Does Topical Vancomycin Powder Use in Fracture Surgery Change Bacteriology and Antibiotic Susceptibilities? An Analysis of the VANCO Trial.

OBJECTIVE: To determine whether intrawound vancomycin changes the bacteriology of surgical site infection pathogens and investigate the emergence of antibiotic-resistant pathogens. DESIGN: Secondary analysis of phase III, prospective, randomized clinical trial. SETTING: Thirty-six US trauma centers. PATIENT SELECTION CRITERIA: Patients who became infected after fixation of tibial plateau or pilon fracture. OUTCOME MEASURES AND COMPARISONS: Pathogen types and bacterial susceptibilities as determined from routine clinical culture in the operating room. RESULTS: Seventy-four patients were studied who were 67.5% male with a mean age of 48.6 years. A lower proportion of gram-positive cocci was observed in the vancomycin powder compared with the standard-of-care group (3.7% vs. 8.0%, P = 0.01). Methicillin-resistant Staphylococcus aureus infection incidence was comparable in both the vancomycin powder and the standard-of-care groups, but rates of methicillin-susceptible S. aureus infections were lower in the treatment group (1.4% vs. 4.8%, P = 0.01). The incidence of coagulase-negative Staphylococci and gram-negative rod infections were similar in both groups. There was no significant difference in susceptibilities between groups in rates of vancomycin-resistant enterococcus. CONCLUSIONS: Topical vancomycin powder decreases the likelihood of gram-positive infections consistent with the biologic activity of vancomycin. Fewer methicillin-susceptible S. aureus and coagulase-negative Staphylococci infections were observed in the group treated with vancomycin powder. An effect of vancomycin powder on methicillin-resistant S. aureus infection risk was not detected given the low incidence in both the intrawound vancomycin and the standard-of-care groups. There was no emergence of gram-negative rod infections or increased resistance patterns observed. Use of topical vancomycin powder does not seem to produce infections in these patients with greater antibiotic resistance than would have occurred without its use. LEVEL OF EVIDENCE: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

Skin Antisepsis before Surgical Fixation of Extremity Fractures.

BACKGROUND: Studies evaluating surgical-site infection have had conflicting results with respect to the use of alcohol solutions containing iodine povacrylex or chlorhexidine gluconate as skin antisepsis before surgery to repair a fractured limb (i.e., an extremity fracture). METHODS: In a cluster-randomized, crossover trial at 25 hospitals in the United States and Canada, we randomly assigned hospitals to use a solution of 0.7% iodine povacrylex in 74% isopropyl alcohol (iodine group) or 2% chlorhexidine gluconate in 70% isopropyl alcohol (chlorhexidine group) as preoperative antisepsis for surgical procedures to repair extremity fractures. Every 2 months, the hospitals alternated interventions. Separate populations of patients with either open or closed fractures were enrolled and included in the analysis. The primary outcome was surgical-site infection, which included superficial incisional infection within 30 days or deep incisional or organ-space infection within 90 days. The secondary outcome was unplanned reoperation for fracture-healing complications. RESULTS: A total of 6785 patients with a closed fracture and 1700 patients with an open fracture were included in the trial. In the closed-fracture population, surgical-site infection occurred in 77 patients (2.4%) in the iodine group and in 108 patients (3.3%) in the chlorhexidine group (odds ratio, 0.74; 95% confidence interval [CI], 0.55 to 1.00; P = 0.049). In the open-fracture population, surgical-site infection occurred in 54 patients (6.5%) in the iodine group and in 60 patients (7.3%) in the chlorhexidine group (odd ratio, 0.86; 95% CI, 0.58 to 1.27; P = 0.45). The frequencies of unplanned reoperation, 1-year outcomes, and serious adverse events were similar in the two groups. CONCLUSIONS: Among patients with closed extremity fractures, skin antisepsis with iodine povacrylex in alcohol resulted in fewer surgical-site infections than antisepsis with chlorhexidine gluconate in alcohol. In patients with open fractures, the results were similar in the two groups. (Funded by the Patient-Centered Outcomes Research Institute and the Canadian Institutes of Health Research; PREPARE ClinicalTrials.gov number, NCT03523962.).

Predicting Which Species of Bacteria Will Cause an Infection After Fracture Surgery.

The aim of this study was to develop and validate risk prediction models for deep surgical site infection (SSI) caused by specific bacterial pathogens after fracture fixation. A retrospective case-control study was conducted at a level I trauma center. Fifteen candidate predictors of the bacterial pathogens in deep SSI were evaluated to develop models of bacterial risk. The study included 441 patients with orthopedic trauma with deep SSI after fracture fixation and 576 control patients. The main outcome measurement was deep SSI cultures positive for methicillin-sensitive Staphylococcus aureus (MSSA), methicillin-resistant S aureus (MRSA), gram-negative rods (GNRs), anaerobes, or polymicrobial infection within 1 year of injury. Prognostic models were developed for five bacterial pathogen outcomes. Mean area under the curve ranged from 0.70 (GNRs) to 0.74 (polymicrobial). Strong predictors of MRSA were American Society of Anesthesiologists (ASA) classification of III or greater (odds ratio [OR], 3.4; 95% CI, 1.6-8.0) and time to fixation greater than 7 days (OR, 3.4; 95% CI, 1.9-5.9). Gustilo type III fracture was the strongest predictor of MSSA (OR, 2.5; 95% CI, 1.6-3.9) and GNRs (OR, 3.4; 95% CI, 2.3-5.0). ASA classification of III or greater was the strongest predictor of polymicrobial infection (OR, 5.9; 95% CI, 2.7-15.5) and was associated with increased odds of GNRs (OR, 2.7; 95% CI, 1.5-5.5). Our models predict the risk of MRSA, MSSA, GNR, anaerobe, and polymicrobial infections in patients with fractures. The models might allow for modification of preoperative antibiotic selection based on the particular pathogen posing greatest risk for this patient population. [Orthopedics. 2024;47(1):e19-e25.].

Local administration of vancomycin powder in orthopaedic fracture surgery: current practice and trends.

Objectives: Surgical site infections in orthopaedic trauma are a significant problem with meaningful patient and health care system-level consequences. Direct application of antibiotics to the surgical field has many potential benefits in reducing surgical site infections. However, to date, the data regarding the local administration of antibiotics have been mixed. This study reports on the variability of prophylactic vancomycin powder use in orthopaedic trauma cases across 28 centers. Methods: Intrawound topical antibiotic powder use was prospectively collected within three multicenter fracture fixation trials. Fracture location, Gustilo classification, recruiting center, and surgeon information were collected. Differences in practice patterns across recruiting center and injury characteristics were tested using chi-square statistic and logistic regression. Additional stratified analyses by recruiting center and individual surgeon were performed. Results: A total of 4941 fractures were treated, and vancomycin powder was used in 1547 patients (31%) overall. Local administration of vancomycin powder was more frequent in open fractures 38.8% (738/1901) compared with closed fractures 26.6% (809/3040) (P < 0.001). However, the severity of the open fracture type did not affect the rate at which vancomycin powder was used (P = 0.11). Vancomycin powder use varied substantially across the clinical sites (P < 0.001). At the surgeon level, 75.0% used vancomycin powder in less than one-quarter of their cases. Conclusions: Prophylactic intrawound vancomycin powder remains controversial with varied support throughout the literature. This study demonstrates wide variability in its use across institutions, fracture types, and surgeons. This study highlights the opportunity for increased practice standardization for infection prophylaxis interventions. Level of Evidence: Prognostic-III.

Poor Agreement Between Next-Generation DNA Sequencing and Bacterial Cultures in Orthopaedic Trauma Procedures.

BACKGROUND: Next-generation DNA sequencing (NGS) detects bacteria-specific DNA corresponding to the 16S ribosomal RNA gene and can identify bacterial presence with greater accuracy than traditional culture methods. The clinical relevance of these findings is unknown. The purpose of the present study was to compare the results from bacterial culture and NGS in order to characterize the potential use of NGS in orthopaedic trauma patients. METHODS: A prospective cohort study was performed at a single academic, level-I trauma center. Three patient groups were enrolled: (1) patients undergoing surgical treatment of acute closed fractures (presumed to have no bacteria), (2) patients undergoing implant removal at the site of a healed fracture without infection, and (3) patients undergoing a first procedure for the treatment of a fracture nonunion who might or might not have subclinical infection. Surgical site tissue was sent for culture and NGS. The proportions of culture and NGS positivity were compared among the groups. The agreement between culture and NGS results was assessed with use of the Cohen kappa statistic. RESULTS: Bacterial cultures were positive in 9 of 111 surgical sites (110 patients), whereas NGS was positive in 27 of 111 surgical sites (110 patients). Significantly more cases were positive on NGS as compared with culture (24% vs. 8.1%; p = 0.001), primarily in the acute closed fracture group. No difference was found in terms of the percent positivity of NGS when comparing the acute closed fracture, implant removal, and nonunion groups. With respect to bacterial identification, culture and NGS agreed in 73% of cases (κ = 0.051; 95% confidence interval, -0.12 to 0.22) indicating only slight agreement compared with expected chance agreement of 50%. CONCLUSIONS: NGS identified bacterial presence more frequently than culture, but with only slight agreement between culture and NGS. It is possible that the increased frequency of bacterial detection with molecular methods is reflective of biofilm presence on metal or colonization with nonpathogenic bacteria, as culture methods have selection pressure posed by restrictive, artificial growth conditions and there are low metabolic activity and replication rates of bacteria in biofilms. Our data suggest that NGS should not currently substitute for or complement conventional culture in orthopaedic trauma cases with low suspicion of infection. LEVEL OF EVIDENCE: Diagnostic Level II. See Instructions for Authors for a complete description of levels of evidence.

Are deep infections that present before and after 90 days from orthopaedic trauma different? An analysis of the validity of the recent change in CDC criteria for infections.

BACKGROUND: In 2016, the Centers for Disease Control and Prevention (CDC) changed the time frame for their definition of deep surgical site infection (SSI) from within 1 year to within 90 days of surgery. We hypothesized that a substantial number of infections in patients who have undergone fracture fixation present beyond 90 days and that there are patient or injury factors that can predict who is more likely to present with SSI after 90 days. METHODS: A retrospective review yielded 452 deep SSI after fracture fixation. These patients were divided into two groups-those infected within 90 days of surgery and those infected beyond 90 days . Data were collected on risk factors for infection. Univariate and multiple logistic regression analyses were performed to compare the two groups. A randomly selected control group was used to build infection prediction models for both outcomes. The two outcomes were then modelled against each other to determine whether differences in predictors for early versus late infection exist. RESULTS: Of the 452 infections, 144 occurred beyond 90 days (32% [95% CI, 28%-36%]). No statistically significant patient factors were found in multivariable analysis between the early and late infection groups. The need for flap coverage was the only injury characteristic that differed significantly between groups, with patients in the late infection group more likely to have needed a flap. When modelled against the control group and directly comparing the two models, predictors for early infection include male sex and fractures of the pelvis, acetabulum, or hip, whereas predictors of late infection include hepatitis C and/or human immunodeficiency virus (HIV) and admission to the intensive care unit (ICU). CONCLUSION: Use of the recent CDC definition will underestimate the rate of actual postoperative infections when applied to orthopaedic trauma patients. Hepatitis C and/or HIV and ICU admission are predictors of late infection, whereas male sex and pelvis, acetabulum, or hip fractures are predictors of early infection. Patients who receive flap coverage may be more likely to present with late infection.

Admission Hyperglycemia Is a Risk Factor for Deep Surgical-Site Infection in Orthopaedic Trauma Patients.

OBJECTIVES: To evaluate the association of admission blood glucose ≥200 mg/dL and surgical site infection in orthopaedic trauma surgery. DESIGN: Retrospective, case control study. SETTING: Academic trauma center. PATIENTS: Four hundred sixty-five nondiabetic, noncritically ill orthopaedic trauma patients with an extremity, pelvic, or acetabular fracture and requiring open reduction and internal fixation or intramedullary nailing. INTERVENTION: None. MAIN OUTCOME MEASUREMENTS: Ninety-day deep surgical site infection. RESULTS: Admission blood glucose ≥200 mg/dL was significantly associated with the primary outcome (8/128, 6.3% vs. 35/337, 1.8%; P = 0.01). Multivariable logistic regression modeling demonstrated that admission blood glucose ≥200 mg/dL was a significant risk factor for deep surgical site infections [odds ratio (OR): 4.7, 95% confidence interval (CI) 1.4-15.7], after controlling for male gender (OR: 1.8, 95% CI: 1.1-3.1), prior drug or alcohol abuse (OR: 1.9, 95% CI 0.9-4.0), open fracture (OR: 6.4, 95% CI 3.7-11.0), and fracture region (upper extremity OR: reference; pelvis/hip OR: 3.9, 95% CI 1.6-9.7; femur OR: 2.0, 95% CI 0.88-4.8; tibia/ankle OR: 3.3, 95% CI 1.7-6.2; and foot OR: 2.7, 95% CI 1.2-6.3). CONCLUSIONS: Admission glucose ≥200 mg/dL was a significant independent risk factor for 90-day deep surgical site infections in orthopaedic trauma patients and may serve as an important marker for infection risk. LEVEL OF EVIDENCE: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

Effect of Intrawound Vancomycin Powder in Operatively Treated High-risk Tibia Fractures: A Randomized Clinical Trial.

Importance: Despite the widespread use of systemic antibiotics to prevent infections in surgically treated patients with fracture, high rates of surgical site infection persist. Objective: To examine the effect of intrawound vancomycin powder in reducing deep surgical site infections. Design, Setting, and Participants: This open-label randomized clinical trial enrolled adult patients with an operatively treated tibial plateau or pilon fracture who met the criteria for a high risk of infection from January 1, 2015, through June 30, 2017, with 12 months of follow-up (final follow-up assessments completed in April 2018) at 36 US trauma centers. Interventions: A standard infection prevention protocol with (n = 481) or without (n = 499) 1000 mg of intrawound vancomycin powder. Main Outcomes and Measures: The primary outcome was a deep surgical site infection within 182 days of definitive fracture fixation. A post hoc comparison assessed the treatment effect on gram-positive and gram-negative-only infections. Other secondary outcomes included superficial surgical site infection, nonunion, and wound dehiscence. Results: The analysis included 980 patients (mean [SD] age, 45.7 [13.7] years; 617 [63.0%] male) with 91% of the expected person-time of follow-up for the primary outcome. Within 182 days, deep surgical site infection was observed in 29 of 481 patients in the treatment group and 46 of 499 patients in the control group. The time-to-event estimated probability of deep infection by 182 days was 6.4% in the treatment group and 9.8% in the control group (risk difference, -3.4%; 95% CI, -6.9% to 0.1%; P = .06). A post hoc analysis of the effect of treatment on gram-positive (risk difference, -3.7%; 95% CI, -6.7% to -0.8%; P = .02) and gram-negative-only (risk difference, 0.3%; 95% CI, -1.6% to 2.1%; P = .78) infections found that the effect of vancomycin powder was a result of its reduction in gram-positive infections. Conclusions and Relevance: Among patients with operatively treated tibial articular fractures at a high risk of infection, intrawound vancomycin powder at the time of definitive fracture fixation reduced the risk of a gram-positive deep surgical site infection, consistent with the activity of vancomycin. Trial Registration: ClinicalTrials.gov Identifier: NCT02227446.

Evaluation of Intra-Operative Topical Vancomycin and the Incidence of Acute Kidney Injury.

Background: Intra-operative topical vancomycin (VAN) is a strategy used to prevent surgical site infections (SSI). Although evidence supporting efficacy in SSI prevention is evolving, data describing safety, specifically acute kidney injury (AKI), are limited. The purpose of this study was to determine AKI incidence in patients who received intra-operative topical VAN. Patients and Methods: This is a retrospective study of adult inpatient encounters in which topical VAN was administered intra-operatively as powder/paste, beads, rods/cement/spacers, or unspecified topical route from February to July 2018. Patients were excluded for AKI or renal replacement therapy (RRT) at baseline or ≤2 serum creatinine (SCr) values post-surgery. The primary outcome was AKI incidence after intra-operative topical VAN, defined as increase in SCr ≥50% or 0.5 mg/dL from baseline or RRT initiation. Secondary outcomes included analysis of AKI risk factors and SSI incidence. Acute kidney injury risk factors were analyzed using multivariable logistic regression. Results: Five hundred thirty-four patient encounters met study criteria. Powder/paste were the most common topical VAN formulations (44.8%) with median doses of 2,000 (range, 1,000-26,000) mg. Acute kidney injury incidence was 8.8%. Independent risk factors for AKI were higher Charlson comorbidity index (adjusted odds ratio [aOR], 1.20 [range, 1.06-1.36]), concomitant systemic VAN (aOR, 2.44 [range, 1.29-4.58]), and doubling of total topical VAN dose (aOR, 1.51 [range, 1.13-2.03]). Conclusions: The incidence of AKI with intra-operative topical VAN is comparable to reported rates as systemic VAN. Clinicians may consider total topical VAN dose and concomitant systemic VAN to limit AKI incidence with topical VAN use.

Low Adherence to Recommended Guidelines for Open Fracture Antibiotic Prophylaxis.

BACKGROUND: Prompt administration of antibiotics is a critical component of open fracture treatment. Traditional antibiotic recommendations have been a first-generation cephalosporin for Gustilo Type-I and Type-II open fractures, with the addition of an aminoglycoside for Type-III fractures and penicillin for soil contamination. However, concerns over changing bacterial patterns and the side effects of aminoglycosides have led to interest in other regimens. The purpose of the present study was to describe the adherence to current prophylactic antibiotic guidelines. METHODS: We evaluated the antibiotic-prescribing practices of 24 centers in the U.S. and Canada that were participating in 2 randomized controlled trials of skin-preparation solutions for open fractures. A total of 1,234 patients were evaluated. RESULTS: All patients received antibiotics on the day of admission. The most commonly prescribed antibiotic regimen was cefazolin monotherapy (53.6%). Among patients with Type-I and Type-II fractures, there was 61.1% compliance with cefazolin monotherapy. In contrast, only 17.2% of patients with Type-III fractures received the recommended cefazolin and aminoglycoside therapy, with an additional 6.7% receiving piperacillin/tazobactam. CONCLUSIONS: There is moderate adherence to the traditional antibiotic treatment guidelines for Gustilo Type-I and Type-II fractures and low adherence for Type-III fractures. Given the divergence between current practice patterns and prior recommendations, high-quality studies are needed to determine the most appropriate prophylactic protocol.

Systemic Absorption and Nephrotoxicity Associated With Topical Vancomycin Powder for Fracture Surgery.

OBJECTIVES: To determine whether using topical vancomycin powder in fracture surgery may result in low levels of vancomycin in the serum and not result in nephrotoxicity. DESIGN: Prospective observational at a single site as a substudy of the VANCO trial. SETTING: Single, large urban level I trauma center. PATIENTS/PARTICIPANTS: Fifty-eight patients with tibial plateau and pilon fractures randomized to the treatment arm at the principal investigator's site. INTERVENTION: Topical vancomycin powder (1000 mg) applied directly in the wound over all metal implants at the time of wound closure. MAIN OUTCOME MEASUREMENTS: Serum vancomycin levels at 1 hour and 6-8 hours after surgery. Secondary outcomes included serum creatinine before surgery, a day after surgery, and at 2 weeks postoperatively and complete blood count at 2 weeks postoperatively. RESULTS: Except in 2 patients who also received intravenous vancomycin, none of the study patients had detectable (>5 µg/mL) serum vancomycin levels at 1 hour and 6-8 hours after surgery. One patient with a history of elevation of serum creatinine had a minor increase of serum creatinine but had undetectable vancomycin levels. None of the other patients had a clinically significant increase in creatinine levels. CONCLUSIONS: Despite its relatively widespread usage, little data exist regarding the systemic levels and nephrotoxicity associated with the topical use of vancomycin powder in orthopaedic fracture surgery. These prospective data indicate that there seems to be little clinical concern regarding toxicity associated with systemic absorption of vancomycin powder in this specific clinical application. LEVEL OF EVIDENCE: Therapeutic Level IV. See instructions for authors for a complete description of levels of evidence.

Topical Vancomycin Powder Decreases the Proportion of Staphylococcus aureus Found in Culture of Surgical Site Infections in Operatively Treated Fractures.

OBJECTIVES: To determine whether patients with operatively treated fractures and surgical site infection after use of topical vancomycin powder have a lower proportion of Staphylococcus aureus infections than patients who did not receive topical vancomycin powder. DESIGN: Retrospective cohort study. SETTING: Level I trauma center. PATIENTS: Treatment group: 10 of 133 patients (145 fractures) with surgical site infections who received intrawound vancomycin powder at the time of wound closure for fracture fixation. Control group: 175 patients who sustained deep surgical site infections during the same period but did not receive vancomycin powder. INTERVENTION: Vancomycin powder or no vancomycin powder. MAIN OUTCOME MEASUREMENT: Proportion of patients' cultures positive for S. aureus. RESULTS: The proportion of cultures positive for S. aureus was significantly lower in patients with surgical site infection who received vancomycin powder than in those who did not receive vancomycin powder (10% [1 of 10 patients in the treatment group] vs. 50% [87 of 175 patients in the control group]; P = 0.02). A trend was observed for a lower proportion of methicillin-resistant S. aureus (0% vs. 23%; P = 0.12). CONCLUSIONS: Vancomycin powder might alter the bacteriology of surgical site infections and decrease the proportion in culture of the most common organism typically present after fracture surgery infection. These findings suggest that the application of vancomycin powder might change the bacteriology of surgical site infections when they occur, regardless of the effect on overall infection rates. Although our bacteriology results are clinically and statistically significant, these findings must be confirmed in larger randomized controlled trials. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Effectiveness of Iodophor vs Chlorhexidine Solutions for Surgical Site Infections and Unplanned Reoperations for Patients Who Underwent Fracture Repair: The PREP-IT Master Protocol.

Importance: The risk of developing a surgical site infection after extremity fracture repair is nearly 5 times greater than in most elective orthopedic surgical procedures. For all surgical procedures, it is standard practice to prepare the operative site with an antiseptic solution; however, there is limited evidence to guide the choice of solution used for orthopedic fracture repair. Objective: To compare the effectiveness of iodophor vs chlorhexidine solutions to reduce surgical site infections and unplanned fracture-related reoperations for patients who underwent fracture repair. Design, Setting, and Participants: The PREP-IT (Program of Randomized Trials to Evaluate Pre-operative Antiseptic Skin Solutions in Orthopaedic Trauma) master protocol will be followed to conduct 2 multicenter pragmatic cluster randomized crossover trials, Aqueous-PREP (Pragmatic Randomized Trial Evaluating Pre-Operative Aqueous Antiseptic Skin Solution in Open Fractures) and PREPARE (Pragmatic Randomized Trial Evaluating Pre-Operative Alcohol Skin Solutions in Fractured Extremities). The Aqueous-PREP trial will compare 4% aqueous chlorhexidine vs 10% povidone-iodine for patients with open extremity fractures. The PREPARE trial will compare 2% chlorhexidine in 70% isopropyl alcohol vs 0.7% iodine povacrylex in 74% isopropyl alcohol for patients with open extremity fractures and patients with closed lower extremity or pelvic fractures. Both trials will share key aspects of study design and trial infrastructure. The studies will follow a pragmatic cluster randomized crossover design with alternating treatment periods of approximately 2 months. The primary outcome will be surgical site infection and the secondary outcome will be unplanned fracture-related reoperations within 12 months. The Aqueous-PREP trial will enroll a minimum of 1540 patients with open extremity fractures from at least 12 hospitals; PREPARE will enroll a minimum of 1540 patients with open extremity fractures and 6280 patients with closed lower extremity and pelvic fractures from at least 18 hospitals. The primary analyses will adhere to the intention-to-treat principle and account for potential between-cluster and between-period variability. The patient-centered design, implementation, and dissemination of results are guided by a multidisciplinary team that includes 3 patients and other relevant stakeholders. Discussion: The PREP-IT master protocol increases efficiency through shared trial infrastructure and study design components. Because prophylactic skin antisepsis is used prior to all surgical procedures and the application, cost, and availability of all study solutions are similar, the results of the PREP-IT trials are poised to inform clinical guidelines and bring about an immediate change in clinical practice. Trial Registration: ClinicalTrials.gov Identifiers: NCT03385304 and NCT03523962.

A Predictive Score for Determining Risk of Surgical Site Infection After Orthopaedic Trauma Surgery.

OBJECTIVES: To determine factors predictive of postoperative surgical site infection (SSI) after fracture fixation and create a prediction score for risk of infection at time of initial treatment. DESIGN: Retrospective cohort study. SETTING: Level I trauma center. PATIENTS/PARTICIPANTS: Study group, 311 patients with deep SSI; control group, 608 patients. INTERVENTION: We evaluated 27 factors theorized to be associated with postoperative infection. Bivariate and multiple logistic regression analyses were used to build a prediction model. A composite score reflecting risk of SSI was then created. MAIN OUTCOME MEASURES: Risk of postoperative infection. RESULTS: The final model consisted of 8 independent predictors: (1) male sex, (2) obesity (body mass index ≥ 30) (3) diabetes, (4) alcohol abuse, (5) fracture region, (6) Gustilo-Anderson type III open fracture, (7) methicillin-resistant Staphylococcus aureus nasal swab testing (not tested or positive result), and (8) American Society of Anesthesiologists classification. Risk strata were well correlated with observed proportion of SSI and resulted in a percent risk of infection of 1% for ≤3 points, 6% for 4-5 points, 11% for 6 to 8-9 points, and 41% for ≥10 points. CONCLUSION: The proposed postoperative infection prediction model might be able to determine which patients have fractures at higher risk of infection and provides an estimate of the percent risk of infection before fixation. LEVEL OF EVIDENCE: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

Variations in the Organisms Causing Deep Surgical Site Infections in Fracture Patients at a Level I Trauma Center (2006-2015).

OBJECTIVES: To quantify the current bacteriology of deep surgical site infections (SSIs) after fracture surgery at 1 institution and to compare those data with historical controls at the same institution, assessing variations in infecting organisms over the past decade. DESIGN: Retrospective review. SETTING: Level I trauma center. PATIENTS/PARTICIPANTS: Two hundred forty-three patients requiring surgical intervention for deep SSI between January 2011 and December 2015 were compared with 211 patients requiring surgical intervention for deep SSI between December 2006 and December 2010. INTERVENTION: None. MAIN OUTCOME MEASUREMENTS: Bacteria were categorized as Staphylococcus aureus, coagulase-negative staphylococci (CoNS), Streptococcus, Enterococcus, gram-negative rods (GNR), gram-positive rods, anaerobes, or negative cultures. The proportion of each bacterial type was determined and compared with previously published data from the same trauma center (December 2006 to December 2010). RESULTS: Patients most commonly had S. aureus infections (48%), followed by GNR (40%) and CoNS (19%). The proportion of CoNS species (26% vs. 12%, P < 0.01) in infected patients was significantly higher during the current study period compared with historical controls. The proportion of S. aureus species in infected patients was significantly less during the current study period (39% vs. 56%, P < 0.01). The reduction in the proportion of S. aureus species in infected patients was driven by a decrease in the proportion of methicillin-resistant S. aureus (MRSA) in the overall sample. CONCLUSIONS: Bacteriology of deep SSI of fractures has changed substantially over the past decade at our center, specifically the proportions of GNR, CoNS, and MRSA. LEVEL OF EVIDENCE: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

Intraoperative Vancomycin Powder Reduces Staphylococcus aureus Surgical Site Infections and Biofilm Formation on Fixation Implants in a Rabbit Model.

OBJECTIVES: To evaluate the effectiveness of intraoperative vancomycin powder in prevention of surgical site infection and biofilm formation on implants in a contaminated animal fixation model. METHODS: We created a rabbit surgical model including fixation implants at a tibial surgical site seeded with methicillin-resistant Staphylococcus aureus. Our study cohort included 18 rabbits. Nine received vancomycin powder at the surgical site, and the other 9 did not. Serum vancomycin levels were measured at scheduled time points over 24 hours. Bone infection and implant biofilm formation were determined based on the number of colony-forming units present 2 weeks after surgery. Radiography, histology, and electron microscopy aided in evaluation. RESULTS: No bone infection or implant colonization occurred in the vancomycin powder group. Six bone infections and 6 implant biofilm formations (67%; 95% confidence interval, 45%-88%) occurred in the group that did not receive vancomycin powder (P = 0.009). Serum vancomycin levels were detectable at minimal levels at 1 and 6 hours only. Pathological changes occurred in the specimens that were positive for infection. CONCLUSIONS: Intraoperative vancomycin powder application at the time of fixation decreases risk for bone infection and biofilm formation on implants in a rabbit model, with minimal increase in serum vancomycin levels. The results are encouraging and support the rationale for a clinical trial investigating the use of local vancomycin powder to reduce the rate of surgical site infections. CLINICAL RELEVANCE: Infection is a common complication of surgery, especially with implants. Simple methods to prevent or decrease the occurrence of infection would benefit the patient and the health care system.

Less is more? Antibiotic duration and outcomes in Fournier's gangrene.

BACKGROUND: Antibiotic management of Fournier's gangrene (FG) is without evidence-based guidelines and is based on expert opinion. The effect of duration of antibiotic therapy on outcomes in FG is unknown. METHODS: A retrospective review was performed of FG patients from 2012 to 2015 at a single institution. Patients were managed by our institutional practice of complete primary wound closure as possible, with antibiotic duration according to physician judgment. Patients were stratified into multiple durations of antibiotic administration. RESULTS: Overall, 168 patients with FG were included. When examining multiple stratifications of antibiotic therapy of 7 days or less, 8 days to 10 days, 11 days to 14 days, or 15 days or more of antibiotics, there was no significant difference in mortality (p = 0.11), primary closure (p = 0.75), surgical site infection (SSI) (p = 0.52), or Clostridium difficile infection (p = 0.63). There were no cases of recurrent FG in any antibiotic stratification. Mortality was not increased (p = 1.00) and ability to achieve primary closure was not decreased (p = 0.08) with initial antibiotic therapy exclusive of cultured organisms. CONCLUSION: Shorter antibiotic courses for patients in whom source control is obtained and initial antibiotic selection exclusive of many resistant organisms were not associated with worse outcomes in FG. LEVEL OF EVIDENCE: Therapeutic, level IV.

Supplemental Perioperative Oxygen to Reduce Surgical Site Infection After High-Energy Fracture Surgery (OXYGEN Study).

Supplemental perioperative oxygen (SPO) therapy has been proposed as one approach for reducing the risk of surgical site infection (SSI). Current data are mixed regarding efficacy in decreasing SSI rates and hospital inpatient stays in general and few data exist for orthopaedic trauma patients. This study is a phase III, double-blind, prospective randomized clinical trial with a primary goal of assessing the efficacy of 2 different concentrations of perioperative oxygen in the prevention of SSIs in adults with tibial plateau, pilon (tibial plafond), or calcaneus fractures at higher risk of infection and definitively treated with plate and screw fixation. Patients are block randomized (within center) in a 1:1 ratio to either treatment group (FiO2 80%) or control group (FiO2 30%) and stratified by each study injury location. Secondary objectives of the study are to compare species and antibacterial sensitivities of the bacteria in patients who develop SSIs, to validate a previously developed risk prediction model for the development of SSI after fracture surgery, and to measure and compare resource utilization and cost associated with SSI in the 2 study groups. SPO is a low cost and readily available resource that could be easily disseminated to trauma centers across the country and the world if proved to be effective.

Local Antibiotic Therapy to Reduce Infection After Operative Treatment of Fractures at High Risk of Infection: A Multicenter, Randomized, Controlled Trial (VANCO Study).

A number of clinical studies in the spine literature suggest that the use of local vancomycin powder may substantially reduce surgical site infections (SSIs). These studies are primarily retrospective and observational and few focus on orthopaedic trauma patients. This study is a phase III, prospective, randomized, clinical trial to assess the efficacy of locally administered vancomycin powder in the prevention of SSI after fracture surgery. The primary goal of the VANCO Study is to compare the proportion of deep SSI 6 months after fracture fixation surgery. A secondary objective is to compare species and antibacterial susceptibilities among study patients who develop SSI. An additional objective is to build and validate a risk prediction model for the development of SSI. The study population consists of patients aged 18-80 years with tibial plateau or pilon (tibial plafond) fractures, at higher risk of infection, and definitively treated with plate and screw fixation. Participants are block randomized (within center) in a 1:1 ratio to either treatment group (local vancomycin powder up to a maximum dose of 1000 mg, placed immediately before wound closure) or control group (standard of care) for each study injury location, and return to the clinic for evaluations at 2 weeks, 3 months, and 6 months after fixation. The targeted sample size for the study is 500 fractures per study arm. This study should provide important information regarding the use of local vancomycin powder during the definitive treatment of lower extremity fractures and has the potential to significantly reduce the incidence of infection after orthopaedic trauma.

Acute Transverse Myelitis Associated with Salmonella Bacteremia: A Case Report.

BACKGROUND Acute transverse myelitis (ATM) is an uncommon and often overlooked complication of certain bacterial and viral infections that can have a rapid onset and result in severe neurological deficits.  CASE REPORT This case report describes a previously healthy 28-year-old woman who presented to the trauma center after developing acute paralysis and paresthesias of all four extremities within the span of hours. The initial presumptive diagnosis was spinal cord contusion due to a fall versus an unknown mechanism of trauma, but eventual laboratory studies revealed Salmonella bacteremia, indicating a probable diagnosis of parainfectious ATM. CONCLUSIONS This case illustrates the importance of considering the diagnosis of parainfectious ATM in patients presenting with acute paralysis with incomplete or unobtainable medical histories.