Antibiotic prophylaxis in breast cancer surgery. A randomized controlled trial.
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ABSTRACT:
SUBMITTER: Prudencio RMA
PROVIDER: S-EPMC7531055 | biostudies-literature | 2020
REPOSITORIES: biostudies-literature
Publications
Antibiotic prophylaxis in breast cancer surgery. A randomized controlled trial.
Prudencio Rubens Murilo de Athayde RMA Campos Fabíola Soares Moreira FSM Loyola Ana Beatriz Alkmim Teixeira ABAT Archangelo Junior Ivanildo I Novo Neil Ferreira NF Ferreira Lydia Masako LM Veiga Daniela Francescato DF
Acta cirurgica brasileira 20200930 9
<h4>Purpose</h4>To assess the effect of antibiotic prophylaxis on surgical site infection (SSI) rates in women undergoing breast cancer surgery in two tertiary hospitals in Brazil.<h4>Methods</h4>This was a randomized, double-blind, placebo-controlled, parallel-group clinical trial. A total of 124 women without independent risk factors for SSI were randomly assigned to receive either cefazolin (antibiotic group, n = 62) or placebo (control group, n = 62) as preoperative prophylaxis. After surger ...[more]
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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.
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Project description:BackgroundParticipants were patients with invasive breast cancer undergoing primary surgery. The aim was to test whether a single dose of amoxicillin-clavulanic acid would reduce wound infection at 30 days postoperatively, and to identify risk factors for infection.MethodsParticipants were randomised to either a single bolus of 1.2 g intravenous amoxicillin-clavulanic acid after the induction of anaesthesia (intervention) or no antibiotic (control). The primary outcome was the incidence of wound infection at 30 days postoperatively.ResultsThere were 871 evaluable patients. Of these, 438 received prophylactic antibiotic and 433 served as controls. Seventy-one (16.2 per cent) patients in the intervention group developed a wound infection by 30 days, while there were 83 (19.2 per cent) infections in the control group. This was not statistically significant (odds ratio (OR) 0.82, 95 per cent c.i. 0.58 to 1.15; P = 0.250). The risk of infection increased for every 5 kg/m2 of BMI (OR 1.29, 95 per cent c.i. 1.10 to 1.52; P = 0.003). Patients who were preoperative carriers of Staphylococcus aureus had an increased risk of postoperative wound infection; however, there was no benefit of preoperative antibiotics for patients with either a high BMI or who were carriers of S. aureus.ConclusionThere was no statistically significant or clinically meaningful reduction in wound infection at 30 days following breast cancer surgery in patients who received a single dose of amoxicillin-clavulanic acid preoperatively.Registration numberN0399145605 (National Research Register).
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Project description:BackgroundThe growing resistance of bacteria to antimicrobial medicines is a global issue and a direct threat to human health. Despite this, antibiotic prophylaxis is often still routinely used in dental implant surgery to prevent bacterial infection and early implant failure, despite unclear benefits. There is a lack of sufficient evidence to formulate clear clinical guidelines and therefore there is a need for well-designed, large-scale randomized controlled trials to determine the effect of antibiotic prophylaxis.PurposeTo compare the effect of a presurgical antibiotic regimen with an identical placebo regimen in healthy or relatively healthy patients receiving dental implants.Materials and methodsThe 474 patients participating in the study were recruited from seven clinics in southern Sweden. We randomized the patients into a test and a placebo group; the study was conducted double-blinded. Preoperatively, the test group received 2 g of amoxicillin and the control group, identical placebo tablets. The primary outcome was implant failure; secondary outcomes were postoperative infections and adverse events. Patients were evaluated at two follow-ups: at 7-14 days and at 3-6 months.ResultsPostoperative evaluations of the antibiotic (n = 238) and the placebo (n = 235) groups noted implant failures (antibiotic group: six patients, 2.5% and placebo group: seven patients, 3.0%) and postoperative infections (antibiotic group: two patients, 0.8% and placebo group: five patients, 2.1%). No patient reported any adverse events. Between-group differences in implant failures and postoperative infections were nonsignificant.ConclusionAntibiotic prophylaxis in conjunction with implant placement is likely of small benefit and should thus be avoided in most cases, especially given the unabated growth in antibiotic-resistant bacteria.Clinical trial registration numberNCT03412305.
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Project description:PurposeThe usefulness of topical antibiotic prophylaxis for routine oculofacial plastic surgery is not well established. Given concerns such as contact dermatitis, antibiotic resistance, and healthcare costs in conjunction with a low baseline rate of surgical site infections, the investigators sought to determine the frequency of infection with and without the use of topical antibiotic prophylaxis.DesignRandomized, controlled, unmasked clinical trial.ParticipantsAdult patients undergoing routine periocular surgery without prior history of periocular surgical site infection, need for perioperative oral or parenteral antibiotics, or allergy to all study medications.MethodsParticipants were randomized before surgery to receive either antibiotic or placebo (mineral oil and petrolatum-based) ointment after surgery. Outcomes were measured at the first postoperative visit. The 2-tailed Fisher exact test was used to compare outcomes between groups.Main outcome measuresThe primary outcome was the incidence of surgical site infections. The secondary outcomes included stratification of infections by patient risk characteristics, incidence of allergic contact dermatitis, and incidence of wound complications.ResultsFour hundred one participants were enrolled and randomized, and 13 participants did not proceed with surgery or were lost to follow-up. High-risk features for infection were identified in 24% of the placebo group and 21% of the antibiotic group. Surgical site infections were more common in the placebo group (2.7% vs. 0.0%; P = 0.025). The rate of contact dermatitis was similar (0.5% vs. 0.5%; P = 1.00), as was the rate of wound dehiscence (2.7% vs. 3.5%; P = 0.77). Among the placebo group, the incidence of infections in the low- and high-risk participants was 2.9% and 2.2%, respectively. Infections were treated with oral or topical antibiotics and resolved without complication, except in 1 patient who required 2 subsequent surgeries to address the sequelae.ConclusionsAfter routine oculofacial plastic surgery, patients treated with a topical antibiotic ointment showed a lower risk of surgical site infection compared with patients treated with a nonantibiotic ointment.
| S-EPMC7686086 | biostudies-literature
Project description:The role of antibiotics in surgical procedures where the risk of surgical site infection (SSI) is low remains uncertain. There is, to date, no evidence to justify the routine use of antibiotics in postoperative reduction mammaplasty. The aim of this study is to evaluate the effect of postoperative antibiotic treatment on the occurrence of SSI after breast reduction surgery.This is a double-blind randomized clinical trial with 124 breast hypertrophy patients allocated to two treatment groups: antibiotic (n?=?62) and placebo (n?=?62). All patients will undergo reduction mammoplasty, performed by the same surgical team. The surgeons will raise the nipple-areola complex by the superomedial pedicle technique. The patients will receive antibiotics intravenously during anesthetic induction and every 6 hours thereafter during their 24-hour hospital stay. During discharge from the hospital, each patient will receive a numbered package containing either cephalexin or placebo capsules and will be directed to take one capsule every 6 hours for 7 days. Neither the surgery team nor the patients will know the contents of the capsules. Patients will be monitored for the occurrence of SSI once weekly during the first 30 days following hospital discharge by a single surgeon who is blinded to their treatment group. SSI will be evaluated based on the definition adopted by the Centers for Disease Control and Prevention.Due to the variety of risk factors for SSI and limited case studies, conclusions regarding the effect of antibiotics on the occurrence of SSIs following reduction mammaplasty are potentially biased. In recent studies, perioperative antibiotic prophylaxis was effective in preventing infection and is therefore recommended in clinical practice. However, antibiotic use in the postoperative period still remains controversial.Clinicaltrials.gov Identifier: NCT02569866 . Registered on 4 October 2015.
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Project description:BACKGROUND:Colorectal surgery is frequently complicated by surgical site infections (SSIs). The most important consequences of SSIs are prolonged hospitalization, an increased risk of surgical reintervention and an increase in mortality. Perioperative intravenously administered antibiotic prophylaxis is the standard of care to reduce the risk of SSIs. In the last few decades, preoperative orally administered antibiotics have been suggested as additional prophylaxis to further reduce the risk of infection, but are currently not part of routine practice in most hospitals. The objective of this study is to evaluate the efficacy of a preoperative orally administered antibiotic prophylaxis (Pre-OP) in addition to intravenously administered perioperative antibiotic prophylaxis to reduce the incidence of deep SSIs and/or mortality after elective colorectal surgery. METHODS/DESIGN:The PreCaution trial is designed as a multicenter, double-blind, randomized, placebo-controlled clinical trial that will be carried out in The Netherlands. Adult patients who are scheduled for elective colorectal surgery are eligible to participate. In total, 966 patients will be randomized to receive the study medication. This will either be Pre-OP, a solution that consists of tobramycin and colistin sulphate, or a placebo solution. The study medication will be administered four times daily during the 3 days prior to surgery. Perioperative intravenously administered antibiotic prophylaxis will be administered to all patients in accordance with national infection control guidelines. The primary endpoint of the study is the cumulative incidence of deep SSIs and/or mortality within 30 days after surgery. Secondary endpoints include both infectious and non-infectious complications of colorectal surgery, and will be evaluated 30 days and/or 6 months after surgery. DISCUSSION:To date, conclusive evidence on the added value of preoperative orally administered antibiotic prophylaxis in colorectal surgery is lacking. The PreCaution trial should determine the effects of orally administered antibiotics in preventing infectious complications in elective colorectal surgery. TRIAL REGISTRATION:Netherlands Trial Register, ID: NTR6113 . Registered on 11 October 2016; EudraCT 2015-005736-17.
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Project description:Radiation-induced toxicity is a major limiting factor for prescribing radiation dose in cancer radiotherapy. Skin reaction to radiation is one of the primary concerns, which could affect quality of life of the patients both physically and mentally. Reviews of the literature show limited number of effective reagents for its prophylaxis. In this study, we attempted to determine whether prophylactic treatment of the 3 different herbal creams containing Centella asiatica, Cucumis sativus, and Thunbergia laurifolia extracts as well as a commercial moisturizing cream could reduce acute skin reaction in breast cancer patients undergoing radiotherapy. A total of 153 breast cancer patients undergoing radiotherapy were randomly assigned into 5 different groups with one group receiving no treatment. The patients were instructed to apply their designated creams once daily from their first radiotherapy session until 1-month post-irradiation. Their skins were graded by a radiation oncologist on a weekly basis until 1-month post-irradiation to identify any skin reactions. The results showed that the administration of the herbal creams or the moisturizing cream could neither reduce the severity nor delay the onset of dermatitis compared with the no treatment group. However, despite the limited benefits from the prophylaxis, the Cucumis sativus cream was shown to help with the skin recovery post-irradiation. These results suggested that breast cancer patients undergoing radiotherapy should be advised to apply moisturizing cream to the area of irradiated skin.
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Project description:BackgroundThe indication for antibiotic prophylaxis in burn patients remains highly controversial, with no consensus having been reached. The objective of antibiotic prophylaxis is to reduce the risk of postoperative local and systemic infections. Burn surgery is associated with a high incidence of bacteremia, postoperative infections, and sepsis. However, antibiotic prophylaxis exposes patients to the risk of selecting drug-resistant pathogens as well as to the adverse effects of antibiotics (i.e., Clostridium difficile colitis). The lack of data precludes any strong international recommendations regarding perioperative prophylaxis using systemic antibiotics in this setting. The goal of this project is therefore to determine whether perioperative systemic antibiotic prophylaxis can reduce the incidence of postoperative infections in burn patients.MethodsThe A2B trial is a multicenter (10 centers), prospective, randomized, double-blinded, placebo-controlled study. The trial will involve the recruitment of 506 adult burn patients with a total body surface area (TBSA) burn of between 5 and 40% and requiring at least one excision-graft surgery for deep burn injury. Participants will be randomized to receive antibiotic prophylaxis (antibiotic prophylaxis group) or a placebo (control group) 30 min before the incision of the first two surgeries. The primary outcome will be the occurrence of postoperative infections defined as postoperative sepsis and/or surgical site infection and/or graft lysis requiring a new graft within 7 days after surgery. Secondary outcomes will include mortality at day 90 postrandomization, skin graft lysis requiring a new graft procedure, postoperative bacteremia (within 48 h of surgery), postoperative sepsis, postoperative surgical site infection, number of hospitalizations until complete healing (> 95% TBSA), number of hospitalization days living without antibiotic therapy at day 28 and day 90, and multiresistant bacterial colonization or infection at day 28 and day 90.DiscussionThe trial aims to provide evidence on the efficacy and safety of antibiotic prophylaxis for excision-graft surgery in burn patients.Trial registrationClinicalTrials.gov NCT04292054 . Registered on 2 March 2020.
| S-EPMC7687822 | biostudies-literature
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.
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