 6 weeks preoperatively. Abstinence was verified via urinalysis. BMI was recommended to be < 40. No specific protocol for nutrition existed over this period. No specific decolonization measures were employed. All complex deformity and trauma cases utilized two attending surgeons.

Skin preparation included hair removal, if necessary, followed by a 3% chlorhexanol skin scrub of the surgical site. The soap was allowed to rest for 2 minutes prior to removal. This was followed by a simple scrub with 70% isopropyl alcohol, which was allowed to dry. This was followed by final skin preparation with DuraPrep^TM solution (3M, St. Paul, MN), which was allowed to dry for the manufacturer’s recommended time. Incise draping was then performed with Ioban (3M, St. Paul, MN) (Figure 1).

Figure 1.

A schematic demonstrating surgical site preparation

Prophylactic Antibiotics

Standardized antibiotics included cefazolin and gentamicin for “simple” cases. Antibiotics were administered within 1 hour of incision and continued for 24 hours, barring same-day discharge. Complicated cases utilized vancomycin with piperacillin-tazobactam (Zosyn) or ceftazidime for gram-negative coverage (GNC). Antibiotics were continued until drain discontinuation. Adjustments were made based on patient allergies and renal function, and vancomycin levels were monitored by a trained pharmacist post-operatively. All antibiotics were re-dosed intraoperatively as needed (Table 2).

Table 2.

A Summary of the Antibiotic Prophylaxis Protocol Employed by Our Surgeons, Organized by Type of Procedure Performed

Procedure	Antibiotics	Duration
Simple	Cefazolin + gentamicin	Once* or 24 hrs
Complex	Vancomycin + gram-negative coverage (ceftazidime or piperacillin/tazobactam)	48 hrs. or drain removal

*In outpatient setting instead of inpatient.

Cefazolin 1 to 3g loading/maintenance based on weight (2g for 80-120 kg).

Gentamicin 3 mg/kg loading, 2 mg/kg Q12 hours maintenance.

Vancomycin 15 mg/kg loading, lab level-based maintenance.

Ceftazidime 1 gm IV Q8 hours loading/maintenance.

Piperacillin/tazobactam 3.375 g IV Q6 hours loading/maintenance.

Results

In total, 2162 patients were operated on during the study period. There were 8 SSIs (0.37%) with four superficial, three deep, and 1 delayed deep infection. The majority of patients had elevated BMI (>25), while a minority had risk factors, including myocardial infarction, renal failure, cardiovascular disease, and a history of cigarette smoking. The majority of procedures utilized implants and likewise involved fusion. There were four patients (0.19%) who developed Clostridium difficile infection. Patient demographics, risk factors, procedure characteristics, and infection rates are fully described in Table 3.

Table 3.

Demographic Characteristics, Risk Factors, Procedure Characteristics, and Infection Rates

	Surgeon 1	Surgeon 2
	N = 925	N = 1237
Demographics and risk factors
Average age (yrs.)	54	54
% Male	56%	47%
History of diabetes	18%	22%
History of myocardial infarction	7%	9%
History of renal failure	5%	7%
History of cerebrovascular disease	10%	10%
History of smoking	12%	11%
Under weight (BMI >18.5)	<1%	1%
Normal weight (BMI 18.5-25)	25%	22%
Overweight (BMI 25-30)	33%	32%
Obese (BMI 30-35)	35%	36%
Morbidly obese (BMI >35)	7%	9%
Procedure characteristics
Trauma*	10%	4%
Deformity**	19%	15%
Implant utilization	71%	54%
Cervical fusion	17%	15%
Thoracic/lumbar fusion	53%	37%
Laminectomy/discectomy***	26%	46%
Allogenic blood transfusion given	11%	8%
Infection rates
Superficial wound infection rate	0.32% (3)	0.08% (1)
Deep wound infection rate	0.22% (2)	0.08% (1)
Delayed deep wound infection rate	0.11% (1)	0% (0)
Combined infection rate	0.65%	0.16%
Rate of occurrence of C. difficile****	0.22% (2)	0.16% (2)

*Trauma cases defined by a code given to patients upon admission.

**Deformity cases identified using both CPT and ICD9-PCS codes and 5 or more levels with kyphosis or scoliosis.

***Laminectomy/Discectomy cases identified using both CPT and ICD9-PCS codes. ****A lab is returned, positive for C. difficile.

Among those who experienced SSI, six (75%) were female. The average time until diagnosis of infection was 66 days, respectively. Instrumentation was used in six (75%) cases, with Staphylococcal spp. implicated in 6 (75%) of infections. A single case had no identifiable organism, with another being due to Acinetobacter baumannii. The most frequent antibiotic regimen utilized when infection occurred was cefazolin and gentamycin, which occurred in five (63%) of cases. Individual case characteristics are further described in Table 4.

Table 4.

Summary of the Eight SSIs

Case no	Sex/Age (yrs.)	Procedure	Antibiotic use	Time to infection (days)	Infection type	Causative organism
1	F/58	Instrumented fusion	Ancef/Gentamycin	70	Superficial	MSSA
2	F/53	Instrumented fusion	Ancef/Gentamycin	31	Superficial	None identified
3	F/57	Instrumented fusion	Ancef/Gentamycin	27	Deep	MRSA & Staph. epidermidis
4	F/40	Discectomy	Ancef/Gentamycin	12	Superficial	MRSA
5	M/32	Instrumented fusion	Ancef/Gentamycin	28	Deep	MSSA
6	F/75	Instrumented fusion	Vancomycin/Zosyn	318	Delayed deep	MRSA
7	F/23	Instrumented fusion	Ancef only	11	Superficial	Acinetobacter baumannii
8	M/61	Laminectomy	Vancomycin and gentamycin*	28	Deep	MSSA

Cases 7 and 8 were performed by surgeon 2.

*Due to penicillin allergy.

The most commonly reported organisms involved in SSIs between 2007 and 2013 were MSSA, MRSA, and coagulase-negative staphylococcus spp. at 38%, 15%, and 21%, respectively. Cefazolin was effective against 100% of MSSA, 0% of MRSA, and 38% of coagulase-negative staphylococcus.

Gentamicin was effective against 98% of MSSA, 98% of MRSA, and 90% of coagulase-negative staphylococcus. Vancomycin was effective against 100% of MSSA, MRSA, and coagulase-negative staphylococcus. Ceftazidime was effective against 80% of MSSA and 0% of MRSA. And piperacillin/tazobactam was effective against 100% of MSSA, 0% of MRSA, and 38% of coagulase-negative staphylococcus. No vancomycin-resistant organisms were reported (Table 5).

Table 5.

Organisms Implicated in SSI With Their Susceptibilities

Infecting organism		Proportion of spine SSIs attributed to this organism across system (2007-2013)	Cefazolin sensitivity	Gentamicin sensitivity	Vancomycin sensitivity	Ceftazidime sensitivity	Piperacillin/tazobactam sensitivity
Gram-positive organisms	MSSA	38%	100%	98%	100%	80%	100%
	MRSA	15%	0%	98%	100%	0%	0%
	Coagulase-negative Staphylococci	21%	38%	90%	100%	—	38%
	E. faecalis	4%	—	—	100%	—	100%
	Peptostreptococcus	3%	—	—	—	—	—
	Alpha hemolytic streptococci	2%	—	—	—	—	—
	Diphtheroid	2%	—	—	—	—	—
	Other	3%	—	—	—	—	—
Gram-negative organisms	E. coli	10%	90%	94%	—	97%	97%
	Pseudomonas spp.	4%	—	87%	—	93%	97%
	K. pneumonia	2%	94%	98%	—	97%	96%
	Enterobacter cloacae	2%	—	98%	—	84%	88%
	Other	5%	—	—	—	—	—
Anaerobic organisms	Peptostreptococcus	3%	—	—	—	—	—
	Cutibacterium acnes	3%	—	—	—	—	—
	Other	3%	—	—	—	—	—

Discussion

Tired antibiotic prophylaxis results in reliably low rates of SSI in both “simple” and “complex” spine surgery. While guidelines to mitigate SSIs have been previously established in the literature through evidence-based methods, there is no accepted gold standard in antibiotic use or skin preparation.^5,7,35,41 This study reports an SSI rate of 0.37%, which compares favorably to the reported literature (0.2%-16.1%) and was achieved with standardized skin preparation with enhanced perioperative intravenous antibiotic prophylaxis.^3,5,13,16

Patient optimization before elective surgery, including managing diabetes (HbA1c < 7 mmol/mol), smoking cessation four weeks pre-op and 6 months post-op, and nutritional assessment are commonly reported to reduce the risk of postoperative SSI.^7,41-43 Such recommendations were incorporated in the study population, HbA1c < 8 mmol/mol was achieved for all elective patients, and the aforementioned guidelines regarding smoking were adhered to, which likely contributed to the overall low rate of SSI.

A 3% chlorhexanol scrub has been shown to reduce the risk of SSIs by upwards of 6.6% (9.5% vs 16.1%; P = 0.004) in superficial and deep infections⁴⁴; likewise, alcohol-based preparations have been significantly demonstrated to lower risk with minimal side effects.^36,45-48 However, this protocol also utilizes DuraPrep^TM, a solution with significantly better drape adhesion than chlorhexanol, aiding in the prevention of drape lift and subsequent contamination.^49,50 However, despite these measures, bacteria persist and proliferate within the skin structures, leading to contamination, with microbial counts at the wound site potentially reaching normal levels within three hours.^50-55 Adhesive incise drapes may theoretically prevent this process via barrier protection. While some studies have found little to no benefit to this practice,⁵⁶ others demonstrated that Iodine-impregnated incise drapes decrease bacteria counts under the drape and infection rates.^52,57-61

Local antibiogram showed that cefazolin demonstrated inadequate coverage of common causes of SSI (0% of MRSA and 38% of coagulase-negative staphylococcus). Gentamicin was effective against 98% of wound-site Staphylococcus aureus species and gram-negative bacteria, leading to its selection with cefazolin for uncomplicated procedures. Other studies have demonstrated similarly positive results with its use,^62-65 which may be due to its ability to penetrate the disc space.^8,66

In patients with significant risk factors or those who are undergoing complicated surgeries, a combination of vancomycin + piperacillin/tazobactam or ceftazidime was used. The use of Vancomycin is in line with that of the literature, with studies demonstrating a significant reduction in infection rates.^9,15,35-38 However, vancomycin should be administered conscientiously due to the risk of resistant strain or superinfection development. Although unconventional, the use of gentamicin and vancomycin is in line with the North American Spine Society (NASS) “Recommendations for Antibiotic Prophylaxis in Spine Surgery,” which recommends that for patients with comorbidities or those undergoing complicated procedures, an alternative prophylactic regimen with re-dosing, such as vancomycin or gentamicin, should be used to decrease the incidence of SSIs.^16,67,68

In a recent review of SSI, the most commonly isolated pathogen was Staphylococcus aureus (45.2%), followed by Staphylococcus epidermidis (31.4%).²¹ Methicillin-resistant organisms accounted for 34.3% of all SSIs and were more common in revision than in primary surgical procedures (47.4% vs 28.0%, P = 0.003). Gram-negative organisms were identified in 30.5% of the cases. Spine surgical procedures involving the sacrum were significantly associated with gram-negative organisms (P < 0.001) and polymicrobial infections (P = 0.020). Infections due to gram-negative organisms (P = 0.002) and Enterococcus spp. (P = 0.038) were less common in surgical procedures involving the cervical spine. Cefazolin-resistant gram-negative organisms accounted for 61.6% of all gram-negative infections and 18.8% of all SSIs.²¹

In another recent publication, the majority (57.5%) of infections were resistant to the prophylaxis administered during the procedure.⁶⁹ Cephalosporin-resistant gram-negative infection was common at lumbosacral levels, and undetected methicillin resistance was common at cervical levels. The most commonly isolated species were Enterobacter sp. (21.2%), Enterococcus spp. (15.3%), Pseudomonas aeruginosa (14.7%), Proteus spp. (8.8%), and Escherichia coli (7.6%). Overall, 68.8% of gram-negative SSI isolates were resistant to cefazolin, 53.4% were resistant to ceftriaxone, and 15.9% were resistant to gentamicin. A significant excess of gram-negative infection occurred in lumbosacral procedures. Given the large number of gram-negative infections in lumbosacral procedures and their high degree of resistance to cefazolin (68.8% in this study and 61.6% in another case series⁹), the suitability of cefazolin as a sole prophylactic agent in this subgroup must be critically examined. The data suggest that a systematic approach, matching the spectrum of prophylactic activity to the microbiology of the surgical site, may be more effective.

In wound antibiotic powder, specifically vancomycin, has gained traction.⁷⁰ However, there is some evidence to suggest relative gram-negative selection for subsequent post-operative infections when in-wound vancomycin is used. In-wound antibiotic powder or even administration through PMMA or calcium sulfate beads is transient in nature.⁷⁰ This, added to the growing body of evidence, suggests that IV or alternative administration pathways such as in-dwelling, in-wound devices may be a superior treatment strategy to powder or antibiotic beads alone.⁷¹

Limitations

Limitations of this study include the retrospective nature and lack of a true comparison group. Despite a large sample size, the study population was derived from a single geographical location with historical controls, which may limit generalizability. Further, the protocol was investigated as a whole rather than piecewise, limiting the ability to draw specific conclusions regarding which aspects may or may not have contributed significantly to the low infection rates. Individual patient follow-up timelines were not reported and should be considered in the future. Future research should investigate the protocol components piecewise.

Conclusions

Postoperative SSIs remain a significant problem deserving of attention in spine surgery. This case series demonstrates a protocol that effectively minimizes SSI rate (0.37%) compared to the reported rates (0.2%-16.1%).^3,5-13,16 Cefazolin alone does not provide adequate SSI prophylaxis against the organisms that cause SSIs in spine surgery. Less common antibiotics such as gentamicin, vancomycin, piperacillin/tazobactam, and ceftazidime have enhanced coverage and demonstrate positive results in reducing SSIs without increasing risk of antibiotic-related complications. Further prospective study is needed to further validate and extrapolate these data.

Footnotes

ORCID iDs

Nathan Barber

Anthony Oyekan

Ethical Considerations

IRB # 1050056.

Author Contributions

SW and RD collected and contributed to the data. NB, JDS, and SW performed the analysis and wrote the manuscript. AO performed manuscript editing.

Funding

The authors received no financial support for the research, authorship, and/or publication of this article.

Declaration of Conflicting Interests

The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: JDS serves as a scientific advisor to Globus Medical, Purgo Scientific and BoneSupport

Data Availability Statement

Data are available by request.*

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Tiered Antibiotic Coverage Reduces Surgical Site Infection in Spine Surgery

Abstract

Introduction

Methods

Results

Discussion

Keywords

Introduction

Methods

Patients

Outcomes

Surgical Site Preparation

Prophylactic Antibiotics

Results

Discussion

Limitations

Conclusions

Footnotes

ORCID iDs

Ethical Considerations

Author Contributions

Funding

Declaration of Conflicting Interests

Data Availability Statement

References