Dataset Information

Wound Infections Following Implant removal below the knee: the effect of antibiotic prophylaxis; the WIFI-trial, a multi-centre randomized controlled trial.

ABSTRACT: In the Netherlands about 18,000 procedures with implant removal are performed annually following open or closed reduction and fixation of fractures, of which 30-80% concern the foot, ankle and lower leg region. For clean surgical procedures, the rate of postoperative wound infections (POWI) should be less than ~2%. However, rates of 10-12% following implant removal have been reported, specifically after foot, ankle and lower leg fractures. Currently, surgeons individually decide if antibiotics prophylaxis is given, since no guideline exists. This leads to undesirable practice variation. The aim of the study is to assess the (cost-)effectiveness of a single intravenous gift of Cefazolin prior to implant removal following surgical fixation of foot, ankle and/or lower leg fractures.This is a double-blind randomized controlled trial in patients scheduled for implant removal following a foot, ankle or lower leg fracture. Primary outcome is a POWI within 30 days after implant removal. Secondary outcomes are quality of life, functional outcome and costs at 30 days and 6 months after implant removal. With 2 x 250 patients a decrease in POWI rate from 10% to 3.3% (expected rate in clean-contaminated elective orthopaedic trauma procedures) can be detected (Power?=?80%, 2-sided alpha?=?5%, including 15% lost to follow up).If administration of prophylactic antibiotics prior to implant removal reduces the infectious complication rate, this will offer a strong argument to adopt this as standard practice of care. This will consequently lead to less physical and social disabilities and health care use. A preliminary, conservative estimation suggests yearly cost savings in the Netherlands of € 3.5 million per year.This study is registered at Clinicaltrials.gov ( NCT02225821 ) and the Netherlands Trial Register ( NTR4393 ) and was granted permission by the Medical Ethical Review Committee of the Academic Medical Centre on October 7 2014.

SUBMITTER: Backes M

PROVIDER: S-EPMC4429659 | biostudies-literature | 2015 Feb

REPOSITORIES: biostudies-literature

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Wound Infections Following Implant removal below the knee: the effect of antibiotic prophylaxis; the WIFI-trial, a multi-centre randomized controlled trial.

Backes Manouk M Dingemans Siem A SA Schep Niels W L NW Bloemers Frank W FW Van Dijkman Bart B Garssen Frank P FP Haverlag Robert R Hoogendoorn Jochem M JM Joosse Pieter P Mirck Boj B Postma Victor V Ritchie Ewan E Roerdink W Herbert WH Sintenie Jan Bernard JB Soesman Nicolaj M R NM Sosef Nico L NL Twigt Bas A BA Van Veen Ruben N RN Van der Veen Alexander H AH Van Velde Romuald R Vos Dagmar I DI De Vries Mark R MR Winkelhagen Jasper J Goslings J Carel JC Schepers Tim T

BMC surgery 20150206

<h4>Background</h4>In the Netherlands about 18,000 procedures with implant removal are performed annually following open or closed reduction and fixation of fractures, of which 30-80% concern the foot, ankle and lower leg region. For clean surgical procedures, the rate of postoperative wound infections (POWI) should be less than ~2%. However, rates of 10-12% following implant removal have been reported, specifically after foot, ankle and lower leg fractures. Currently, surgeons individually deci ...[more]

PMID: 25972101

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Project description:Introduction:Resistant Gram-positive organisms, such as methicillin-resistant staphylococci, account for a significant proportion of infections following joint replacement surgery. Current surgical antimicrobial prophylaxis guidelines recommend the use of first-generation or second-generation cephalosporin antibiotics, such as cefazolin. Cefazolin, however, does not prevent infections due to these resistant organisms; therefore, new prevention strategies need to be examined. One proposed strategy is to combine a glycopeptide antibiotic with cefazolin for prophylaxis. The clinical benefit and cost-effectiveness of this combination therapy compared with usual therapy, however, have not been established.Methods and analysis:This randomised, double-blind, parallel, superiority, placebo-controlled, phase 4 trial will compare the incidence of all surgical site infections (SSIs) including superficial, deep and organ/space (prosthetic joint) infections, safety and cost-effectiveness of surgical prophylaxis with cefazolin plus vancomycin to that with cefazolin plus placebo. The study will be performed in patients undergoing joint replacement surgery. In the microbiological sub-studies, we will examine the incidence of SSIs in participants with preoperative staphylococci colonisation (Sub-Study 1) and incidence of VRE acquisition (Sub-Study 2). The trial will recruit 4450 participants over a 4-year period across 13 orthopaedic centres in Australia. The primary outcome is the incidence of SSI at 90 days post index surgery. Secondary outcomes include the incidence of SSI according to joint and microorganism and other healthcare associated infections. Safety endpoints include the incidence of acute kidney injury, hypersensitivity reactions and all-cause mortality. The primary and secondary analysis will be a modified intention-to-treat analysis consisting of all randomised participants who undergo eligible surgery. We will also perform a per-protocol analysis.Ethics and dissemination:The study protocol was reviewed and approved by The Alfred Hospital Human Research Ethics Committee (HREC/18/Alfred/102) on 9 July 2018. Study findings will be disseminated in the printed media, and learnt forums.Trial registration number:ACTRN12618000642280.

Project description:BackgroundThe prescription of prophylactic antibiotics in conjunction with oral implant surgery remains inconsistent among different populations of dentists. The main objective of this study was to assess the current antibiotic prescribing habits of dentist in conjunction with oral implant surgery in Italy. The secondary objective was to assess the nature and amount (mg) of antibiotics prescriptions in order to evaluate whether any consensus has been reached and if the current recommendations are complied.MethodsObservational cross-sectional study based on a web-survey reported according to the STROBE guidelines. A questionnaire was sent via email to each registered member of the Italian Academy of Osseointegration (n?=?400). The email included a link to the anonym web questionnaire developed on www.encuestafacil.com. It contained close-ended and some open-ended questions concerning demographics, antibiotic type, prescription duration and dosage. Collected data were analyzed using STATA® 14 software.Results160 participants responded the survey (response rate?=?40%). Approximately 84% routinely prescribed prophylactic antibiotics in conjunction with oral implant surgery, 15.6% prescribed antibiotics in certain situations and only 1 did not prescribe antibiotics at all. Overall, 116 respondents prescribed both pre- and postoperative antibiotics, 29 prescribed antibiotics only preoperatively and 14 prescribed antibiotics exclusively after surgery. Italian dentists prescribed an average amount of 10,331?mg antibiotics before, during or after oral implant surgery. Approximately, only 17% (n?=?27) of the participants who prescribed antibiotics before oral implant surgery complied with the recommendations proposed by the latest publications (no more than 3?g of preoperative amoxicillin before oral implant surgery).ConclusionsDentists in Italy on a large scale prescribe antibiotic prophylaxis in conjunction with oral implant surgery among healthy patients. A high range of prophylactic regimens is prescribed and they are not adhering to the new science-based specifications. Guidelines focused on the indications for prophylactic antibiotics among healthy patients are required to prevent bacterial resistance, side effects and costs caused by overtreatment and the irrational use of antibiotics.

Project description:BACKGROUND:There seems to be no consensus on the prescription of prophylactic antibiotics in oral implant surgery. The Dutch Association of Oral Implantology (NVOI) guidelines do not include a clear policy on prophylactic antibiotic prescriptions for oral implant surgery among healthy patients. The purpose of the study was to determine whether antibiotic prophylaxis is commonly prescribed in the Netherlands by general dentists, maxillofacial surgeons and oral implantologists in conjunction with oral implant surgery among healthy patients and to assess the type and amount of prophylactic antibiotic prescribed. METHODS:This observational cross-sectional study is based on a web survey. A questionnaire developed in the United States of America was translated and slightly adjusted for use in the Netherlands. It contained predominantly close-ended questions relating to demographics, qualifications, antibiotic type, prescription duration and dosage. An email including an introduction to the study and an individual link to the questionnaire was sent in February 2018 to a sample of 600 general dental practitioners and all 302 specialized dentists (oral implantologists, periodontists and maxillofacial surgeons) recognized by the NVOI. Overall, 902 questionnaires were anonymously sent. Finally, 874 potential participants were reached. Collected data were analyzed through descriptive statistics. RESULTS:In total, 218 (24.9%) participants responded to the questionnaire, including 45 females (20.8%) and 171 males (79.2%). Overall, 151 (69.9%) regularly placed oral implants. Of them, 79 (52.7%) prescribe antibiotics only in specific situations, 66 (43.7%) regularly, and 5 (3.3%) did not prescribe antibiotics at all. Overall, 83 participants who prescribe antibiotics did so both pre- and postoperatively (57.2%), 47 only preoperatively (32.4%) and 12 exclusively postoperatively (8.3%). A single dose of 2000 mg of amoxicillin orally one hour prior to surgery was the most prescribed preoperative regimen. The most frequently prescribed postoperative regimen was 500 mg of amoxicillin three times daily for five days after surgery. On average, participants prescribe a total of 7018 mg of antibiotics before, during or after oral implant surgery. CONCLUSIONS:Antibiotic prophylaxis in conjunction with oral implant surgery is prescribed in the Netherlands on a large scale, and recommendations based on the last published evidence are frequently not followed.

Project description:BackgroundRecent meta-analyses concluded that antibiotic prophylaxis is not warranted in low-risk laparoscopic cholecystectomy. However, most trials in the meta-analyses had a relatively small sample size and were statistically underpowered. In addition, many of the trials mentioned potential cost savings owing to the elimination of prophylactic antibiotics. However, no trial has statistically estimated the cost effectiveness. To evaluate the results of meta-analyses, we conducted a randomized controlled trial on the role of prophylactic antibiotics in low-risk laparoscopic cholecystectomy with an adequate sample size.MethodsFrom March 2007 to May 2013, at the Department of Surgery, Kansai Medical University, patients who were scheduled for elective laparoscopic cholecystectomy were randomly assigned to one of two arms: those who were and were not administered prophylactic antibiotics. The primary endpoint was the occurrence of postoperative infections and secondary endpoints were postoperative hospital stay and medical costs.FindingsDuring the study period, 518 patients were assigned to the Antibiotics group and 519 to the No antibiotics group. Occurrences of surgical site infections, distant infections and overall infections were significantly lower in the Antibiotics group than in the No antibiotics group (0.8 vs. 3.7%, p?=?0.001, OR: 0.205 (95%CI: 0.069 to 0.606); 0.4 vs. 3.1%, p?=?0.0004, OR: 0.122 (95%CI: 0.028 to 0.533); 1.2 vs. 6.7%; p<0.0001, OR: 0.162 (95%CI: 0.068 to 0.389), respectively). The postoperative hospital stay was significantly shorter in the Antibiotics group (mean, SD: 3.69±1.56 vs. 4.07±3.00; p?=?0.01) and the postoperative medical costs were significantly lower in the Antibiotics group (mean, SD: $766±341 vs. 832±670; p?=?0.047). Multivariable analysis showed that independent risk factors for postoperative infectious complications were no prophylactic antibiotics (p<0.0001) and age 65 or older (p?=?0.006).ConclusionsPerioperative administration of prophylactic antibiotics should be recommended in laparoscopic cholecystectomy to prevent postoperative infectious complications and to reduce medical costs.Trial registrationUMIN Clinical Trials Registry UMIN000003749.

Project description:BackgroundRagged placental membranes is a distinct entity from retained placenta and not uncommonly reported in midwifery texts. Although the incidence of postpartum endometritis is merely 1-5% after vaginal births, it remains the most common source of puerperal sepsis, contributing up to 15% of maternal mortality in low income countries. Geographically-remote centres in Malaysia prophylactically administer antibiotics for women with ragged placental membranes after vaginal birth, extrapolating evidence from retained placenta. We sought to clarify the rationale in continuing such practices.MethodsThis was an open-label, prospective, multicentre, randomized trial. Three hospitals where the current protocol was to administer prophylactic amoxycillin-clavulanic acid served as the sites of recruitment. Women who delivered vaginally beyond 24+ 0 weeks of gestation with ragged membranes were invited to participate in the trial and randomized into prophylaxis or expectant management with medical advice by blocks of 10, at a 1:1 ratio. A medication adherence diary was provided and patients followed up at 2 weeks and 6 weeks postpartum.ResultsA total of 6569 women gave birth vaginally in three centres during the trial period, of which 10.9% had ragged membranes. The incidence of endometritis was not significantly raised in women with or without prophylaxis (0.90% vs 0.29%; p = 0.60). All cases of endometritis presented within the first 2 weeks and preventive use of antibiotics did not ameliorate the severity of endometritis since rates of ICU admission, surgical evacuation and transfusion were comparable.ConclusionPreventive use of antibiotics after vaginal delivery in women with ragged placental membranes did not result in a reduction of endometritis. Educating women on the signs and symptoms of endometritis would suffice. Based on the reported incidence of ragged membranes, a change in practice would result in 1500 less prescriptions of antibiotics per annum in these three centres.Trial registrationNCT03459599 (Retrospectively registered on 9 March 2018).

Dataset Information

Wound Infections Following Implant removal below the knee: the effect of antibiotic prophylaxis; the WIFI-trial, a multi-centre randomized controlled trial.

Publications

Wound Infections Following Implant removal below the knee: the effect of antibiotic prophylaxis; the WIFI-trial, a multi-centre randomized controlled trial.

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