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Cost-Effectiveness Analysis of the Prophylactic Use of Ertapenem for the Prevention of Surgical Site Infections after Elective Colorectal Surgery.

ABSTRACT: Standard surgical antimicrobial prophylaxis (SAP) regimens are less effective in preventing surgical site infections (SSIs) due to rising antimicrobial resistance (AMR) rates, particularly for patients undergoing colorectal surgery. This study aimed to evaluate whether ertapenem should be a preferred strategy for the prevention of SSIs following elective colorectal surgery compared to three standard SAP regimens: amoxicillin-clavulanate, cefoxitin, and cefazolin plus metronidazole. A cost-effectiveness analysis was conducted using decision tree models. Probabilities of SSIs and AMR-SSIs, costs, and effects (in terms of quality-adjusted life-years) were considered in the assessment of the alternative strategies. Input parameters integrated real data from the Italian surveillance system for SSIs with data from the published literature. A sensitivity analysis was conducted to assess the potential impact of the decreasing efficacy of standard SAP regimens in preventing SSIs. According to our models, ertapenem was the most cost-effective strategy only when compared to amoxicillin-clavulanate, but it did not prove to be superior to cefoxitin and cefazolin plus metronidazole. The sensitivity analysis found ertapenem would be the most cost-effective strategy compared to these agents if their failure rate was more than doubled. The findings of this study suggest ertapenem should not be a preferred strategy for SAP in elective colorectal surgery.

SUBMITTER: Vicentini C

PROVIDER: S-EPMC7999678 | biostudies-literature | 2021 Mar

REPOSITORIES: biostudies-literature

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Cost-Effectiveness Analysis of the Prophylactic Use of Ertapenem for the Prevention of Surgical Site Infections after Elective Colorectal Surgery.

Vicentini Costanza C Gianino Maria Michela MM Corradi Alessio A Marengo Noemi N Bordino Valerio V Corcione Silvia S De Rosa Francesco Giuseppe FG Fattore Giovanni G Zotti Carla Maria CM

Antibiotics (Basel, Switzerland) 20210304 3

Standard surgical antimicrobial prophylaxis (SAP) regimens are less effective in preventing surgical site infections (SSIs) due to rising antimicrobial resistance (AMR) rates, particularly for patients undergoing colorectal surgery. This study aimed to evaluate whether ertapenem should be a preferred strategy for the prevention of SSIs following elective colorectal surgery compared to three standard SAP regimens: amoxicillin-clavulanate, cefoxitin, and cefazolin plus metronidazole. A cost-effect ...[more]

PMID: 33806477

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Project description:BackgroundSurgical site infections (SSIs) after elective orthopaedic surgery are very stressful for patients due to frequent rehospitalizations with reoperations and poorer functional outcomes. Prevention of such events is therefore crucial. Although an evidence-based consensus is still lacking, preoperative decolonization could decrease SSI. Specifically, more information is needed about the effect of a preoperative decolonization procedure on SSI proportions in both Staphylococcus aureus carriers and non-S. aureus carriers after general orthopaedic surgery.Questions/purposesOur study addressed the following questions: (1) Does preoperative decolonization reduce the risk of SSI after general elective orthopaedic surgery in patients colonized with S. aureus? (2) Does preoperative decolonization reduce the risk of SSI among patients who are not colonized with S. aureus?MethodsIn this prospective, randomized, single-blinded trial, we recruited patients undergoing general elective orthopaedic surgery in one tertiary care center in Switzerland. Between November 2014 and September 2017, 1318 of 1897 screened patients were enrolled. Patients were allocated into either the S. aureus carrier group (35%, 465 of 1318 patients) or the noncarrier group (65%, 853 of 1318 patients) according to screening culture results. In the S. aureus group, 232 patients were allocated to the intervention arm and 233 were allocated to the control arm. Intervention was 5 days of daily chlorhexidine showers and mupirocin nasal ointment twice a day. Of the 853 noncarriers, 426 were allocated to the intervention arm and 427 were allocated to the control arm. All patients in both groups were analyzed in an intention-to-treat manner. The primary endpoint was SSI occurrence at 90 days postoperative and the secondary endpoint was SSI occurrence at 30 days postoperative.The initial sample size calculation was made for the S. aureus carrier group. Based on the literature review, a 4% proportion of SSI was expected in the control group. Thus, 726 carriers would have been needed to detect a relative risk reduction of 80% with a power of 80% at a two-sided α-error of 0.048 (adjusted for interim analysis). Assuming carrier prevalence of 27%, 2690 patients would have been needed in total. An interim analysis was performed after including half of the targeted S. aureus carriers (363 of 726). Based on the low infection rate in the control group (one of 179), a new sample size of 15,000 patients would have been needed. This was deemed not feasible and the trial was stopped prematurely.ResultsAmong carriers, there was no difference in the risk of SSI between the intervention and control arms (decolonized SSI risk: 0.4% [one of 232], control SSI risk: 0.4% [one of 233], risk difference: 0.0% [95% CI -1.2% to 1.2%], stratified for randomization stratification factors; p > 0.999). For noncarriers, there was no difference in risk between the intervention and control arms (decolonized SSI risk: 0.2% [one of 426], control SSI risk: 0.2% [one of 247], stratified risk difference: -0.0% [95% CI -0.7 to 0.6]; p = 0.973).ConclusionsWe found no difference in the risk of SSI between the decolonization and control groups, both in S. aureus carriers and noncarriers. Because of the low event numbers, no definite conclusion about efficacy of routine preoperative decolonization can be drawn. The results, however, may be helpful in future meta-analyses.Level of evidenceLevel II, therapeutic study.

Project description:BackgroundThe application of antiseptic skin agents prior to incision minimizes the rate of surgical site infection. Despite their ubiquity, the optimal skin preparation agent remains uncertain. A retrospective economic analysis was conducted to complement the results from the NEWSkin Prep trial which prospectively compared three preparation agents.MethodsA cost and cost-effectiveness analysis was performed from a healthcare service perspective to compare chlorhexidine with 70% ethanol, and aqueous povidone-iodine, against povidone-iodine with 70% ethanol. Resource use estimates accounted for hospital admissions, readmissions associated with surgical site infection, outpatient and general practitioner attendances, visits from community nurses and therapeutic consumables. The measure of effectiveness comprised the net difference in number of patients with surgical site infections per 1000 patients. Costs were compared using a two-sample Welch's t-test. Deterministic and probabilistic sensitivity analyses were performed to evaluate the incremental cost-effectiveness ratio.ResultsThe null hypothesis that the mean costs for the trial arms were significantly different was not rejected (Welch's t-test P value: 0.771 for chlorhexidine with 70% ethanol against povidone-iodine with 70% ethanol; and 0.955 for aqueous povidone-iodine against povidone-iodine with 70% ethanol). Based on bootstrap averages, the chlorhexidine with 70% ethanol intervention generated 8.0 fewer surgical site infections per 1000 patients and net cost savings of €151,698 (Euros) per 1000 patients compared with povidone-iodine with 70% ethanol, and aqueous povidone-iodine produced a net cost saving of €37,494 per 1000 patients but generated an additional 11.6 surgical site infections per 1000 patients compared with povidone-iodine with 70% ethanol. The comparison of chlorhexidine with 70% ethanol to povidone-iodine with 70% ethanol was sensitive to the inclusion of cost outliers, while the comparison of aqueous povidone-iodine to povidone-iodine with 70% ethanol was sensitive to the estimated cost per surgical site infection.ConclusionBased on the outcomes from the NEWSkin Prep study, this economic analysis found no definitive evidence in favour of any one of the study comparators. Future model-based economic analyses of alternative skin preparations should critically address the quality of evidence and integrate the results from the NEWSkin Prep study.

Project description:OBJECTIVE:To examine the rate of surgical site infection according to the choice of antibiotics in women undergoing cesarean delivery. METHODS:We conducted a retrospective cohort study of women undergoing cesarean delivery (labored, unlabored, and scheduled) from 2012 to 2017. Women with chorioamnionitis and those who did not receive any antibiotics were excluded. Our primary outcome was defined a priori as a composite of cellulitis, endometritis, deep wound infection, abdominopelvic abscess, and sepsis. Outcomes were examined according to the choice of antibiotics: cefazolin, a standard alternative (both clindamycin and gentamicin), and inappropriate alternatives (such as clindamycin only). A multivariable logistic regression model was used to calculate the propensity score for each observation, which was the probability of receiving a particular antibiotic regimen. The propensity score-adjusted logistic regression models were conducted to calculate adjusted odds ratios (ORs) and 95% CIs. Firth's penalized likelihood approach was applied to address issues of rare events. RESULTS:Among 6,584 selected women, 6,163 (93.6%), 274 (4.2%), and 147 (2.2%) received cefazolin, a standard alternative, and inappropriate alternatives, respectively. Use of standard alternative antibiotics compared with cefazolin was not associated with increased odds of the primary outcome (crude OR 1.50 [0.92-2.46]; adjusted OR 1.63 [0.97-2.60]) but was associated with increased odds of cellulitis (crude OR 2.07 [1.16-3.70]; adjusted OR 1.93 [1.03-3.31]). Use of inappropriate alternative antibiotics compared with cefazolin was associated with increased odds of the primary outcome (crude OR 4.37 [2.80-6.83]; adjusted OR 4.13 [2.59-6.36]) as well as some components of the composite outcome such as endometritis before discharge (crude OR 6.85 [3.94-11.90]; adjusted OR 6.68 [3.69-11.44]) and cellulitis (crude OR 3.36 [1.78-6.34]; adjusted OR 3.23 [1.63-5.81]). CONCLUSION:Both standard alternative and inappropriate alternatives were associated with increased odds of surgical site infections compared with cefazolin.

Project description:BackgroundPreoperative treatment with oral neomycin combined with erythromycin or metronidazole is recommended to decrease the risk of surgical site infections (SSIs) in elective colorectal surgery. However, oral neomycin is not commercially available in Canada, and therefore it is not routinely used. Fluoroquinolones are widely available and have excellent activity against aerobic Gram-negative bacteria. The aim of this systematic review was to identify, critically appraise and summarize the evidence on the efficacy and safety of preoperative use of oral fluoroquinolone antibiotics for the prevention of SSIs in adult patients undergoing elective colorectal resection.MethodsFollowing Cochrane guidelines, we included English-language randomized controlled trials (RCTs) comparing oral fluoroquinolones plus routine preoperative intravenous antibiotics against intravenous antibiotics alone from MEDLINE (Ovid), Embase (Ovid), the Cochrane Central Register of Controlled Trials( Ovid) and ClinicalTrials.gov.ResultsWe included 3 RCTs (1136 patients). Risk of bias was uncertain in 2 trials and high in 1 trial. Preoperative oral fluoroquinolones led to significantly decreased total SSIs (risk ratio [RR] 0.43, 95% confidence interval [CI] 0.32-0.57, I 2 = 0%), superficial incisional (RR 0.38, 95% CI 0.22-0.68, I 2 = 32%), deep incisional (RR 0.19, 95% CI 0.06-0.65, I 2 = 0%) and organ/space SSIs (RR 0.34, 95% CI 0.12-0.90, I 2 = 33%). There was also a significant reduction in anastomotic leaks (RR 0.22, 95% CI 0.06-0.87, I 2 = 0%). No antibiotic-related adverse events were reported.ConclusionThis review suggests that preoperative oral fluoroquinolones with intravenous antibiotics are superior to intravenous antibiotics alone for preventing SSIs after colorectal surgery. If neomycin is unavailable, oral fluoroquinolones should be considered as a reasonable alternative. Future trials are required to further compare the relative efficacy of oral antibiotic regimens.

Project description:IntroductionSurgical site infections (SSI) are a common postoperative complication. During the development of the new WHO guidelines on SSI prevention, also in the Netherlands was concluded that perioperative care could be optimised beyond the current standard practice. We selected a limited set of readily available, cheap and evidence-based interventions from these new guidelines that are not part of standard practice in the Netherlands and formulated an Enhanced PeriOperative Care and Health bundle (EPOCH). Here, we describe the protocol for an open-label, randomised controlled, parallel-group, superiority trial to test the effect of the EPOCH bundle added to (national) standard care in comparison to standard care alone on the incidence of SSI.Methods and analysisEPOCH consists of intraoperative high fractional inspired oxygen (0.80); goal-directed fluid therapy; active preoperative, intraoperative and postoperative warming; perioperative glucose control and treatment of severe hyperglycaemia (>10 mmoll-1) and standardised surgical site handling. Patients scheduled for elective abdominal surgery with an incision larger than 5 cm are eligible for inclusion. Participants are randomised daily, 1:1 according to variable block sizes, and stratified per participating centre to either EPOCH added to standard care or standard care only. The primary endpoint will be SSI incidence according to the Centers for Disease Control and Prevention (CDC) definition within 30 days as part of routine clinical follow-up. Four additional questionnaires will be sent out over the course of 90 days to capture disability and costs. Other secondary endpoints include anastomotic leakage, incidence of incisional hernia, serious adverse events, hospital readmissions, length of stay and cost effectiveness. Analysis of the primary endpoint will be on an intention-to-treat basis.Ethics and disseminationEthics approval is granted by the Amsterdam UMC Medical Ethics Committee (reference 2015_121). Results will be disseminated through peer-reviewed journals and summaries shared with stakeholders. This protocol is published before analysis of the results.Trial registration numberRegistered in the Dutch Trial Register: NL5572.

Dataset Information

Cost-Effectiveness Analysis of the Prophylactic Use of Ertapenem for the Prevention of Surgical Site Infections after Elective Colorectal Surgery.

Publications

Cost-Effectiveness Analysis of the Prophylactic Use of Ertapenem for the Prevention of Surgical Site Infections after Elective Colorectal Surgery.

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