Prophylaxis In Surgical Patients Research Articles

Need for a targeted perioperative antibiotic treatment protocol for patients with preoperative biliary drainage undergoing pancreaticoduodenectomy

PurposeTo evaluate the bacterobilia in patients undergoing pancreaticoduodenectomy (PD) based on whether they carry a preoperative biliary drainage or not and to analyse if a targeted perioperative antibiotic treatment based on the expected microbiology leads in no differences in Surgical Site Infections (SSI) between the groups. MethodsRetrospective observational single-center study of patients undergoing pancreaticoduodenectomy with preoperative biliary stent (group P, Prosthesis) and without stent (group NP, No Prosthesis). Postoperative complications including SSI and its subtypes were analyzed after applying a targeted perioperative antibiotic treatment protocol with cefotaxime and metronidazole (group NP) and piperacillin-tazobactam (group P). ResultsBetween January 2014 and December 2021, 127 patients were treated (84 in group NP and 43 in group P). Intraoperative cultures were positive in 16.7% (group NP) vs 76.7% (group P, p < 0.01). Microorganisms isolated in group NP included Enterobacterales (10.7%) and Enterococcus spp. (7.1%) with no Candida detected. In group P: Enterobacterales (51.2%), Enterococcus spp. (48.8%), and Candida (16.3%) were higher (p < 0.01%). No differences in morbidity and mortality were observed between the groups. SSI rate was 17.8% in group NP and 23.2% in group P (ns). ConclusionBacterobilia differs in patients with biliary drainage, showing a higher presence of Enterobacterales, Enterococcus spp., and Candida. There were no differences in SSI incidence after applying perioperative antibiotic treatment tailored to the expected microorganisms in each group. This raises the need to reconsider conventional surgical prophylaxis in patients with biliary stent.

ANTIBIOTIC PROPHYLAXIS IN UROLOGIC PROCEDURE : A COMPREHENSIVE SYSTEMATIC REVIEW

Background: Antibiotics are synthetic molecules that can destroy or inhibit the growth of microorganisms without harming the host. They can be used for prophylactic purposes to reduce the incidence of postoperative infection of which duration should not exceed 24hrs in many procedures given one hour prior to incision. Also antibiotics for treatment purposes are given when an established infection has been identified. Urologists commonly prescribe antimicrobial agents before, during, and after urologic procedures. The aim: This study aims to show about antibiotic prophylaxis in urologic procedure. Methods: By comparing itself to the standards set by the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) 2020, this study was able to show that it met all of the requirements. So, the experts were able to make sure that the study was as up-to-date as it was possible to be. For this search approach, publications that came out between 2014 and 2024 were taken into account. Several different online reference sources, like Pubmed and SagePub, were used to do this. It was decided not to take into account review pieces, works that had already been published, or works that were only half done. Result: In the PubMed database, the results of our search brought up 34 articles, whereas the results of our search on SagePub brought up 77 articles. The results of the search conducted for the last year of 2014 yielded a total 26 articles for PubMed and 55 articles for SagePub. The result from title screening, a total 16 articles for PubMed and 25 articles for SagePub. In the end, we compiled a total of 10 papers. We included five research that met the criteria. Conclusion: Antibiotic therapy should be considered only for procedures in which studies have shown a clinical benefit in the prevention of infection. It is important to establish the duration and type of treatment for antimicrobial therapy for surgical prophylaxis in patients with AB who are going to receive urological invasive procedures.

Impact of the 4th of August Beirut explosion mass casualty incident on a university hospital microbial Flora

BackgroundFollowing the Beirut explosion, our university hospital received at least 350 casualties. Subsequently, infection control standard practices were compromised. Concerns for Multi-Drug Resistant Organisms (MDROs) infections in injured patients and a resulting hospital outbreak were raised. The objectives of the study were to compare the rate of hospital growing MDROs 6 months before and 6 months after the Beirut explosion, to identify emerging microorganisms and to evaluate the change in surgical infection prevention practices.MethodsThis is a retrospective chart review of patients with hospital acquired infections (HAI) admitted to the hospital before and after the Beirut explosion. The study was conducted between February 4, 2020 and January 4, 2021. Excluded patients were those transferred from other hospitals and those with community acquired infections. The primary outcome was to identify the rate of growing MDROs post explosion. The secondary outcomes were identifying antibiotics used for surgical prophylaxis in patients requiring surgeries and patients diagnosed with a HAI. Therefore, patients were divided in three groups. Control group included patients admitted with explosion-related injuries on that same day. Patients admitted and between February 4 and August 4 and diagnosed with HAI were compared to those admitted post August 4 with explosion-related HAI and to patients diagnosed with non-explosion-related HAI between August 4 and January 4, 2021. An estimated rate of 18-22% MDRO was needed to achieve a statistical significance with 80% power and 0.05 α. Pearson Chi square test was used to analyze the primary outcome.ResultsA total of 82 patients with 150 cultures were included in this study. Data showed an increase in the rate of MDRO after the explosion with 37.1% of the cultures taken before the explosion and 53.1% after the explosion (p = 0.05). When comparing the types of HAI in both groups, culture sites were significantly different between pre- and post-explosion patients (p = 0.013). However, both groups had similar types of microbes (p = 0.996) with an increase in candida related infections.ConclusionThese findings confirmed that the Beirut explosion impact on antimicrobial resistance was similar to combat zone incidence, where an increase in MDROs rate such as Escherichia coli (E.Coli) and Stenotrophomonas maltophilia, in addition to the increase in candida related infections.

Are Cephalosporins Safe for Surgical Prophylaxis in Patients with Penicillin Allergy?

Cefazolin, also known as Ancef, is a first-generation cephalosporin antibiotic often used in surgery to treat or prevent bacterial infection of the surgical site. Ancef is safe for most of the population; however, many physicians use alternative, less effective medications in patients with penicillin allergy due to a fear of cross-reactivity between Ancef and one's penicillin allergy. In this article, we aim to examine if cefazolin is safe for patients with penicillin allergy.

Antimicrobial use, healthcare-associated infections, and bacterial resistance in general hospitals in China: the first national pilot point prevalence survey report.

The purpose of this study is to implement point prevalence survey (PPS), assess antimicrobial prescribing and resistance in general hospitals and clinical specialties in China, and compare them with similar data from other parts of the world. Twenty general hospitals in China were surveyed in October or November, 2019. A standardized surveillance protocol was used to collect data on patient demographics, diagnosis of infection, the prevalence and intensity of antimicrobial use, prescribing quality, bacterium type and resistance spectrum, and the prevalence and type of healthcare-associated infections (HAIs). Overall, 10,881 beds and 10,209 inpatients were investigated. The overall prevalence of antibiotic use was 37.00%, the use of antibiotic prophylaxis in surgical patients was high (74.97%). The intensity of antimicrobial use was 61.25 DDDs/100 patient days. Only 11.62% of antimicrobial prescriptions recorded the reason for prescribing. Intravenous or combination treatments comprised 92.02% and 38.07%, respectively, and only 30.65% of prescriptions referred to a microbiological or biomarker tests. The incidence of HAIs in all patients was 3.79%. The main associated factors for HAIs included more frequent invasive procedures (27.34%), longer hospital stay (> 1-week stay accounting for 51.47%), and low use of alcohol hand rubs (only 29.79% placed it bedside). Most of the resistant bacteria declined; only carbapenem-resistant Enterobacter is higher than previously reported. The prevalence of antibiotic use in general hospitals fell significantly, the overall bacterial resistance declined, and the incidence of HAI was low. However, the low quality of antimicrobial use requires urgent attention.

Pharmacological interventions for preventing venous thromboembolism in people undergoing bariatric surgery.

Pharmacological interventions for preventing venous thromboembolism in people undergoing bariatric surgery.

Assessment of Antibiotic Prophylaxis in Surgical Patients at a Referral Teaching Hospital in Western Iran

Background: Antibiotic prophylaxis is often used by surgeons to prevent surgical site infection (SSI) following operations. Despite the availability of several national guidelines for proper antibiotic prophylaxis, adherence to guideline recommendations, especially in developing countries, is still sub-optimal. This study aimed to assess adherence to the American Society of Health-System Pharmacists (ASHP) guidelines for prophylactic antibiotic use among surgeons in a referral hospital in western Iran. Methods: This prospective cross-sectional study was conducted in surgery wards of a tertiary hospital affiliated with Hamadan University of Medical Sciences, Hamadan, Iran, for six consecutive months from February 1 to July 31, 2019. The records of 264 patients who were randomly chosen from patients admitted to surgery wards were reviewed. The appropriateness of parameters of surgical antibiotic prophylaxis, including indication, antibiotic choice, dose, timing of the first dose, and duration of prophylaxis, was assessed against ASHP guidelines. Results: A total of 248 patients (93.94%) received antibiotic prophylaxis. Only in 32.2% of the procedures, full adherence to all parameters of the AHSP guidelines was achieved. In a significant percentage of procedures, prophylactic antibiotics were administered inappropriately for more than 24 hours (59.21%). Regarding the antibiotic selection (92.1%), dose (88.6%), and timing of administration (89.9%), the rate of adherence to guidelines recommendations was relatively satisfactory in our hospital. Conclusion: Our survey demonstrated that the adherence of surgeons to antibiotic prophylaxis guidelines was inadequate in our hospital, and there is still considerable room for improvement, especially in the process of discontinuation of antimicrobial prophylaxis.

Principles of Empirical and Therapeutic Antimicrobial Therapy

The goal of this review is to discuss basic principles for the appropriate use of antibiotics in the surgical patient, largely focusing on the treatment of intra-abdominal infections. Limited pharmacologic data on common antibiotics are provided. Current reference sources and institutional guidelines should be used for specifics on dosing and administration. This review covers general principles, including treatment of surgical infections, laboratory tests, pharmacokinetics and pharmacodynamics, adverse reactions, antimicrobial resistance, and antibiotic prophylaxis in surgical patients. In addition, specific considerations of appropriate antimicrobial therapy, such as acute cholecystitis/cholangitis, pancreatitis, appendicitis, diverticulitis, Clostridium difficile, and skin and soft tissue infections are presented. Tables list high-risk factors in intra-abdominal infections, empirical antibiotic based on risk stratification for the treatment of community-acquired intra-abdominal infections, dose adjustments for obese patients, most common isolated pathogens from intra-abdominal infections, 2005–2010, with resistance trends, adaptation of Tokyo guidelines on severity scoring and recommended antimicrobial therapy, and recommended antibiotics for necrotizing soft tissue infections. This review contains 6 tables and 56 references

Principles of Empirical and Therapeutic Antimicrobial Therapy

The goal of this review is to discuss basic principles for the appropriate use of antibiotics in the surgical patient, largely focusing on the treatment of intra-abdominal infections. Limited pharmacologic data on common antibiotics are provided. Current reference sources and institutional guidelines should be used for specifics on dosing and administration. This review covers general principles, including treatment of surgical infections, laboratory tests, pharmacokinetics and pharmacodynamics, adverse reactions, antimicrobial resistance, and antibiotic prophylaxis in surgical patients. In addition, specific considerations of appropriate antimicrobial therapy, such as acute cholecystitis/cholangitis, pancreatitis, appendicitis, diverticulitis, Clostridium difficile, and skin and soft tissue infections are presented. Tables list high-risk factors in intra-abdominal infections, empirical antibiotic based on risk stratification for the treatment of community-acquired intra-abdominal infections, dose adjustments for obese patients, most common isolated pathogens from intra-abdominal infections, 2005–2010, with resistance trends, adaptation of Tokyo guidelines on severity scoring and recommended antimicrobial therapy, and recommended antibiotics for necrotizing soft tissue infections. This review contains 6 tables and 56 references

Principles of Empirical and Therapeutic Antimicrobial Therapy

The goal of this review is to discuss basic principles for the appropriate use of antibiotics in the surgical patient, largely focusing on the treatment of intra-abdominal infections. Limited pharmacologic data on common antibiotics are provided. Current reference sources and institutional guidelines should be used for specifics on dosing and administration. This review covers general principles, including treatment of surgical infections, laboratory tests, pharmacokinetics and pharmacodynamics, adverse reactions, antimicrobial resistance, and antibiotic prophylaxis in surgical patients. In addition, specific considerations of appropriate antimicrobial therapy, such as acute cholecystitis/cholangitis, pancreatitis, appendicitis, diverticulitis, Clostridium difficile, and skin and soft tissue infections are presented. Tables list high-risk factors in intra-abdominal infections, empirical antibiotic based on risk stratification for the treatment of community-acquired intra-abdominal infections, dose adjustments for obese patients, most common isolated pathogens from intra-abdominal infections, 2005–2010, with resistance trends, adaptation of Tokyo guidelines on severity scoring and recommended antimicrobial therapy, and recommended antibiotics for necrotizing soft tissue infections. This review contains 6 tables and 56 references

Safety and Effectiveness of High-Dose Cefazolin in Patients With High Body Weight: A Retrospective Cohort Study.

BackgroundCefazolin is a commonly used antibiotic for the treatment of mild to severe infections. Despite the use of higher dose of cefazolin (3 g/dose) for surgical prophylaxis in patients with obesity, there is currently a paucity of data identifying the optimal dose to treat infections in this specific patient population.MethodsThis was a multicenter, retrospective cohort study of patients who received cefazolin at weight-based (up to 9 g/day) or standard doses (up to 6 g/day) for the treatment of bacteremia or skin and soft tissue infection (SSTI). Study groups were stratified by body weight and cefazolin dose received. Primary outcome was the composite of treatment-emergent adverse events (TEAEs) and secondary outcome was treatment failure rate.ResultsA total of 208 patients were included for study analysis. Fifty-nine patients had body weight >120 kg. Of these, 33 received high-dose cefazolin while 26 received standard doses. The remaining 149 patients had body weight of ≤120 kg and received standard doses. The occurrence of TEAEs did not differ across the 3 groups. The study also did not find any difference between the rate of treatment failure between groups.ConclusionsHigh-dose cefazolin (9 g/day) for the treatment of bacteremia or SSTIs in patients with high body weight was safe and well tolerated. Larger studies are needed to further explore the benefit of high-dose cefazolin in improving clinical outcomes.

Comparison of strategies for adherence to venous thromboembolism prophylaxis in high-risk surgical patients: a before and after intervention study

BackgroundVenous thromboembolism (VTE) is a major cause of perioperative morbimortality. Despite significant efforts to advance evidence-based practice, prevention rates remain inadequate in many centres.ObjectiveTo evaluate the effectiveness of different strategies...

Implementation of the Choosing Wisely Program in the General Surgery Residency

The practice of unnecessary conduct and waste in Health is an important topic, not often addressed during undergraduate training. Medical education has a fundamental role in student and doctors' training concerning cost-conscious attitudes for good health care. The aim of this study was to describe and assess the implementation of the Choosing Wisely campaign within a General Surgery residency program. This was an interventional study involving residency advisors and specialty residents. Recommendations based on three procedures frequently used in clinical practice, with no benefits and involving unnecessary risks for patients were identified by residency advisors with the use of the Delphi method and were grouped by frequency and by nature according to the Choosing Wisely layout. Educational actions such as workshops and banner advertising in addition to training activities regarding cost-conscious healthcare were carried out. This subject was also included in the theoretical evaluation of the residency program. The leading five recommendations were related to (i) computed tomography overuse (versus ultrasound imaging) in patients with suspected acute appendicitis, (ii) multithreaded computed tomography overuse in patients with low-risk trauma, (iii) longer than recommended antibiotic prophylaxis in surgical patients, (iv) longer than recommended preoperative fasting period and (v) upper gastrointestinal endoscopy overuse in surgical patients without an adequate clinical evidence or without the presence of warning signs. Awareness and reflection among participants were improved, leading to high grades in final evaluation. Changes in training regarding quality of care and cost awareness should start throughout undergraduate training, within a learning environment focused on a reflective and evidence-based practice. All the benefits and harms to patients were taken into account in the recommendations that emerged from this study. The inclusion of this initiative in the General Surgery residency, involving reflective discussions on campaign recommendations regarding procedures frequently used in clinical practice, with no benefits and involving unnecessary risks for patients may lead to more cost-conscious procedures.

Assessment of Antibiotic Prophylaxis in Surgical Patients and Association Factors at Thu Duc District Hospital, Ho Chi Minh City, Vietnam in 2018.

Surgical antibiotic prophylaxis (SAP) is considered an important interventional tool for antimicrobial resistance. Guideline compliance was poor across different countries and this results in an inappropriate and overuse of antibiotics. The study was cross-sectional, combining qualitative and quantitative. The Research used the MOH’s Antibiotic Preventive Medicine Guidelines as the standard to verify surgical preventive treatment compliance from patient medical records. Research performed on 373 medical records with surgical indications. The study was conducted from January to June 2019. Data were entered using Epidata software and processed by SPSS software version 19.0. Analysis: calculating OR for related factors. The compliance rate of using prophylactic antibiotics was 83.1%. There is a relationship between the type of incision, the length of time surgery, and compliance with surgical prophylactic use of antibiotics (P < .05). Barriers to adherence to prophylactic antimicrobial therapy include: overcrowding patients, health-care workers “broad-spectrum antibiotic use habits, and health-care workers” views on surgical and muscle environment, the material was not completely sterilized.

98. Antibiotic Stewardship Interventions Significantly Improve Preferred Antibiotic Prophylaxis in Total Joint Arthroplasty

BackgroundMost patients reporting a penicillin (PCN) allergy can tolerate cefazolin, the preferred prophylaxis in a total joint arthroplasty (TJA). The purpose of this study was to evaluate surgical prophylaxis in patients with a reported PCN allergy undergoing a TJA following a stewardship intervention that included updates to institutional guidelines, reclassification of severe PCN allergy, standardization of ordering processes, and participation of a physician champion.MethodsThis was a single center, retrospective study of adult orthopedic patients greater than 18 years old who underwent a primary elective TJA at a 261-bed community hospital from March 1, 2017 to August 30, 2017 (pre-intervention) and from March 1, 2019 to August 30, 2019 (post-intervention). The primary outcome was the difference in the composite rate of the following: 1) Patients with a reported non-severe PCN allergy without MRSA risk factors who received cefazolin; 2) Patients with a non-severe PCN allergy with MRSA risks factors who received cefazolin plus vancomycin; and 3) Patients with a severe PCN allergy who received vancomycin prior to a primary elective TJA.ResultsA total of 180 patients with a documented PCN allergy were evaluated (90 patients in the pre-intervention group and 90 patients in the post-intervention group). Rash and hives were the most commonly reported allergies in both groups (71% vs 61%, P=0.2076). Post-intervention revealed a significant increase in the primary outcome of appropriate perioperative antibiotic (55% vs 91%, P< 0.001), largely driven by patients with non-severe allergy [47% (36/76) vs 96% (73/76), P< 0.001]. No patients had signs of an allergic reaction thought to be due to cefazolin, including 8 patients with severe PCN allergy. No patients in either group developed a surgical site infection or C. difficile infection within 90 days post-procedure.ConclusionA multifaceted antibiotic stewardship intervention increased preferred prophylaxis in elective primary TJA. Patients with non-severe PCN allergies, even those reporting hives or local swelling, can tolerate cefazolin without issue. Patients with severe PCN allergy should undergo further evaluation as cefazolin may be a safe option.DisclosuresKatelyn Quartuccio, PharmD, BCPS, AstraZeneca (Consultant) Kelly E. Pillinger, PharmD, BCIDP, Pharmacy Times (Other Financial or Material Support, Speaker)

Efficacy and safety of fibrinogen concentrate for on-demand treatment of bleeding and surgical prophylaxis in paediatric patients with congenital fibrinogen deficiency.

BackgroundCongenital fibrinogen deficiency (CFD) is a rare, inherited disorder affecting normal blood clotting function, where patients can experience severe and/or frequent bleeding episodes (BEs). Treatment with human fibrinogen concentrate (HFC) can prevent/arrest bleeding. There is a need for more data on the efficacy, pharmacokinetics (PK) and safety of HFC treatment in paediatric patients with CFD.MethodsHaemostatic efficacy of HFC (Fibryga®, Octapharma AG) for on‐demand treatment of bleeding and surgical prophylaxis in patients <12 years old was assessed by investigators and an Independent Data Monitoring and Endpoint Adjudication Committee (IDMEAC) based on an objective 4‐point efficacy scale. Maximum clot firmness (MCF; surrogate marker of haemostatic efficacy), single‐dose PK and safety were also assessed.ResultsOf 14 patients receiving HFC (median [range] age 6.0 years [1.0–10.0]), eight received HFC for 10 BEs, three for surgical prophylaxis and 13 for PK. The IDMEAC rated haemostatic efficacy as 100% successful for on‐demand BE treatment (95% CI 69.15–100.00) and surgical prophylaxis (95% CI 29.24–100.00). After a mean first dose of 70.78 mg/kg for BEs, mean (±SD) MCF significantly increased from pre‐treatment to 1‐hour post‐infusion (3.3 mm [±1.77]; P = 0.0002), coinciding with haemostatic efficacy. PK parameters were favourable. Two possibly related adverse events occurred, including one serious (portal vein thrombosis). No allergic/hypersensitivity reactions or deaths were observed.ConclusionHFC treatment for on‐demand treatment of BEs and surgical prophylaxis was efficacious for this ultra‐rare paediatric population with congenital afibrinogenaemia and showed a favourable PK and safety profile.

Octanate®: over 20 years of clinical experience in overcoming challenges in haemophilia A treatment.

Treatment of haemophilia A with FVIII replacement has evolved over the past decades to adapt to the needs of patients. octanate®, a plasma-derived, double virus-inactivated, von Willebrand factor (VWF)-containing FVIII concentrate, has been used in clinics worldwide for over 20 years. First licensed in 1998 in Germany, octanate® is approved in over 80 countries for the prevention and treatment of bleeding and for surgical prophylaxis in patients with haemophilia A, and in over 40 countries for immune tolerance induction (ITI). The manufacturing process for octanate® was developed to ensure high viral safety and effectively eliminates both enveloped and nonenveloped viruses. Over the past 20 years, the excellent safety and efficacy of octanate® have been demonstrated in pivotal clinical trials in adult and paediatric previously treated patients (PTPs) for on-demand treatment, prophylaxis and as surgical cover. Importantly, octanate® has displayed low immunogenicity in previously untreated patients (PUPs), with only 9.8% of PUPs developing FVIII inhibitors. octanate® has also shown to be highly effective in inhibitor elimination when used as ITI therapy. In a population of patients with high risk of ITI failure, success was achieved in 79.2% of patients (70.8% complete success), even when using exceptionally stringent success criteria. No relapses were observed. Here we present an overview of the clinical data with octanate® that support its use in a range of patient populations and clinical indications.

1094. Safety of Administering Cefazolin vs. Other Antibiotics in Penicillin Allergic Patients with Anaphylaxis for Surgical Prophylaxis

BackgroundApproximately 10% of patients report a history of penicillin allergy. Recent literature suggests cross-reactivity between cephalosporins and penicillins are due to side-chain similarities. Since cefazolin has a unique side-chain from other β lactams, it can be safely administered in penicillin-allergic patients for surgical prophylaxis. Since October 2018, our hospital updated all surgical prophylaxis preprinted orders to use cefazolin in penicillin-allergic patients, except in those with histories of cefazolin-specific allergy or delayed skin reactions (e.g., Stevens–Johnson syndrome). This study aims to retrospectively determine outcomes and safety of cefazolin as compared with other antibiotics for surgical prophylaxis in penicillin-allergic patients with histories of anaphylaxis prior to implementation of cefazolin preprinted orders.MethodsAll patients with reported anaphylactic reactions to penicillins prescribed surgical prophylaxis from October 9, 2017 to October 9, 2018 were included. Patients were stratified based on antibiotic received (i.e., cefazolin, clindamycin, vancomycin, other antibiotic) and a retrospective chart review was performed to assess for outcomes and safety.ResultsOne-thousand-seventy-three prescriptions for prophylactic antibiotics were identified. Of these, 223 cases met inclusion with histories of anaphylaxis to pencillins: 72 (32%) cefazolin, 70 (31%) clindamycin, 34 (15%) vancomycin, and 47 (21%) other antibiotics. General and orthotrauma surgeries used the most cefazolin in penicillin-allergic patients, while gynecology clindamycin and thoracics vancomycin. Amongst those receiving cefazolin, no critical incidents of allergic reactions were reported and the rates of adverse events, such as pruritus, hives and rash, did not differ between any antibiotic group.ConclusionCefazolin appears to be a safe option for surgical prophylaxis in patients with history of penicillin anaphylaxis. No differences in incidences of allergic reactions, complications or surgical delays were reported, as compared with alternate antibiotics. Further larger studies are needed to confirm our findings and determine rates of adverse events associated with the various antibiotic regimens.Disclosures All authors: No reported disclosures.

A study on the antimicrobial usage pattern for the prevention of surgical site infections in a teaching hospital

Background: Wrong antimicrobial selection and usage increase the incidence of drug resistance, drug toxicity and superinfections, thus decreasing the quality of healthcare delivery. Various approaches for rationalizing the antimicrobial usage have been recommended. Understanding the existing antimicrobial usage pattern is suggested as the first step in this approach, which would help to understand the current issues and to find the solution. The aim of the study was to evaluate the usage pattern of antimicrobial prophylaxis in surgical patients, to identify any inappropriateness of the usage.Methods: A retrospective evaluation of the randomly selected 258 medical records of general surgical cases for eight months in a tertiary care teaching hospital were verified for the appropriateness of the antimicrobial prophylaxis. The collected data was studied, and conclusions were drawn with the help of appropriate statistics.Results: All the 262 (100%) patients received a third generation cephalosporin through the intravenous route as a prophylactic dose. Also, 92 (35%) patients received nitroimidazole or aminoglycosides in addition to the cephalosporins. The antimicrobials were administered half an hour to one hour before the surgery. No intraoperative redosing was given.Conclusions: The timing of administration of the preoperative dose was at par with international guidelines and well allotted to the nursing staff. The intraoperative dose was appropriately omitted in the short term surgeries. The main concern was the increasing use of the third generation cephalosporins and the long duration of the postoperative prophylaxis, which required to be addressed.

Efficacy and Safety of Fibrinogen Concentrate for on-Demand Treatment of Acute Bleeding and for Surgical Prophylaxis in Subjects with Congenital Fibrinogen Deficiency — a Phase 3 Study

Introduction: Congenital afibrinogenemia is a rare inherited disorder characterized by an absence of plasma fibrinogen. Affected individuals have a highly variable bleeding tendency, which can be severe and include life-threatening bleeding and spontaneous/trauma-related bleeds. Therapeutic substitution with human fibrinogen concentrate (HFC) can correct the hemostatic defect and arrest bleeding. The FORMA-02 study investigated the hemostatic efficacy of a new plasma-derived, double virus-inactivated HFC (Fibryga, Octapharma) for on-demand treatment of bleeding episodes (BEs) and for surgical prophylaxis in patients with afibrinogenemia.Methods: FORMA-02 was a prospective, open-label, uncontrolled, multicenter Phase 3 study. A total of 25 patients with congenital afibrinogenemia (≥12 years) received the new HFC for treatment of a BE and/or for surgical prophylaxis. HFC was individually dosed to achieve a recommended target fibrinogen plasma level dependent on the bleeding type or surgery type (minor or major). The primary endpoint was the efficacy of the new HFC for on-demand treatment of the first BE after signed consent was obtained. Secondary endpoints included hemostatic efficacy of the HFC for the treatment of all BEs during the study period and its efficacy in preventing bleeding during and after surgery. Hemostatic efficacy was assessed by investigators and an Independent Data Monitoring and Endpoint Adjudication Committee (IDMEAC) using objective four-point scales, with treatment success defined as a rating of excellent or good. Thromboelastometry maximum clot firmness (MCF) was also investigated as a surrogate marker of efficacy.Results: A total of 25 patients received the new HFC for treatment of a BE (N=24) and/or surgical prophylaxis (N=9). The mean±SD dose of HFC was 65.51±26.47 mg/kg per BE (89 events) and 40.45±30.78 mg/kg per surgery for surgical prophylaxis (12 events). Hemostatic efficacy for treatment of the first BE (primary endpoint) was rated as excellent or good for all patients by both the investigator and the IDMEAC (Success: 100%; 90% CI 0.89-1.00). When all BEs were evaluated (N=89 BEs in 24 patients), hemostatic efficacy was rated as excellent or good for 96.6% of events by the investigator and 98.9% by the IDMEAC. The first HFC infusion for treatment of the first BE for each patient led to a mean increase in blood fibrinogen concentration of 114.74±25.28 mg/dL 1 hour after administration, while the MCF increased by a mean of 6.48±3.07 mm.Intraoperative hemostatic efficacy for surgical prophylaxis was rated by the surgeon and the IDMEAC as excellent or good for 100% of the 12 surgeries that were performed (success: 100%; 90%CI 0.82-1.00). Postoperative efficacy was also rated as excellent or good in all cases. The first HFC infusion for each surgery led to a mean increase in blood fibrinogen concentration of 104.55±43.64 mg/dL at 1 hour after administration.A total of 15 serious adverse events (SAEs) occurred in 5 patients; only one was deemed to be related to the HFC by the investigator. This was a digital ischemia that resolved without sequelae. No inhibitory anti-fibrinogen antibodies were detected and there were no severe allergic or hypersensitivity reactions related to the HFC.Conclusions: These data indicate that the new HFC was efficacious for on-demand treatment of acute bleeding and for surgical prophylaxis in patients with congenital afibrinogenemia, with hemostatic efficacy rated as 100% in both settings. The HFC showed an acceptable safety profile in this study population. DisclosuresPeyvandi:Grifols: Speakers Bureau; Octapharma US: Honoraria; Roche: Speakers Bureau; Shire: Speakers Bureau; Octapharma US: Honoraria; Roche: Speakers Bureau; Shire: Speakers Bureau; Sobi: Speakers Bureau; Shire: Speakers Bureau; Novo Nordisk: Speakers Bureau; Sobi: Speakers Bureau; Novo Nordisk: Speakers Bureau; Octapharma US: Honoraria; Shire: Speakers Bureau; Novo Nordisk: Speakers Bureau; Octapharma US: Honoraria; Octapharma US: Honoraria; Novo Nordisk: Speakers Bureau; Ablynx: Other: Member of Advisory Board, Speakers Bureau; Ablynx: Other: Member of Advisory Board, Speakers Bureau; Ablynx: Other: Member of Advisory Board, Speakers Bureau; Ablynx: Other: Member of Advisory Board, Speakers Bureau; Ablynx: Other: Member of Advisory Board, Speakers Bureau; Kedrion: Consultancy; Kedrion: Consultancy; Kedrion: Consultancy; Kedrion: Consultancy; Kedrion: Consultancy; Grifols: Speakers Bureau; Grifols: Speakers Bureau; Grifols: Speakers Bureau; Novo Nordisk: Speakers Bureau; Grifols: Speakers Bureau; Roche: Speakers Bureau; Roche: Speakers Bureau; Roche: Speakers Bureau; Shire: Speakers Bureau; Sobi: Speakers Bureau; Sobi: Speakers Bureau; Sobi: Speakers Bureau. Schwartz:Octapharma US: Employment. Knaub:Octapharma AG: Employment.