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Prophylaxis of Wound Infections-antibiotics in Renal Donation (POWAR): A UK Multicentre Double Blind Placebo Controlled Randomised Trial.
Ahmed, Z, Uwechue, R, Chandak, P, van Dellen, D, Barwell, J, Heap, S, Szabo, L, Hemsley, C, Olsburgh, J, Kessaris, N, et al
Annals of surgery. 2020;(1):65-71
Abstract
BACKGROUND Postoperative infection after hand-assisted laparoscopic donor nephrectomy (HALDN) confers significant morbidity to a healthy patient group. Current UK guidelines cite a lack of evidence for routine antibiotic prophylaxis. This trial assessed if a single preoperative antibiotic dose could reduce post HALDN infections. METHODS Eligible donors were randomly and blindly allocated to preoperative single-dose intravenous co-amoxiclav or saline. The primary composite endpoint was clinical evidence of any postoperative infection at 30 days, including surgical site infection (SSI), urinary tract infection (UTI), and lower respiratory tract infection (LRTI). FINDINGS In all, 293 participants underwent HALDN (148 antibiotic arm and 145 placebo arm). Among them, 99% (291/293) completed follow-up. The total infection rate was 40.7% (59/145) in the placebo group and 23% (34 of 148) in the antibiotic group (P = 0.001). Superficial SSIs were 20.7% (30/145 patients) in the placebo group versus 10.1% (15/148 patients) in the antibiotic group (P = 0.012). LRTIs were 9% (13/145) in the placebo group and 3.4% (5/148) in the antibiotic group (P = 0.046). UTIs were 4.1% (6/145) in the placebo group and 3.4% (5/148) in the antibiotic group (P = 0.72).Antibiotic prophylaxis conferred a 17.7% (95% confidence interval 7.2%-28.1%), absolute risk reduction in developing postoperative infection, with 6 donors requiring treatment to prevent 1 infection. INTERPRETATION Single-dose preoperative antibiotic prophylaxis dramatically reduces post-HALDN infection rates, mainly impacting SSIs and LRTIs.
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Does an Antimicrobial Incision Drape Prevent Intraoperative Contamination? A Randomized Controlled Trial of 1187 Patients.
Hesselvig, AB, Arpi, M, Madsen, F, Bjarnsholt, T, Odgaard, A, ,
Clinical orthopaedics and related research. 2020;(5):1007-1015
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Abstract
BACKGROUND The risk of periprosthetic joint infection (PJI), a serious complication after arthroplasty, has not changed for years. Interventions such as eradication of Staphylococcus aureus and antibiotic bone cement are used to diminish infection risk but despite these efforts, the percentage of infection in TKA remains constant. Antimicrobial drapes have a dual action, acting both as a physical and antimicrobial barrier to counter bacterial contamination of the surgical wound. To study the effect of antimicrobial drapes, we used intraoperative contamination as a proxy for infection in our investigation. QUESTIONS/PURPOSES (1) Do antimicrobial surgical drapes reduce the risk of intraoperative microbial contamination in patients undergoing primary knee arthroplasty? (2) Are other factors such as sex, season, age, type of arthroplasty and duration of surgery associated with an increased risk of contamination in patients undergoing primary knee arthroplasty? (3) Does loosening of the antimicrobial drape increase contamination risk? METHODS An investigator-initiated, two-arm, non-blinded, multicenter, randomized, controlled trial was performed at five different hospitals in the capital and central regions of Denmark. Twenty-four surgeons participated in the study. Participants were patients older than 18 years undergoing primary knee arthroplasty. We excluded patients with an iodine allergy, previous open knee surgery, previous septic arthritis, any antibiotics taken 4 weeks before surgery, and if they were unable to understand the implications of study participation. Patients were randomly assigned to operation with an antimicrobial drape (intervention group) or operation without (control group). We screened 1769 patients, of which 100 were ineligible and 10 declined to participate. In all, 94% (1659 of 1769) of patients consented and were randomized to the intervention group (51%, 838 of 1659) and control group (49%, 821 of 1659), respectively. In all, 36% (603 of 1659) of patients in the intervention group and 35% (584 of 1659) patients in the control group were available for final analysis. No crossover was performed, and analysis was done per-protocol. Patients were excluded due to logistic failures like lack of utensils, samples disappearing en route to the laboratory mainly caused by implementation of a new electronic patient chart (EPIC, Verona, WI, USA), and forgetful surgeons. Intraoperatively, we swabbed for bacteria at the surgical site and in a rinse from the surgeons' gloves. All samples were sent for cultivation, and colony forming units (CFUs) counts ≥ 1 were deemed contaminated. The primary outcome measure was the difference in the proportion of contaminated patients between the two randomized groups. Secondary outcome measures were the affiliation of sex, season, age, type of implant used, and duration of surgery on contamination risk. To investigate whether other factors were affiliated with contamination risk, we did a logistic regression to control for confounding variables, including sex, age, season, type of implant and duration of surgery. RESULTS Use of iodinated drapes reduced contamination, with contamination detected in 10% (60 of 603) procedures where iodinated drapes were used compared with 15% (90 of 584) when they were not (odds ratio 0.61 [95% CI 0.43 to 0.87]; p = 0.005), with a relative risk reduction of 35% (95% CI 12.3 to 52.5) and a number needed to treat of 18 patients. After controlling for confounding variables such as sex, age, type of implant, and duration of surgery, we found that not using an antimicrobial drape increased contamination risk by a factor of 1.6 (95% CI 1.08 to 2.35; p = 0.02). Female sex and undergoing surgery in the central region were associated with lower odds of contamination (OR 0.55 [95% CI 0.39 to 0.8]; p = 0.002 and OR 0.45 [95% CI 0.25 to 0.8]; p = 0.006, respectively). Patients with more than a 10-mm separation of the drape from the skin had higher odds of contamination (OR 3.54 [95% CI 1.64 to 11.05]; p = 0.0013). CONCLUSIONS The use of an antimicrobial drape resulted in lower contamination risk than operating without an antimicrobial drape. Our findings suggest that antimicrobial drapes are useful in infection prevention, but further studies are needed to investigate the effect of antimicrobial drapes on infection. LEVEL OF EVIDENCE Level I, therapeutic study.
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Comparison of olanexidine versus povidone-iodine for preventing surgical site infection in gastrointestinal surgery: study protocol for a multicentre, single-blind, randomised controlled clinical trial.
Takeuchi, M, Obara, H, Kawakubo, H, Shinoda, M, Okabayashi, K, Mayanagi, S, Irino, T, Fukuda, K, Nakamura, R, Wada, N, et al
BMJ open. 2019;(5):e028269
Abstract
INTRODUCTION The prevalence of surgical site infection (SSI) remains higher in gastrointestinal surgery than in other surgeries. Although several guidelines have indicated the efficacy of chlorhexidine and povidone-iodine in reducing the SSI rate, the optimal recommendation has still not been established. Therefore, it is necessary to determine the more effective antiseptic for surgical site preparation. Olanexidine (1.5% olanedine, Otsuka Pharmaceutical Factory, Tokushima, Japan), which is a new antiseptic in Japan, has antimicrobial activity against a wide range of bacteria, including Gram-positive and Gram-negative bacteria. Our study will contribute to determining a new antiseptic for use in gastrointestinal and other surgeries. METHODS AND ANALYSIS We propose a multicentre, randomised controlled clinical trial for comparing two treatments, that is, 1.5% olanexidine or 10% povidone-iodine, for surgical skin preparation to prevent SSI in clean-contaminated gastrointestinal surgeries with surgical wounds. Patients aged ≥20 years at the time of consent will be included. The primary outcome measure is the 30-day postoperative SSI rate. For the primary analysis, which is aimed at comparing the treatment effects, the adjusted risk ratio and its 95% CI will be estimated using the Mantel-Haenszel method. ETHICS AND DISSEMINATION The protocol was first approved by the Institutional Review Board of Keio University School of Medicine, followed by the institutional review board of each participating site. Participant recruitment began in June 2018. The final results will be published in international peer-reviewed medical journals. TRIAL REGISTRATION NUMBER UMIN 000031560; Pre-results.
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Steroids in cardiac surgery trial: a substudy of surgical site infections.
McClure, GR, Belley-Cote, EP, Harlock, J, Lamy, A, Stacey, M, Devereaux, PJ, Whitlock, RP
Canadian journal of anaesthesia = Journal canadien d'anesthesie. 2019;(2):182-192
Abstract
PURPOSE Postoperative infection, particularly in cardiac surgery, results in significant morbidity, mortality, and healthcare cost. Identification of novel predictors of postoperative infection can target high-risk populations for prophylactic intervention. METHODS Steroids in cardiac surgery (SIRS) was a multi-centre randomized-controlled trial assessing intraoperative administration of methylprednisone during cardiac surgery, which enrolled 7,507 patients across 80 centres in 18 countries. It demonstrated that administration of steroids had no effect on mortality or major morbidity after cardiac surgery. Our primary objective was to identify risk factors for postoperative surgical site infections using SIRS participants as a cohort. We excluded patients who did not undergo surgery, died intraoperatively, or died within 48 hr of the operation. Patients were assessed for development of "surgical site infection" over the first 30 days postoperatively. Using theoretical and previously identified risk factors, we used forward stepwise entry to create a binary logistic regression model. RESULTS Follow-up at 30 days was complete for all patients; 7,406 were included in the cohort. Surgical site infection occurred in 180 (4.8%) and 184 (5.0%) of patients in the placebo and steroid arms respectively. Significant risk factors (P < 0.05 level) included: diabetes managed with insulin (adjusted odds ratio [aOR]: 1.55; 95% confidence interval [CI] 1.13 to 2.12), oral hypoglycemics (aOR 1.60; 95% CI 1.18 to 2.16), or diet (aOR 1.81; 95% CI 1.16 to 2.83), female sex (aOR 1.34; 95% CI 1.05 to 1.71), renal failure with (aOR 2.03; 95% CI 1.06 to 3.91), and without (aOR 1.50; 95% CI 1.04 to 2.14) dialysis, > 96 min cardiopulmonary bypass (CPB) time (aOR 1.84; 95% CI 1.44 to 2.35), body mass index (BMI) < 22.3 (aOR 0.44; 95% CI 0.28 to 0.71) or > 30 (aOR 1.49; 95% CI 1.17 to 1.89), peak intensive care unit blood glucose (aOR 1.02 per mmol·L-1; 95% CI 1.00 to 1.04), and coronary artery bypass grafting (CABG) operation type (aOR 2.59; 95% CI 1.87 to 3.59). CONCLUSIONS Patients undergoing CABG, requiring longer CPB, with higher BMI, or with diabetes, are at elevated risk of surgical site infection. Strategies to mitigate this risk warrant further investigation.
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Predicting and Preventing Loss to Follow-up of Adult Trauma Patients in Randomized Controlled Trials: An Example from the FLOW Trial.
Madden, K, Scott, T, McKay, P, Petrisor, BA, Jeray, KJ, Tanner, SL, Bhandari, M, Sprague, S
The Journal of bone and joint surgery. American volume. 2017;(13):1086-1092
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BACKGROUND High loss-to-follow-up rates are a risk in even the most rigorously designed randomized controlled trials (RCTs). Consequently, predicting and preventing loss to follow-up are important methodological considerations. We hypothesized that certain baseline characteristics are associated with a greater likelihood of patients being lost to follow-up. Our primary objective was to determine which baseline characteristics are associated with loss to follow-up within 12 months after an open fracture in adult patients participating in the Fluid Lavage of Open Wounds (FLOW) trial. We also present strategies to reduce loss to follow-up in trauma trials. METHODS Data for this study were derived from the FLOW trial, a funded trial in which payments to clinical sites were tied to participant retention. We conducted a binary logistic regression analysis with loss to follow-up as the dependent variable to determine participant characteristics associated with a higher risk of loss to follow-up. RESULTS Complete data were available for 2,381 of 2,447 participants. One hundred and sixty-three participants (6.7%) were lost to follow-up. Participants who received treatment in the U.S. were more likely to be lost to follow-up than those who received treatment in other countries (odds ratio [OR] = 3.56, 95% confidence interval [CI]: 2.46 to 5.17, p < 0.001). Male sex (OR = 1.75, 95% CI: 1.15 to 2.67, p = 0.009), current smoking (OR = 1.82, 95% CI: 1.28 to 2.58, p = 0.001), high-risk alcohol consumption (OR = 1.88, 95% CI: 1.16 to 3.05, p = 0.010), and an age of <30 years (OR = 2.16, 95% CI: 1.19 to 3.95, p = 0.012) all significantly increased the odds of a patient being lost to follow-up. Conversely, participants who had sustained polytrauma (OR = 0.52, 95% CI: 0.37 to 0.73, p < 0.001) or had a Gustilo-Anderson type-IIIA, B, or C fracture (OR = 0.60, 95% CI: 0.38 to 0.94, p = 0.024) had lower odds of being lost to follow-up. CONCLUSIONS Using a number of strategies, we were able to reduce the loss-to-follow-up rate to <7%. Males, current smokers, young participants, participants who consumed a high-risk amount of alcohol, and participants in the U.S. were more likely to be lost to follow-up even after these strategies had been employed; therefore, additional strategies should be developed to target these high-risk participants. CLINICAL RELEVANCE This study highlights an important need to develop additional strategies to minimize loss to follow-up, including targeted participant-retention strategies. Male sex, an age of <30 years, current smoking, high-risk alcohol consumption, and treatment in a developed country with a predominantly privately funded health-care system increased the likelihood of participants being lost to follow-up. Therefore, strategies should be targeted to these participants. Use of the planning and prevention strategies outlined in the current study can minimize loss to follow-up in orthopaedic trials.
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Reduced infections with perioperative immunonutrition in head and neck cancer: exploratory results of a multicenter, prospective, randomized, double-blind study.
Falewee, MN, Schilf, A, Boufflers, E, Cartier, C, Bachmann, P, Pressoir, M, Banal, A, Michel, C, Ettaiche, M
Clinical nutrition (Edinburgh, Scotland). 2014;(5):776-84
Abstract
BACKGROUND & AIMS Head and neck cancer surgery is affected by complications in 20-60% of cases, with risk factors being malnutrition, alcoholism and immunosuppression due to cancer. The aim of the study was to investigate whether preoperative or perioperative immunonutrition could reduce postoperative infectious complications (IC) and surgical-site infections (SSI) in this population. METHODS This was a multicenter, prospective, randomized, double-blind study. Patients with oropharyngeal and pharyngolaryngeal tumour were randomly allocated to three groups: a) perioperative formula of Impact(®) without immune nutrients, named "reference diet" (group A, control); b) preoperative Impact(®) and "reference diet" postoperatively (group B); c) Impact(®) perioperatively (group C). Products were available in oral and enteral formula and were given 7 days before surgery and for 7-15 days postoperatively. The primary and secondary endpoints were the incidence of IC and SSI, respectively. RESULTS Of 312 randomized patients, 205 were evaluable for ITT analysis. There was no significant difference in IC and SSI. However out of this population, only 64 patients had taken at least 75% of the theoretical intake from surgery to day 10 (per-protocol population). In this condition, a significant difference in IC (OR = 0.24, p = 0.05), SSI (OR = 0.17, p = 0.04) and also in the median length of postoperative stay (18 vs. 25 days, p = 0.05) was demonstrated between groups A and C. CONCLUSIONS In the ITT population, no significant difference in IC, SSI and LOS was demonstrated. Positive exploratory results on the perioperative Impact(®) per-protocol population, encourage further study in head and neck cancer patients. Registered under ClinicalTrials.gov Identifier no. NCT00765440.
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Effect of an investigational vaccine for preventing Staphylococcus aureus infections after cardiothoracic surgery: a randomized trial.
Fowler, VG, Allen, KB, Moreira, ED, Moustafa, M, Isgro, F, Boucher, HW, Corey, GR, Carmeli, Y, Betts, R, Hartzel, JS, et al
JAMA. 2013;(13):1368-78
Abstract
IMPORTANCE Infections due to Staphylococcus aureus are serious complications of cardiothoracic surgery. A novel vaccine candidate (V710) containing the highly conserved S. aureus iron surface determinant B is immunogenic and generally well tolerated in volunteers. OBJECTIVE To evaluate the efficacy and safety of preoperative vaccination in preventing serious postoperative S. aureus infection in patients undergoing cardiothoracic surgery. DESIGN, SETTING, AND PARTICIPANTS Double-blind, randomized, event-driven trial conducted between December 2007 and August 2011 among 8031 patients aged 18 years or older who were scheduled for full median sternotomy within 14 to 60 days of vaccination at 165 sites in 26 countries. INTERVENTION Participants were randomly assigned to receive a single 0.5-mL intramuscular injection of either V710 vaccine, 60 μg (n = 4015), or placebo (n = 4016). MAIN OUTCOME MEASURES The primary efficacy end point was prevention of S. aureus bacteremia and/or deep sternal wound infection (including mediastinitis) through postoperative day 90. Secondary end points included all S. aureus surgical site and invasive infections through postoperative day 90. Three interim analyses with futility assessments were planned. RESULTS The independent data monitoring committee recommended termination of the study after the second interim analysis because of safety concerns and low efficacy. At the end of the study, the V710 vaccine was not significantly more efficacious than placebo in preventing either the primary end points (22/3528 V710 vaccine recipients [2.6 per 100 person-years] vs 27/3517 placebo recipients [3.2 per 100 person-years]; relative risk, 0.81; 95% CI, 0.44-1.48; P = .58) or secondary end points despite eliciting robust antibody responses. Compared with placebo, the V710 vaccine was associated with more adverse experiences during the first 14 days after vaccination (1219/3958 vaccine recipients [30.8%; 95% CI, 29.4%-32.3%] and 866/3967 placebo recipients [21.8%; 95% CI, 20.6%-23.1%], including 797 [20.1%; 95% CI, 18.9%-21.4%] and 378 [9.5%; 95% CI, 8.6%-10.5%] with injection site reactions and 66 [1.7%; 95% CI, 1.3%-2.1%] and 51 [1.3%; 95% CI, 1.0%-1.7%] with serious adverse events, respectively) and a significantly higher rate of multiorgan failure during the entire study (31 vs 17 events; 0.9 [95% CI, 0.6-1.2] vs 0.5 [95% CI, 0.3-0.8] events per 100 person-years; P = .04). Although the overall incidence of vaccine-related serious adverse events (1 in each group) and the all-cause mortality rate (201/3958 vs 177/3967; 5.7 [95% CI, 4.9-6.5] vs 5.0 [95% CI, 4.3-5.7] deaths per 100 person-years; P = .20) were not statistically different between groups, the mortality rate in patients with staphylococcal infections was significantly higher among V710 vaccine than placebo recipients (15/73 vs 4/96; 23.0 [95% CI, 12.9-37.9] vs 4.2 [95% CI, 1.2-10.8] per 100 person-years; difference, 18.8 [95% CI, 8.0-34.1] per 100 person-years). CONCLUSIONS AND RELEVANCE Among patients undergoing cardiothoracic surgery with median sternotomy, the use of a vaccine against S. aureus compared with placebo did not reduce the rate of serious postoperative S. aureus infections and was associated with increased mortality among patients who developed S. aureus infections. These findings do not support the use of the V710 vaccine for patients undergoing surgical interventions. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00518687.
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Comparison of rate of surgical wound infection, length of hospital stay and patient convenience in complicated appendicitis between primary closure and delayed primary closure.
Khan, KI, Mahmood, S, Akmal, M, Waqas, A
JPMA. The Journal of the Pakistan Medical Association. 2012;(6):596-8
Abstract
OBJECTIVE To compare the difference in the rate of surgical wound infection, patient's convenience and length of hospital stay between Primary Closure and Delayed Primary Closure in cases of complicated appendicitis in adults. METHODS This randomised control trial was conducted at the Combined Military Hospital, Kharian and Malir from June 5, 2006, to September 10, 2009. Patients > or = 15 years of both gender who underwent appendectomy through grid iron or Lanz incision and having complicated appendicitis were included. The 100 patients who were included in the study out of the initial size of 393, were randomised into two equal groups of 50 each (Group A: Primary Closure; Group B: Delayed Primary Closure) using a computer-generated table. All the surgeries were done by the same surgeon and the operative steps and antibiotic coverage were standardised. The rate of surgical wound infection, patient's convenience (on visual analogue scale in mm) and the length of hospital stay were recorded. Data was analysed using SPSS version 11, and p value was calculated. RESULTS Demographic data, comorbids and medication of both the groups was comparable. There was no significant difference in rate of surgical wound infection (p > 0.05). The difference in patient's convenience and length of hospital stay were significant (p < 0.05), showing superiority of Primary Closure over Delayed Primary Closure with no added morbidity/mortality. CONCLUSION Primary Closure in complicated appendicitis not only reduces the cost of treatment, but is also more convenient and satisfying for the patients, with no added risk of surgical wound infection.
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[Proctological surgery: use of a salsobromoiodic gel solution in the post-operative period].
Gaj, F, Sportelli, G, Veltri, S, Crispino, P
La Clinica terapeutica. 2009;(2):111-3
Abstract
BACKGROUND This study was aimed to demonstrate the advantages and the efficacy of a salsobromoiodic gel solution sponge to use in coloproctology after surgery for the most frequent pathologies of anal canal and of perineal region. MATERIALS AND METHODS The Authors have tested the salsobromoiodic gel solution (Fertomcidina U) in a consecutive series of patients referred to 5 coloproctological centers where they have been submitted to surgery for pathologies of anal canal and of perineal region. A total of 30 patients, 15 with clinico-instrumental diagnosis of III-IV degree haemorrhoids and 15 with diagnosis of chronic anal fissure entered in a clinical follow-up after an out-patient setting or surgery for the respective pathologies. The gel formulation is realized as a salsobromoiodic solution containing salicylic acid and magnesium biphosphate making a strong bactericide and fungicide action applicable on human skin for tissues reparation and their re-epithelization. The experimental treatment was performed on the duration of at least 10 days, with two topic applications. RESULT In 100% of the treated patients, the used gel has determined the prevention of infective complications, favouring a normal re-epithelization of tissue submitted to surgery or affected by previous anal mucosal lesions. The use of gel has not caused irritation and skin damage. No symptom and sign of toxicity were observed. CONCLUSIONS The use of salsobromoiodic gel solution has been useful to prevent infections and to contribute to the cicatrisation, healing and re-epithelization of anal mucosal lesions after surgery on a normal outpatients setting. The use of gel formulation resulted easy and satisfactory for the patients affected by the most frequent proctological pathologies which require a surgical treatment.
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Antibiotic prophylaxis in percutaneous endoscopic gastrostomy (PEG)--results from a prospective randomized multicenter trial.
Dormann, AJ, Wigginghaus, B, Risius, H, Kleimann, F, Kloppenborg, A, Rosemann, J, Padel, Y, Pohl, R, Baum, HH, Lübbesmeier, A, et al
Zeitschrift fur Gastroenterologie. 2000;(3):229-34
Abstract
OBJECTIVE To determine the efficacy of antibiotic prophylaxis in percutaneous endoscopic gastrostomy (PEG) as a part of a standardized regimen. METHODS An open prospective randomised multicenter study in 216 patients. 106 received ceftriaxone 1 g i.v. 30 min preinterventionally and 110 no study medication. A standardized protocol was followed for PEG preparation, insertion, and aftercare; all patients received a 15 French gastrostomy tube. Follow-up of local and systemic infection and clinical course was continued to postintervention day 10. An aggregate erythema and exudation score > 3 or the presence of pus was taken as indicative of peristomal infection. The pharmacoeconomics of antibiotic use were also examined. RESULTS In no-prophylaxis patients, wound infection rates were 23.6% on day 4 and 24.5% on day 10 vs. 7.6% (p < 0.05) and 11.4% (p < 0.05), respectively, in prophylaxis patients. Results were disproportionally better in tumor patients in comparison with neurological patients. Patients systemic infection rates were 11.8% vs. 1.9% in noprophylaxis vs. prophylaxis (p < 0.05), and overall infection rates 36.3% vs. 13.3%, respectively (p < 0.05). Pneumonia was more frequent in patients with underlying neurological disease and reduced in the prophylaxis group. Antibiotic and application costs were similar in both groups (p = 0.400). CONCLUSIONS Single-dose ceftriaxone 1 g is a effective prophylaxis against local and systemic infection after PEG and should be a part of a standard regimen.