Abstract
Background:
A Care Bundle is proposed to prevent surgical site infections (SSIs). This study investigated SSI incidence and risk factors at our hospital, developed an SSI prevention Care Bundle, and tested its efficacy.
Methods:
A retrospective review of 1,117 patients who underwent spinal surgical procedure under general anesthesia (January 2016–July 2023) was conducted. A total of 764 patients (mean age 69.7 y, 58.0% female) were included. SSI was diagnosed as per U.S. Centers for Disease Control and Prevention’s guidelines. Risk factors evaluated included patient factors, operation-related factors, season, and Care Bundle implementation (introduced in April 2019). The Care Bundle included chlorhexidine gluconate bathing, skin disinfection, high-performance air purifier, glove changes, iodine-impregnated drapes, prophylactic antibiotic agents, and pre-operative sponge brushing.
Results:
SSI incidence was 2.6% (0.7% superficial, 1.9% deep), decreasing from 4.6% pre-Care Bundle to 1.0% post-implementation. Risk factors included smoking (p = 0.003), diabetes mellitus (p = 0.025), instrumentation (p = 0.039), posterior cervical operation (p = 0.049), and warm season (p = 0.024). Logistic regression identified Care Bundle implementation (odds ratio [OR] 0.27, p = 0.013), instrumentation (OR 3.59, p = 0.038), and warm season (OR 3.63, p = 0.025) as independent factors.
Conclusion:
The Care Bundle effectively reduced SSI. Certain factors such as instrumentation and surgical procedures during warm seasons were associated with greater SSI rates.
The incidence of surgical site infection (SSI) in spinal operations reported in the literature ranges from 0.7% to 11.9%.1–3 Spinal surgical procedures have a greater incidence of SSI than other general orthopedic operations,4,5 and SSI occurs with a certain frequency. Because of a wide variety of causes of SSIs, it is difficult to achieve a “zero” incidence rate. However, preventive measures are taken to reduce SSIs because of their substantial impact on patients’ quality of life and healthcare economics. In recent years, Care Bundles have been proposed as a method of SSI prevention. A key feature of Care Bundles is that multiple tactics are implemented simultaneously with substantially better results than if applied independently. 6 Several organizations, including the World Health Organization (WHO) 7 and U.S. Centers for Disease Control and Prevention (CDC), 8 have issued several new and revised guidelines for SSI prevention. However, these guidelines are not specific to any particular care and may exceed the capabilities of many hospitals in terms of cost, staffing, and importation of materials because of location limitations. We conducted a survey of Care Bundles but did not identify any specifically for spinal surgical procedure. Given the limitations associated with these WHO and CDC guidelines and lack of available spinal operation-specific Care Bundles, we developed our own SSI prevention Care Bundle specifically for spinal surgical procedure. Once implemented, we observed a substantial reduction in the incidence of SSIs. In this study, we investigated the incidence and risk factors of SSI in our hospital, developed our own Care Bundle, and examined the effectiveness of its implementation.
Patients and Methods
Study population
This was a retrospective single-center study. We reviewed the data of 1,117 patients who underwent spinal operation at our hospital between January 2016 and July 2023. The exclusion criteria were as follows: age <20 years, second operation for SSI at our hospital, biopsy, implant removal, balloon kyphoplasty, spinal endoscopy, post-operative epidural hematoma, and wound healing failure. Of the 1,117 patients reviewed, data from 764 patients were included in the study and 353 were excluded based on our exclusion criteria. Before the implementation of the bundle, there were 351 cases from 2016 to 2018 and 413 cases from 2019 to 2023 after implementation.
Diagnoses of SSI
The diagnoses of SSI were determined based on CDC definitions. 8 Patients with implants were followed up within 90 days, and those without implants were followed up within 30 days after the surgical procedure. SSI was diagnosed using magnetic resonance imaging in the presence of fever, pus, or inflammation. The depth of SSI was classified as either superficial incisional or severe (deep incisional or organ cavity which are grouped together as the differences between deep and organ cavities are usually difficult to differentiate).
Outcome measures
The primary outcome measures were the incidence of SSI and effectiveness of Care Bundle implementation. The evaluation data points included patient factors (age, gender, body mass index [BMI], smoking, diabetes mellitus); operation-related factors (operative time, blood loss, reoperation, instrumentation, surgical approach, number of levels operated, number of levels fused, surgical site); and season (warm, cold). In Japan, the warm season is from April to September and the cool season is from October to March.
Care Bundle
Care Bundle implementation to prevent SSI began in April 2019. Before this time, standard hospital sterilizing procedures were utilized. Standard prophylaxis is described below. All surgical procedures were performed in operating rooms maintained according to CDC guidelines
8
for infection control, including proper sterilization of instruments, environmental cleaning, use of sterile barriers, and controlled airflow system. The skin is disinfected with 10% iodine gluconate 30 minutes before the incision and washed with physiologic saline at least two or three times before and after implant insertion and once more before closing the wound. Antibacterial sutures are used for the wound closure. We also monitor the patient’s blood glucose concentrations, maintain oxygen saturation, and control the normal body temperature. Blood glucose is monitored pre-operatively and every 4 hours post-operatively for 24 hours. If concentrations exceeded 180 mg/dL, insulin therapy is initiated. Oxygen saturation is continuously monitored intra-operatively and post-operatively, with supplemental oxygen administered to maintain Peripheral capillary oxygen saturation (SpO2) ≥ 94%.8–11
In addition to these standard precautions, we developed and implemented our own Care Bundle, which we now strictly adhere to as standard peri-operative care. Our Care Bundle is outlined below.
Pre-operative treatment: Patients bathe or shower with 4% chlorhexidine gluconate once the night before operation.
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Skin disinfection: Olanexidine gluconate (1.5%) is used once 30 minutes before skin incision. For patients with hypersensitivity to olanexidine gluconate, chlorhexidine gluconate alcohol is substituted.
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Glove change: All staff involved in the surgical procedure wear double gloves and change the outer gloves every two hours during operation.
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Iodine-impregnated surgical incisional draping: Allows at least three minutes for the skin to dry before application
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; waits for the drape to dry. Appropriate prophylactic antibiotic agents (1st Cephalosporins): Cefotiam is administered as a prophylactic antibiotic, but since April 2019, patients with normal renal function have been administered 2 g of sodium cefazolin, followed by 1 g of sodium cefazolin every 2.5 hours. Vancomycin (VCM) is used in patients with impaired renal function or allergy to β-lactams.6,9,10,14 High-performance space purifier: A PLASMAIRTM (airinspace, SAS Institute Inc., France) air decontamination unit is installed in the operating room.
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Additional pre-operative skin disinfection (posterior cervical spine operation only): Sponge brushing with 10% iodine gluconate before disinfection with 1.5% olanexidine gluconate on skin. For patients with iodine hypersensitivity, iodine-free alcohol or chlorhexidine gluconate alcohol is substituted.
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For standardized peri-operative care, a checklist was used for each case, and compliance data were recorded in the electronic medical record. Nurses and surgical staff received training to ensure adherence to the protocol.
Statistical analysis
Statistical analysis software JMP® 15 (SAS Institute Inc., Cary, NC, USA) was used for data analysis and to calculate the mean, standard deviation, and frequency of demographic and clinical characteristics of the patients. Uni-variable analysis was performed to identify the factors associated with SSI occurrence. Parameters with p-values <0.1 in the uni-variable analysis were used in the multi-variable logistic regression analysis to determine the independent parameters associated with the occurrence of SSI. Adjusted odds ratios (ORs) with 95% confidence intervals (CIs) are shown, along with their respective p-values; p-Values <0.05.
Results
The incidence of SSI and its effect on Care Bundle implementation
We analyzed 764 patients who underwent spinal operation at our hospital over a seven-year period. The mean age was 69.7 ± 12.7 years, with 443 (58.0%) women and 321 (42.0%) men in the study group. The number of patients before and after the implementation of the Care Bundle was 351 and 413, respectively. Table 1 shows the characteristics of the patients before and after the implementation of the Care Bundle. There was a slight variation in the surgical site before and after the implementation of the Care Bundle but otherwise no substantial variance in gender, age, operative time, presence of instrumentation, and number of fused vertebrae. Twenty patients (2.6%) had SSI. Five cases (0.7%) had superficial SSI, and 15 (1.9%) had deep SSI (Table 2).
Characteristics of Patients’ Backgrounds Before and After the Care Bundle (N = 764)
SD = standard deviation; TLIF = transforaminal lumbar interbody fusion; PLIF = posterior lumbar interbody fusion.
Description of Surgical Site Infection Before and After the Care Bundle
p-Value <0.05 statistically significant difference.
MSSA = methicillin-sensitive staphylococcus aureus; MRSA = methicillin-resistant staphylococcus aureus; CNS = coagulase-negative staphylococci.
Related factors of SSI occurrence
The results of the uni-variable analysis of the SSI are shown in Table 3. There was a substantial decrease from 4.6% (16/351) to 1.0% (4/413) after Care Bundle implementation, with an overall relative risk reduction of 78.8% (p = 0.004). No substantial differences in patient-related factors, such as age, gender, and BMI, were found, but greater SSI rates were correlated with smoking (5.8% vs. 1.6%, p = 0.003) and diabetes mellitus (5.3% vs. 1.9%, p = 0.025). For operation-related factors, there were no substantial differences in revision surgical procedure, operative time, blood loss, the number of levels operated, or the number of fused levels, but there were substantial differences in surgical site (anterior cervical 3.4% vs. posterior cervical 7.6% vs. thoracic 1.4% vs. anterior lumbar 0% vs. posterior lumbar 2.1%, p = 0.049) and presence of instrumentation (3.6% vs. 1.1%, p = 0.039). There were no substantial differences in the occurrence of SSI with the introduction of olanexidine gluconate, changes in appropriate prophylactic antibiotic agents, pre-operative treatment, or additional treatment for cervical spine operation. There was no substantial difference between the four groups (spring, summer, fall, and winter), but there was a substantial difference between the two groups (warm and cold) (3.8% vs. 1.2%, p = 0.024).
Uni-Variable Analysis of Factors Related to Surgical Site Infection
p-Value <0.05 statistically significant difference.
SSI = surgical site infection; BMI = body mass index.
Risk factors for SSI occurrence
The SSI results in the multi-variable logistic analysis are shown in Table 4. Multi-variable logistic regression analysis showed no substantial differences in surgical site, but there were substantial differences in the presence of preventive Care Bundle implementation (adjusted OR 0.27, 95% CI 0.09–0.75, p = 0.013), presence of instrumentation (adjusted OR 3.59, 95% CI 1.07–12.0, p = 0.038), and surgical procedure in the warm season (adjusted OR 3.63, 95% CI 1.17–12.0, p = 0.025), all of which were identified as independent risk factors.
Multi-Variable Analysis of Factors Associated with Surgical Site Infection
p-value <0.05 statistically significant difference.
OR = odds ratio; CI = confidence interval.
Discussion
The SSI prevention Care Bundle for spinal operation at our hospital was developed and implemented in April 2019. We observed a reduction in SSI from 4.6% before implementation to 1.0% after implementation, amounting to a 78.8% reduction in risk. This result was achieved by applying the Care Bundle to all spinal surgical procedures. The Care Bundle remained substantial after adjusting for clinically relevant parameters in the multi-variable analysis. Previous reports showed that Care Bundle implementation reduced the risk of SSI in spinal operation by 52% 14 and reduced the risk of SSI in high-risk patients for spinal instrumentation by 82%, 10 indicating the effectiveness of a Care Bundle. Furthermore, other international reviews have reported favorable results similar to those described by Vicente-Sánchez et al. 15 As part of our Care Bundle, we introduced a high-performance space purifier 11 for sterilizing airborne bacteria. The implementation of additional sponge brushing with 10% iodine gluconate for cervical spine operation was introduced for the selective prevention of SSI after posterior cervical spine operation, which occurs frequently in our hospital. A recent study identified that Care Bundle practices, such as bathing or showering with 4% chlorhexidine gluconate before surgical procedure, hair removal, use of appropriate prophylactic antibiotic agents, hand hygiene compliance, and intra-operative glucose control, reduced the occurrence of SSI from 3.4% to 1.2%. 16 Care Bundle implementation of pre-operative bathing, use of appropriate prophylactic antibiotic agents, nasal decontamination with mupirocin, and use of VCM for instrumented surgical procedure have also been reported to reduce SSI from 4.1% to 2.0%. 14 These are the results of implementing our own unique Care Bundle; therefore, similar effects may not be achieved in all facilities. However, these results strongly suggest that SSI preventative Care Bundles, if properly implemented, can lead to clear improvements in healthcare benefits.9,10,13
In the uni-variable analysis of this study, substantial differences were found in smoking, diabetes mellitus, presence of instrumentation, surgical site (posterior cervical operation), and season (warm season). The risk factors for SSI were age, gender (male), diabetes mellitus, obesity, previous SSI, smoking, operation time, posterior approach to the spine, cervical spine operation, and multi-level operations.9,17 The reasons for the lack of substantial differences in age, operative time, and blood loss were patient and hospital characteristics. Multi-variable analysis adjusted for presence of instrumentation, surgical site (posterior cervical spine), and season (warm season) showed that implementing a Care Bundle was effective. Presence of instrumentation and seasonal factors of the warm season were independent factors in the occurrence of SSI. Although it is not possible to select most patient factors, it is possible to change the timing of surgical procedure or select an anterior–posterior approach to the surgical site. We believe that knowledge of seasonal variations in the incidence of SSI and techniques that allow a variety of approach methods are clinically important from the viewpoint of SSI prevention.
With regard to surgical site, the incidence of SSIs in cervical has been reported to be greater than that in other regions. 17 Anterior approach surgical procedure showed a lower incidence of SSI (2.3%) than posterior approach surgical procedure (5.0%). 18 In addition, the risk of infection is much greater for cervical posterior approach operation than for cervical anterior approach operation, with infection rates reported to be up to 18%. 16 However, some reports indicate that the incidence of SSI is not substantially different between surgical sites (cervical, thoracic, and lumbar spine).18,19 Our results showed that there was no substantial difference in the surgical site in the multi-variable analysis, but posterior cervical operation was more likely to cause infection. As an infection prevention measure, in posterior cervical spine operation we performed double disinfection with sponge brushing with iodine and olanexidine. The most common causes of posterior cervical spine operation include multi-level operation of the spine, high invasiveness in obese patients, and surgical factors, such as dissection of the paraspinal muscles, impaired blood flow to the tissue because of electrocautery, and dead space formation. 17
Spinal instrumentation surgical procedure has also been reported to be strongly correlated with the incidence of SSI, which is consistent with our study.17,18 The incidence of SSI is greater for posterior cervical spine operation with instrumentation than for posterior cervical decompression only, with an incidence of 1%–12%. 20 In the case of implant-related SSIs, the need for instrumentation should be carefully considered, as delayed infection may require implant removal, resulting in greater medical costs.
This study found that spring or summer in Japan (warm seasons) is associated with a greater risk of SSI after spinal operation. One retrospective study reported a greater incidence of SSI in cases that occurred during summer or fall than in winter or spring, 21 concluding that warm seasons are risk factors for SSI. 22 A recent large study reported that the incidence of SSIs was greater in July (warm season) than in other months of the year. 23 Several potential reasons for the seasonal variation in SSI incidence have been widely debated. First, the prevalence of various bacteria in the immediate environment owing to seasonal changes has been reported. Bacterial counts, such as Staphylococcus aureus and Escherichia coli, are known to increase during warm season. 24 Increased temperature and humidity during warmer seasons can lead to increased perspiration, unfavorable wound healing conditions, increased bacterial counts on human skin and in hospitals, and increased incidence of SSI.22,23 Timing of medical staff turnover is another factor that may increase the incidence of SSI. It has been reported that SSI is more common in April in our country, Japan, July in the United States, and August in the United Kingdom, which is during the job change season in each country. 7 Our study (in Japan) considered the possibility that patients with SSI conducted in spring may have been affected by an influx of inexperienced staff.
Our study had several limitations. First, this was a retrospective observational study and not a randomized controlled trial. Factors other than the Care Bundle for SSI prevention may have contributed to the reduction in SSI occurrence. And further prospective studies are needed to assess whether risk factor measures may contribute to preventing infection. Second, the number of patients with SSI was relatively small. Even if there is no change in case complexity or patient comorbidities, the increase in minimally invasive procedures over time may be responsible for reducing infection rates. The strength of this study, however, is the incorporation of data from more than 700 cases, which provides stronger evidence of the success of Care Bundle implementation.
Conclusions
Our Care Bundle was effective in preventing infections. Certain factors such as instrumentation and surgical procedures during warm seasons were associated with greater SSI rates. Although the implementation of various measures alone will not fully prevent the occurrence of SSIs, their combined use may increase the effectiveness of preventative efforts. As each hospital has its own risk factors for SSI, it is recommended that each hospital implement its own Care Bundle for SSI prevention. To further reduce the incidence of SSIs, we believe that additional Care Bundles should be added to high-risk cases in the future.
Footnotes
Acknowledgment
The authors would like to thank Ms. Marika G. Rosenfeld for her help with editing the article.
Authors’ Contributions
M.T.: Conceptualization, methodology, investigation, formal analysis, data curation, writing—original draft, writing—review and editing, and supervision. K.M.: Conceptualization, methodology, formal analysis, validation, writing—review and editing, and supervision. F.A.: Conceptualization, writing—original draft, writing—review and editing, and supervision. K.K.: Conceptualization, writing—original draft, writing—review and editing, and supervision. M.N.: Conceptualization, writing—original draft, and writing—review and editing. M.G.R.: Conceptualization, writing—original draft, and writing—review and editing. T.T.: Conceptualization, writing—original draft, writing—review and editing, and supervision.
Ethical Approval
Ethical approval was obtained from the Hyogo College of Medicine’s Institutional Ethics Committee (IRB approval no.:4054).
Author Disclosure Statement
There are no companies or organizations with conflict of interest (COI) relationships to disclose related to this publication.
Funding Information
No funds were received in support of this work.
