Systemic Prophylaxis Research Articles

One-shot versus multidose perioperative antibiotic prophylaxis after kidney transplantation: A randomized, controlled clinical trial

There is no consensus on the optimal perioperative antibiotic prophylaxis regimen for renal transplant recipients. Some studies have reported that irrigation of the wound at the time of closure without systemic antibiotics may suffice to minimize the risk for surgical site infection (SSI), but many centers still use long-term, multidose regimens in which antibiotics are administered until removal of foreign bodies occur, such as the urethral catheter, drain and central line. We designed a prospective, randomized, multicenter, controlled trial to compare a single dose versus a multidose regimen of systemic antibiotic prophylaxis in adult, nondiabetic, non-morbidly obese patients undergoing renal transplantation. The primary endpoint was the incidence of SSI; the assessment of other infection in the first postoperative month was the secondary endpoint. Two hundred five patients were enrolled and randomized to receive either a single (n = 103) or multidose antibiotic regimen (n = 102) for prophylaxis. The incidences of SSI and urinary tract infection were similar in both groups. As the dramatic increase in antibiotic resistance has mandated the implementation of global programs to optimize the use of antibiotic agents in humans, we believe that the single dose regimen is preferred, at least in nondiabetic, non-morbidly obese, adult renal transplant recipients.

Matrix Vaginal Ring Formulations that Maintain Target In Vitro Release Rates of Dapivirine and Levonorgestrel (Alone or in Combination) over 90 Days

AIDS Research and Human RetrovirusesVol. 30, No. S1 MPT DevelopmentMatrix Vaginal Ring Formulations that Maintain Target In Vitro Release Rates of Dapivirine and Levonorgestrel (Alone or in Combination) over 90 DaysJonathon Holt, Andrew Brimer, Susan Fetherston, Peter Boyd, Brid Devlin, and Karl MalcolmJonathon HoltIPM, Silver Spring, MD, United StatesSearch for more papers by this author, Andrew BrimerIPM, Silver Spring, MD, United StatesSearch for more papers by this author, Susan FetherstonUniversity of Ulster, Coleraine, United KingdomSearch for more papers by this author, Peter BoydQueen's University Belfast, Belfast, United KingdomSearch for more papers by this author, Brid DevlinIPM, Silver Spring, MD, United StatesSearch for more papers by this author, and Karl MalcolmQueen's University Belfast, Belfast, United KingdomSearch for more papers by this authorPublished Online:30 Oct 2014https://doi.org/10.1089/aid.2014.5276.abstractAboutSectionsView articleView Full TextPDF/EPUB ToolsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail View article"Matrix Vaginal Ring Formulations that Maintain Target In Vitro Release Rates of Dapivirine and Levonorgestrel (Alone or in Combination) over 90 Days." AIDS Research and Human Retroviruses, 30(S1), pp. A138–A139FiguresReferencesRelatedDetailsCited ByLong acting systemic HIV pre-exposure prophylaxis: an examination of the field13 June 2017 | Drug Delivery and Translational Research, Vol. 7, No. 6Will dapivirine redeem the promises of anti-HIV microbicides? Overview of product design and clinical testingAdvanced Drug Delivery Reviews, Vol. 103An update on multipurpose prevention technologies for the prevention of HIV transmission and pregnancy22 January 2016 | Expert Opinion on Drug Delivery, Vol. 13, No. 4Recent work on vaginal rings containing antiviral agents for HIV preventionCurrent Opinion in HIV and AIDS, Vol. 10, No. 4 Volume 30Issue S1Oct 2014 InformationCopyright 2014, Mary Ann Liebert, Inc.To cite this article:Jonathon Holt, Andrew Brimer, Susan Fetherston, Peter Boyd, Brid Devlin, and Karl Malcolm.Matrix Vaginal Ring Formulations that Maintain Target In Vitro Release Rates of Dapivirine and Levonorgestrel (Alone or in Combination) over 90 Days.AIDS Research and Human Retroviruses.Oct 2014.A138-A139.http://doi.org/10.1089/aid.2014.5276.abstractPublished in Volume: 30 Issue S1: October 30, 2014PDF download

PO-0559 Candida Bloodstream Infections In A Nicu (2001–2012)

<h3>Background and aims</h3> Recent reports indicate that the incidence of Candida ssp. bloodstream infection (BSI) is decreasing among NICU patients, and is associated with antifungal prophylaxis and the dwell time of peripherally inserted central catheters (PICCs). This study describes the epidemiology of invasive fungal infections in a single NICU. <h3>Methods</h3> We conducted a retrospective study of invasive candidiasis occurring in 6730 infants admitted to our NICU. Positive fungal blood cultures were identified through searching our microbiology database. <h3>Results</h3> From a total of 2637 blood cultures performed during the study period, there were 6 (&lt;0.1%) Candida spp. (Candida albicans n = 5, Candida lusitaniae n = 1) BSIs reported. In 3 cases premature rupture of membranes was observed, and in 2 cases maternal vaginal smears were positive for Candida ssp. All Patients with Candida albicans BSI (Gestational age 24.3 to 27.0 weeks) had PICCs, while blood cultures became positive between day 1 to 10. 1 patient died on day 13. Treatment consisted in Fluconazole (67%), Amphotericin B (33%), and Caspofungin (17%), partially combined. Persistent positive Candida BSIs were not reported. Systemic antifungal prophylaxis is not implemented at our NICU. During the same period 402 positive fungal cultures in 198 patients were documented from other sources. <h3>Conclusions</h3> Even without prophylactic systemic antifungal therapy at our NICU the observed rate of Candida BSIs is low but in line with other studies. Prenatal vaginal smears might help to detect ELBW infants being at high risk for candidemia.

Preoperative Systemic Antimicrobial Prophylaxis in Contaminated Middle Ear Surgery for Cholesteatoma

Objectives: Evaluate the efficacy of combined anti-staphylococcal and anti-pseudomonal preoperative antibiotics for preventing surgical site infections following tympanoplasty and mastoidectomy (TM) with contaminated cholesteatoma. Methods: Study Design: Retrospective chart review Method: Medical records of patients who underwent TM for cholesteatoma were reviewed. Only cases considered to have contaminated or dirty/infected surgical fields were included. Patients were excluded if there was preexisting infection or intraoperative finding requiring systemic antibiotic therapy. The primary outcome measure was postoperative perichondritis, pinna abscess, peri-otic cellulitis, and peri-otic abscess requiring systemic antibiotics or surgical intervention. Results: The charts of 362 patients who underwent TM were reviewed. 195 met inclusion criteria. Preoperative antibiotics included clindamycin and ceftazidime or gentamicin. Patients treated with no perioperative antibiotics had an infection rate of 11% and those treated with perioperative antibiotics had a rate of 1% ( P = .02). Conclusions: The use of preoperative antibiotics to cover staphylococcal and pseudomonal species prevented surgical site infections as compared to no perioperative antibiotics.

Important issues for perioperative systemic antimicrobial prophylaxis in surgery.

Prevention of surgical site infections is a key issue to patient safety and the success of surgical interventions. Systemic antimicrobial prophylaxis is one important component of a perioperative infection prevention bundle. This review focuses on selected recent developments and important concepts in the field. Joint guidelines (American Society of Health-System Pharmacists, Infectious Diseases Society of America, Surgical Infection Society, Society for Healthcare Epidemiology of America) for antimicrobial prophylaxis in surgery have been recently revised and updated. Furthermore, European Centre for Disease Prevention and Control has issued a report identifying key factors for success. Important updated fields include the duration of prophylaxis; the selection and dosing of the antimicrobial drug; the precise timing of administration; and common and basic principles, including the implementation of local guidelines and attributing the responsibility of appropriate timing to anaesthesiologists. Additionally, the role of preoperative selective digestive decontamination (SDD) in gastrointestinal surgery receives increasing attention. A major concern of SDD, namely increasing microbial resistance, has not been demonstrated to date. Most frequently, anaesthesiologists administer perioperative antimicrobial prophylaxis. Identification of core principles and harmonization of protocols should facilitate this task and thus help to improve patient safety and to monitor compliance. However, local and regional epidemiology have to be taken into account in order to establish local protocols.

Surgical wound infections after peripheral vascular surgery.

Surgical wound infection is one of the most common complications after peripheral vascular surgery. It increases the affected patient's risk for major amputation as well as mortality. Furthermore, surgical wound infection is an additional cost. Wound infections after vascular surgery are of multifactorial nature and generally result from the interplay of patient- and procedure-related factors. The use of systemic antibiotic prophylaxis may be the most important method in preventing surgical wound infections. In this review article, we report the current literature of surgical wound infections after peripheral vascular surgery.

Impact of Rifaximin on the Frequency and Characteristics of Spontaneous Bacterial Peritonitis in Patients with Liver Cirrhosis and Ascites

BackgroundRifaximin is a non-absorbable antibiotic used to prevent relapses of hepatic encephalopathy which may also be a candidate for prophylaxis of spontaneous bacterial peritonitis (SBP).AimTo detect the impact of rifaximin on the occurrence and characteristics of SBP.MethodsWe prospectively studied all hospitalized patients that underwent a diagnostic paracentesis in our department from March 2012 to April 2013 for SBP and recorded all clinical data including type of SBP prophylaxis, prior use of rifaximin, concomitant complications of cirrhosis, as well as laboratory results and bacteriological findings. Patients were divided into the following three groups: no antibiotic prophylaxis, prophylaxis with rifaximin or with systemically absorbed antibiotic prophylaxis.ResultsOur study cohort comprised 152 patients with advanced liver cirrhosis, 32 of whom developed SBP during the study period. As expected, our study groups differed regarding a history of hepatic encephalopathy and SBP before inclusion into the study. None of the 17 patients on systemic antibiotic prophylaxis developed SBP while 8/27 patients on rifaximin and 24/108 without prophylaxis had SBP (p = 0.02 and p = 0.04 versus systemic antibiotics, respectively). In general, episodes of SBP were similar for patients treated with rifaximin and those without any prophylaxis. However, Escherichia coli and enterococci were dominant in the ascites of patients without any prophylaxis, while mostly klebsiella species were recovered from the ascites samples in the rifaximin group.ConclusionRifaximin pretreatment did not lead to a reduction of SBP occurrence in hospitalized patients with advanced liver disease. However, the bacterial species causing SBP were changed by rifaximin.

Control strategies to prevent total hip replacement-related infections: a systematic review and mixed treatment comparison

ObjectiveTo synthesise the available evidence and estimate the comparative efficacy of control strategies to prevent total hip replacement (THR)-related surgical site infections (SSIs) using a mixed treatment comparison.DesignSystematic review and...

Interaction between Levothyroxine and Phenprocoumon: a case report

Abstract Several case reports have associated the combined use of thyroid drugs and oral anticoagulants, like coumarin, with overanticoagulation. However, this effect has never been described for phenprocoumon, a coumarin derivate that is widely prescribed in continental European countries and in Latin America. We describe a 62-year-old female who had an unexpectedly labile anticoagulation profile when levothyroxine (Puran T4®) was added to her drug therapy regimen, which included phenprocoumon (Marcoumar®). This resulted in an elevated international normalized ratio (INR) that was unrecordable and bleeding (macroscopic hematuria) that required hospitalization and treatment with vitamin K. The patient had been taking phenprocoumon for almost ten years for systemic embolism prophylaxis because of her history of mechanical bileaflet mitral valve prosthesis. One month before the events described, the patient was prescribed sodium levothyroxine (50 mcg daily) to treat hypothyroidism (TSH = 40 µU/mL; reference range, 0.40–4.0 µU/mL). Approximately 3 weeks prior to initiation of levothyroxine treatment, her INR was 2.8. A drug interaction was therefore suspected. The Horn Drug Interaction Probability Scale (DIPS) indicated a probable interaction between oral phenprocoumon and levothyroxine in this case. Clinicians should be aware that levothyroxine may interact with oral phenprocoumon, resulting in overanticoagulation.

Local irrigation of the surgical field with antibiotics in the end of procedure reduces the infection rate in herniated lumbar disc surgery.

Introduction:Reported rate of infections after lumbar discectomy is 1%–15 %. This complication may result in disability or even the death.AimThe aim of the study is to assess the rate of infection associated with lumbar discectomies when combined systemic and local antibiotic prophylaxis was employed.Patients and methods:In this retrospective study we analyzed all patients operated for herniated lumbar disc from 2009 -2012 in our institute. Beside of receiving systemic prophylaxis with 2g of Cefazoline, all patients had their operative field irrigated at the end of operation with Amikacin sulfate injection. Wound was considered infected when local and systemic signs of infection were revealed and were associated with elevated ESR, leukocytosis and elevated CRP. Assessment of infection is done by neurosurgeon during the hospitalization and later at outpatient’s clinic along postoperative course of three months.Results:A total of 604 patients were operated, of those 285 patients (47.2 %) females and 319 males (52.8 %), 12 patients were operated on two levels (1.98 %). Average patient age was 32.5 years (range 20–65 years) Localization of herniated disc was: in L/2-L/3 20 patients or 3.3 %, the L/3-L/4 level 42 patients or 7 % , the L/4 -L /5 262 patients or 43.3 % at the level L/V- S/1 280 patients or 46.3 %. Three patients (0.49%) developed wound infection, two of them superficial infection only with local signs: local pain, redness and leakage. They were treated with oral antibiotics. One with deep wound infection. He presented with local and systemic signs and treated with i.v antibiotics. All the cultures from wound swab revealed staphylococcus aureus.Conclusion:Prophylaxis with systemic antibiotic (Cefazoline 2.0) intravenous administration 30 minutes before the incision and irrigation of operative field with local antibiotic Amikacine sulfate at the end of procedure reduces the infection rate in patients operated for herniated lumbar disc when compared with systemic antibiotic prophylaxis only.

Effects of Using Intravenous Antibiotic Only Versus Local Intrawound Vancomycin Antibiotic Powder Application in Addition to Intravenous Antibiotics on Postoperative Infection in Spine Surgery in 907 Patients

A prospective randomized controlled trial. To assess the ability of local vancomycin powder in controlling postoperative infection in spine surgery. Despite improvements through the use of prophylactic systemic antibiotics, surgical site infections remain a significant problem in spine surgical procedures. Various retrospective and prospective studies have reported the efficacy of local application of vancomycin powder in reducing the infection in animal and human studies. However, there were no randomized control trials that reported on its efficacy. Prospective randomized controls of 907 patients with various spinal pathologies were treated surgically during a period of 18 months. The control group received standard systemic prophylaxis only, whereas the treatment group received vancomycin powder in the surgical wound in addition to systemic prophylaxis. Patient demographics, comorbidities, level of spinal pathology, estimated blood loss, nutritional status, and hemoglobin were recorded. Incidence of infection was the primary outcome evaluated. There were 8 infections (1.68%) in the control group (6 instrumented and 2 noninstrumented, 6 deep and 2 superficial) with bacteria cultured in 3 (1 Escherichia coli and 2 Staphylococcus aureus). In the treatment group, 7 infections (1.61%) were observed (6 instrumented and 1 noninstrumented surgical procedures, 6 deep and 1 superficial) with bacteria cultured in 3 (1 Staphylococcus aureus and 2 Klebsiella). No adverse effects were observed from the use of vancomycin powder. Statistically no significant difference was seen in infection rate between the treatment group and control group. The local application of vancomycin powder in surgical wounds did not significantly reduce the incidence of infection in patients with surgically treated spinal pathologies. The use of vancomycin powder may not be effective when incidence of infection is low.

Impact Of Systemic Antibiotic Prophylaxis In Hematopoietic Stem Cell Transplantation Recipients. A Meta-Analysis Of Randomized Controlled Trials

Objectives Fever during neutropenia occurs in &gt; 90% and 80% of allogeneic and autologous hematopoietic stem cell transplantation (HSCT) recipients, respectively. Current guidelines recommend the prophylaxis with fluoroquinolones (FQs) in HSCT patients. Although there is evidence that antibiotic prophylaxis improve clinical outcome in patients with chemotherapy-induced neutropenia, prophylactic antibiotic therapy has not been thoroughly evaluated in HSCT recipients. Therefore, we performed a meta-analysis to evaluate the impact of systemic antibiotic prophylaxis in HSCT recipients on mortality, incidence of infection and related adverse events. Data sources We identified reports that were not restricted to those in English and not restricted to published trials through PubMed, the Cochrane Library, and references of identified studies. Review Methods We included prospective, randomized studies on systemic antibiotic prophylaxis in HSCT recipients. The outcome measures included the all-cause mortality, infection-related mortality, febrile episodes, incidence of clinically or microbiologically documented infection, bacteremia, or related adverse events. The summarized odds ratios (ORs) were calculated using the Mantel–Haenszel method and the DerSimonian–Laird method. Results Seventeen trials with 1453 patients (842 autologous and 407 allogeneic HSCT recipients) were included. The percentage of autologous and allogeneic HSCT recipients was not specified in 2 trials. Systemic antibiotic prophylaxis was compared with placebo or no prophylaxis in 10 trials and with non-absorbable antibiotic in 2 trials, respectively. Systemic antibiotics other than FQs were evaluated in five out of these 12 trials. Four trials evaluated the effect of addition of antibiotics for gram positive bacteria to FQs. Remaining 1 trial compared the two different systemic antibiotic regimens, FQs versus trimethoprim sulfamethoxazole. As a result, systemic antibiotic prophylaxis reduced the incidence of febrile episodes (OR 0.16; 95 percent confidence interval [CI], 0.09-0.30), clinically or microbiologically documented infection (OR 0.41; 95% CI 0.30-0.57) and bacteremia (OR 0.37; 95% CI 0.26-0.53) without the significant effect on all-cause mortality or infection-related mortality (OR 0.89; 95% CI 0.48-1.66, OR 1.37; 95% CI 0.50-3.76, respectively). Impact of prophylaxis with FQs on mortality was inconclusive because of small number of clinical trials evaluated. Adverse events increased in patients with systemic antibiotic prophylaxis compared to controls (OR 3.32; 95% CI 1.45-7.63). In meta-regression, percentage of allogeneic HSCT recipients was not associated with each outcome measure. With regard to the comparison between different prophylactic regimens, addition of antibiotics for gram positive bacteria to FQs decreased the incidence of bacteremia (OR 0.44; 0.24-0.80) without significant effects on all-cause mortality, infection related death and febrile episodes. There was not significant, but consistent decrease in clinically or microbiologically documented infection (OR 0.55; 95% CI 0.30-1.01). There was significant increase of adverse events in patients receiving addition of antibiotics for gram positive bacteria to FQs (OR 6.65; 95% CI 2.15-20.54). Conclusions Systemic antibiotic prophylaxis successfully reduced the incidence of infection in HSCT recipients. However, there was no significant impact on mortality. Impact of prophylaxis with FQs on mortality in HSCT recipients was inconclusive because of small number of trials evaluated. Disclosures: No relevant conflicts of interest to declare.

Dose-Dense Chemoimmunotherapy and Early Central Nervous System Prophylaxis For High-Risk Diffuse Large B-Cell Lymphoma. –Preliminary Results From a Nordic Phase II Study

BackgroundDespite the advent of rituximab (R)-based chemoimmunotherapy, outcome for patients with high-risk diffuse large B-cell lymphoma (DLBCL) continues to be suboptimal, and the risk of central nervous system (CNS) progression is high. In a previous Nordic phase II study with dose-dense chemoimmunotherapy followed by systemic CNS prophylaxis, the CNS progression rate was lower than expected (4.5%), but all events occurred within 6 months after initiation of therapy (Holte et al., Ann Oncol 2013). Hence, in the present study, systemic CNS prophylaxis was moved to the beginning of therapy and CNS targeted therapy was further intensified by adding intrathecally administered liposomal AraC. MethodsInclusion criteria are age 18-65 years, primary DLBCL or grade 3B follicular lymphoma without clinical or radiological signs of CNS disease and cytology negative cerebrospinal fluid (CSF), age adjusted IPI 2-3, WHO performance score ≤3, and/or site specific risk factors for CNS recurrence. Treatment consists of two courses of high dose (HD)-Mtx in combination with R-CHOP14, four courses of R-CHOEP14 and a course of HD-AraC with R. In addition, liposomal AraC is administered intrathecally in courses 1, 3 and 5. All courses are administered with support of pegfilgastrim. Indications for radiotherapy are bulky masses at diagnosis and localized PET positive residual disease not eligible for biopsy. Primary endpoints are failure-free survival at 3 years, and CNS progression rate at 18 months. A secondary aim is to elucidate if CSF cytology negative/flow cytometry (FC) positive cases carry an increased risk of CNS progression with the present regimen. ResultsOf the accrued 84 patients by July 22, 2013, 70 had a complete set of baseline data. Median age was 55 years (range 20-64). The majority presented with DLBCL (96%), advanced-stage disease (94%), elevated LDH (94%), B-symptoms (67%), and 49% with >1 extranodal site. Seven CSF-samples were FC positive. Data on toxicity, response and relapse rates were registered for 45 patients. One toxic death due to pneumonia was reported. Grade 4 hematological toxicity and infections were observed in 78% and 11% of the patients, grade 3-4 mucositis and gastrointestinal toxicity in 27% and 42%, and grade 3 arachnoiditis in 2.2% of the patients. CR, CRu, PR and PD rates at the end of chemoimmunotherapy were 69.0%, 14.3%, 14.3% and 2.4 %, respectively. After a median follow up time of 19 months, four patients have relapsed, two of whom with fatal CNS manifestations. ConclusionsPreliminary results indicate highly satisfactory response rates and reasonable toxicity despite intensive therapy. HD-Mtx in combination with R-CHOP in the beginning of therapy and further intensification of treatment with CNS targeted liposomal AraC seem feasible and safe.ClinicalTrials.gov Identifier:NCT01325194 Disclosures:Leppa:Amgen: Research Funding; Mundipharma: Honoraria, Research Funding. Holte:Mundipharma: Honoraria, Research Funding; Amgen: Research Funding.

The Role of Prophylaxis Topical Antibiotics in Cardiac Device Implantation

Combined systemic and topical antibiotic prophylaxes are used in cardiac electronic implantable device (CEID) procedures, but very few studies have assessed prophylactic use of topical antibiotics after CEID implantation. To evaluate the efficacy of topical antibiotic prophylaxis in the prevention of surgical site infection after CEID implantation procedures. This was a prospective randomized, placebo-controlled, single-center, single-operator study. All patients (n = 1,008) received standard systemic antibiotic prophylaxis. Patients were randomized into four groups and received various topical prophylaxes after procedure. All patients were followed for at least 12 months. Surgical site inflammation and infection were graded based on degree of inflammation, discharge, wound culture, and blood culture. Fifty-eight patients developed surgical site inflammation and infection. Fourteen patients had culture-positive wound infections. Among them, 13 patients had superficial wound infections with Staphylococcus species. Only one had pocket infection with Pseudomonas bacteremia. The surgical site infection rate was higher in those with longer procedural time, associated with 2.3 times more likelihood of infection (P = 0.01). Patients with an associated malignancy were associated with 3.6 times more likelihood of infection (P < 0.01). Careful skin preparation prior to incision is important, whereas the use of topical antibiotics after closure has not shown significant benefit. Patients with malignancy and longer procedural times are more likely to develop infection. There is a trend for less infection with cephalic approach. Systemic antibiotics with staphylococcal coverage are needed as most of the wound culture positive infections are caused by Staphylococcus species.

Systematic review of perioperative selective decontamination of the digestive tract in elective gastrointestinal surgery

Studies on selective decontamination of the digestive tract (SDD) in elective gastrointestinal surgery have shown decreased rates of postoperative infection and anastomotic leakage. However, the prophylactic use of perioperative SDD in elective gastrointestinal surgery is not generally accepted. A systematic review of randomized clinical trials (RCTs) was conducted to compare the effect of perioperative SDD with systemic antibiotics (SDD group) with systemic antibiotic prophylaxis alone (control group), using MEDLINE, Embase and the Cochrane Central Register of Controlled Trials. Endpoints included postoperative infection, anastomotic leakage, and in-hospital or 30-day mortality. Eight RCTs published between 1988 and 2011, with a total of 1668 patients (828 in the SDD group and 840 in the control group), were included in the meta-analysis. The total number of patients with infection (reported in 5 trials) was 77 (19.2 per cent) of 401 in the SDD group, compared with 118 (28.2 per cent) of 418 in the control group (odds ratio 0.58, 95 per cent confidence interval 0.42 to 0.82; P = 0.002). The incidence of anastomotic leakage was significantly lower in the SDD group: 19 (3.3 per cent) of 582 patients versus 44 (7.4 per cent) of 595 patients in the control group (odds ratio 0.42, 0.24 to 0.73; P = 0.002). This systematic review and meta-analysis suggests that a combination of perioperative SDD and perioperative intravenous antibiotics in elective gastrointestinal surgery reduces the rate of postoperative infection including anastomotic leakage compared with use of intravenous antibiotics alone.

Comparative effectiveness and cost-benefit analysis of local application of vancomycin powder in posterior spinal fusion for spine trauma

ObjectSurgical site infection (SSI) is a morbid complication with high cost in spine surgery. In this era of health care reforms, adjuvant therapies that not only improve quality but also decrease cost are considered of highest value. The authors introduced local application of vancomycin powder into their practice of posterior spinal fusion for spine trauma and undertook this study to determine the value and cost benefit of using vancomycin powder in surgical sites to prevent postoperative infections.MethodsA retrospective review of 110 patients with traumatic spine injuries treated with instrumented posterior spine fusions over a 2-year period at a single institution was performed. One group (control group) received standard systemic prophylaxis only, whereas another (treatment group) received 1 g of locally applied vancomycin powder (spread over the surgical wound) in addition to systemic prophylaxis. Data were collected on patient demographic characteristics, clinical variables, surgical variables, and 90-day morbidity. Incidence of infection was the primary outcome evaluated, and billing records were reviewed to determine total infection-related medical cost (cost of reoperation/wound debridement, medications, and diagnostic tests). The payer's cost was estimated to be 70% of the total billing cost.ResultsA total of 110 patients were included in the study. The control (n = 54) and treatment groups (n = 56) were similar at baseline. Use of vancomycin powder led to significant reduction in infection rate (13% infection rate in the control group vs 0% in the treatment group, p = 0.02). There were no adverse effects noted from the use of vancomycin powder. The total mean cost of treating postoperative infection per patient was $33,705. Use of vancomycin powder led to a cost savings of $438,165 per 100 posterior spinal fusions performed for traumatic injuries.ConclusionsThe use of adjuvant vancomycin powder was associated with a significant reduction in the incidence of postoperative infection as well as infection-related medical cost. These findings suggest that use of adjuvant vancomycin powder in high-risk patients undergoing spinal fusion is a cost-saving option for preventing postoperative infections, as it can lead to cost-savings of $438,165 per 100 spinal fusions performed.

Cytomegalovirus Infection Prophylaxis Using Lower Dose Valganciclovir in Cardiac Transplant Patients: A Retrospective Analysis of Efficacy and Safety

Cytomegalovirus (CMV) is one of the most common opportunistic infections seen in patients after cardiac transplantation. Systemic prophylaxis is standard of care in all cardiac transplant recipients. Valganciclovir was adopted for its improved bioavailability, and it has now replaced oral ganciclovir for CMV prophylaxis in many centers. The current recommended dosage of valganciclovir for CMV prophylaxis is 900 mg daily for at least 100 days after cardiac transplantation for patients with stable renal function.

Study Design Considerations for Evaluating Efficacy of Systemic Preexposure Prophylaxis Interventions

The development of interventions for systemic pre-exposure prophylaxis (PrEP) faces several significant challenges following the US Food and Drug Administration's approval of emtricitabine/tenofovir (FTC/TDF) for HIV prevention. This development is particularly complex because of inconsistency of efficacy results of FTC/TDF PrEP trials for HIV prevention. Possible designs for a PrEP phase 3 efficacy trial are obtained by considering scenarios for potential experimental PrEP and control regimens, including consideration of placebo and active controls, longer acting PrEP and alternate dosing schedules. Noninferiority (NI) trials with hazard ratio NI margins ranging from 1.10 to 1.25 can be justified in the contexts of the 3 PrEP trials demonstrating efficacy of FTC/TDF. However, these HIV endpoint trials may require extremely large number of participants, particularly in settings where FTC/TDF has been shown to reduce the risk of HIV acquisition. NI trials also are often difficult to interpret because they depend on previous placebo-controlled efficacy results. Superiority trials for PrEP are plausible in settings where FTC/TDF efficacy is not yet established, possibly due to low adherence (ie, women at risk as in FemPrEP and VOICE): a new product with potential for higher adherence and potency would be a promising candidate in this setting. Following Food and Drug Administration's approval of FTC/TDF for PrEP, trials to establish efficacy of new PrEP regimens require stringent design standards, together with rigorous debate about adherence within study populations and many important ethical issues.

Antibiotic prophylaxis for preventing burn wound infection

Infection of burn wounds is a serious problem because it can delay healing, increase scarring and invasive infection may result in the death of the patient. Antibiotic prophylaxis is one of several interventions that may prevent burn wound infection and protect the burned patient from invasive infections. To assess the effects of antibiotic prophylaxis on rates of burn wound infection. In January 2013 we searched the Wounds Group Specialised Register; The Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE; Ovid MEDLINE - In-Process & Other Non-Indexed Citations (2013); Ovid EMBASE; EBSCO CINAHL and reference lists of relevant articles. There were no restrictions with respect to language, date of publication or study setting. All randomised controlled trials (RCTs) that evaluated the efficacy and safety of antibiotic prophylaxis for the prevention of BWI. Quasi-randomised studies were excluded. Two review authors independently selected studies, assessed the risk of bias, and extracted relevant data. Risk ratio (RR) and mean difference (MD) were estimated for dichotomous data and continuous data, respectively. When sufficient numbers of comparable RCTs were available, trials were pooled in a meta-analysis to estimate the combined effect. This review includes 36 RCTs (2117 participants); twenty six (72%) evaluated topical antibiotics, seven evaluated systemic antibiotics (four of these administered the antibiotic perioperatively and three administered upon hospital admission or during routine treatment), two evaluated prophylaxis with non absorbable antibiotics, and one evaluated local antibiotics administered via the airway.The 11 trials (645 participants) that evaluated topical prophylaxis with silver sulfadiazine were pooled in a meta analysis. There was a statistically significant increase in burn wound infection associated with silver sulfadiazine compared with dressings/skin substitute (OR = 1.87; 95% CI: 1.09 to 3.19, I(2) = 0%). These trials were at high, or unclear, risk of bias. Silver sulfadiazine was also associated with significantly longer length of hospital stay compared with dressings/skin substitute (MD = 2.11 days; 95% CI: 1.93 to 2.28).Systemic antibiotic prophylaxis in non-surgical patients was evaluated in three trials (119 participants) and there was no evidence of an effect on rates of burn wound infection. Systemic antibiotics (trimethoprim-sulfamethoxazole) were associated with a significant reduction in pneumonia (only one trial, 40 participants) (RR = 0.18; 95% CI: 0.05 to 0.72) but not sepsis (two trials 59 participants) (RR = 0.43; 95% CI: 0.12 to 1.61).Perioperative systemic antibiotic prophylaxis had no effect on any of the outcomes of this review.Selective decontamination of the digestive tract with non-absorbable antibiotics had no significant effect on rates of all types of infection (2 trials, 140 participants). Moreover, there was a statistically significant increase in rates of MRSA associated with use of non-absorbable antibiotics plus cefotaxime compared with placebo (RR = 2.22; 95% CI: 1.21 to 4.07).There was no evidence of a difference in mortality or rates of sepsis with local airway antibiotic prophylaxis compared with placebo (only one trial, 30 participants). The conclusions we are able to draw regarding the effects of prophylactic antibiotics in people with burns are limited by the volume and quality of the existing research (largely small numbers of small studies at unclear or high risk of bias for each comparison). The largest volume of evidence suggests that topical silver sulfadiazine is associated with a significant increase in rates of burn wound infection and increased length of hospital stay compared with dressings or skin substitutes; this evidence is at unclear or high risk of bias. Currently the effects of other forms of antibiotic prophylaxis on burn wound infection are unclear. One small study reported a reduction in incidence of pneumonia associated with a specific systematic antibiotic regimen.

The role of antibiotic therapy and nasal packing in septoplasty

Both systemic antibiotic therapy and nasal packing are used frequently in septoplasty. Nevertheless, there is still great disagreement among authors around the real advantages with regard to the efficacy of both of these procedures in septal surgery. The aim of the present review was to evaluate the more recent data published on this topic. One appropriate string was run on PubMed to retrieve articles dealing with the topics mentioned above. A double cross-check was performed on citations and full-text articles found using the selected inclusion and exclusion criteria. Overall, the articles we analyzed indicated the poor utility of routine antibiotic therapy and nasal packing during septoplasty, the latter procedure producing more complications than advantages. In conclusion, on the basis of the recent literature, the use of systemic antibiotic prophylaxis and nasal packing in septal surgery seems to be a non-rational procedure.