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INTRODUCTION: Venous thromboembolism (VTE) is a recognised postsurgical risk. Current prevention methods involve low molecular weight heparin (LMWH), graduated compression stockings (GCS), and intermittent pneumatic compression devices (IPCDs). Australian guidelines, commonly adopted by surgeons, recommend LMWH with GCS and/or IPCDs. IPCDs pose clinical risks, increase care burden, are poorly tolerated, and are costly single-use plastic items. Utilising only LMWH and GCS, without IPCDs, could be more practical, patient-friendly, and cost-effective, with added environmental benefits. METHODS: This is a multicentre, prospective, two-arm randomised controlled non-inferiority trial at five New South Wales (NSW) hospitals, in Australia. We propose to randomise 4130 participants in a 1:1 ratio between arm A: LMWH+GCS+IPCDs (n=2065) or arm B: LMWH+GCS (n=2065). The primary outcome of interest is symptomatic VTE (deep vein thrombosis/pulmonary embolism) identified at the day 30 phone follow-up (FU), confirmed by ultrasound or imaging. Radiologists interpreting the lower-extremity ultrasonography will be blinded to intervention allocation. Secondary outcomes are quality of life at baseline, days 30 and 90 FU using the 5-level European Quality of Life Score, compliance and adverse events with IPCDs, GCS, and LMWH, as well as healthcare costs (from the perspective of the patient and the hospital), and all-cause mortality. The trial has 90% power to detect a 2% non-inferiority margin to detect a reduction rate of VTE from 4% to 2%. ETHICS AND DISSEMINATION: This study has been approved by the Hunter New England Human Research Ethics Committee (2022/ETH02276) protocol V.10, 13 July 2023. Study findings will be presented at local and national conferences and in scientific research journals. TRIAL REGISTRATION NUMBER: ANZCTR12622001527752.
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Tromboembolia Venosa , Trombosis de la Vena , Humanos , Tromboembolia Venosa/tratamiento farmacológico , Heparina de Bajo-Peso-Molecular/uso terapéutico , Aparatos de Compresión Neumática Intermitente/efectos adversos , Calidad de Vida , Estudios Prospectivos , Australia , Trombosis de la Vena/tratamiento farmacológico , Anticoagulantes/uso terapéutico , Ensayos Clínicos Controlados Aleatorios como Asunto , Estudios Multicéntricos como AsuntoRESUMEN
BACKGROUND: The application of antiseptic skin agents prior to incision minimizes the rate of surgical site infection. Despite their ubiquity, the optimal skin preparation agent remains uncertain. A retrospective economic analysis was conducted to complement the results from the NEWSkin Prep trial which prospectively compared three preparation agents. METHODS: A cost and cost-effectiveness analysis was performed from a healthcare service perspective to compare chlorhexidine with 70% ethanol, and aqueous povidone-iodine, against povidone-iodine with 70% ethanol. Resource use estimates accounted for hospital admissions, readmissions associated with surgical site infection, outpatient and general practitioner attendances, visits from community nurses and therapeutic consumables. The measure of effectiveness comprised the net difference in number of patients with surgical site infections per 1000 patients. Costs were compared using a two-sample Welch's t-test. Deterministic and probabilistic sensitivity analyses were performed to evaluate the incremental cost-effectiveness ratio. RESULTS: The null hypothesis that the mean costs for the trial arms were significantly different was not rejected (Welch's t-test P value: 0.771 for chlorhexidine with 70% ethanol against povidone-iodine with 70% ethanol; and 0.955 for aqueous povidone-iodine against povidone-iodine with 70% ethanol). Based on bootstrap averages, the chlorhexidine with 70% ethanol intervention generated 8.0 fewer surgical site infections per 1000 patients and net cost savings of 151,698 (Euros) per 1000 patients compared with povidone-iodine with 70% ethanol, and aqueous povidone-iodine produced a net cost saving of 37,494 per 1000 patients but generated an additional 11.6 surgical site infections per 1000 patients compared with povidone-iodine with 70% ethanol. The comparison of chlorhexidine with 70% ethanol to povidone-iodine with 70% ethanol was sensitive to the inclusion of cost outliers, while the comparison of aqueous povidone-iodine to povidone-iodine with 70% ethanol was sensitive to the estimated cost per surgical site infection. CONCLUSION: Based on the outcomes from the NEWSkin Prep study, this economic analysis found no definitive evidence in favour of any one of the study comparators. Future model-based economic analyses of alternative skin preparations should critically address the quality of evidence and integrate the results from the NEWSkin Prep study.
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Antiinfecciosos Locales , Povidona Yodada , Humanos , Povidona Yodada/uso terapéutico , Infección de la Herida Quirúrgica/epidemiología , Infección de la Herida Quirúrgica/prevención & control , Clorhexidina/uso terapéutico , Análisis de Costo-Efectividad , Estudios Retrospectivos , Antiinfecciosos Locales/uso terapéutico , Etanol , 2-Propanol/uso terapéuticoRESUMEN
Background: There remains debate as to the ideal skin preparation agent to prevent surgical site infection (SSI) after clean implant surgery. This study is a subgroup analysis of all patients undergoing implant surgery in the NEWSkin prep trial. Patients and Methods: The NEWSkin prep trial is a randomized clinical trial (RCT; n = 3300) comparing the three antiseptic skin preparation agents commonly used prior to incisional surgery: chlorhexidine with alcohol (C-Alc), povidone iodine with alcohol (PI-Alc), and aqueous povidone iodine (PI-Aq). All participants who underwent clean incisional surgeries with implants from this trial were selected for analysis. The primary outcome was SSI rate; secondary outcomes were complication rates and re-admission rates. Results: A total of 712 patients in the NEWSkinPrep study underwent clean implant surgery between January 2015 and December 2018. Randomization resulted in the following distribution: C-Alc, 238; PI-Alc, 243; and PI-Aq, 231. Median age of participants was 63 years and 41% were female. Surgical site infection rates were: C-Alc, 10.13%; PI-Alc,11.52%; and PI-Aq, 11.26%. Povidone iodine with alcohol did not appear to be non-inferior to C-Alc (mean difference, 1.39%; 95% confidence interval [CI], -4.17 to 6.95) and PI-Alc was not superior to PI-Aq (mean difference, 0.27%; 95% CI, -5.45 to 5.99; p = 0.9271). There were no differences seen in secondary outcomes between groups. Conclusions: These results indicate a similarity between PI-Alc and C-Alc and that PI-Alc was not superior to PI-Aq. Because this study was not powered to assess these differences in clean cases with implants, additional studies are needed to assess these agents.
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Antiinfecciosos Locales , Humanos , Femenino , Persona de Mediana Edad , Masculino , Antiinfecciosos Locales/uso terapéutico , Povidona Yodada/uso terapéutico , Infección de la Herida Quirúrgica/epidemiología , Infección de la Herida Quirúrgica/prevención & control , Cuidados Preoperatorios/métodos , Clorhexidina/uso terapéutico , EtanolRESUMEN
BACKGROUND: Surgical prophylaxis for venous thrombo-embolic disease (VTE) includes risk assessment, chemical prophylaxis and mechanical prophylaxis (graduated compression stockings [GCS] and/or intermittent pneumatic compression devices [IPCD]). Although there is overwhelming evidence for the need and efficacy of VTE prophylaxis in patients at risk, only about a third of those who are at risk of VTE receive appropriate prophylaxis. OBJECTIVE: There is debate as to the best combination of VTE prophylaxis following abdominal surgery due to lack of evidence. The aim of this survey was to understand this gap between knowledge and practice. METHODS: In 2019 and 2020, a survey was conducted to investigate the current practice of venous thromboembolism (VTE) prophylaxis for major abdominal surgery, with a focus on colorectal resections. The study received ethics approval and involved distributing an 11-item questionnaire to members of two professional surgical societies: the Colorectal Surgical Society of Australia and New Zealand (CSSANZ) and the General Surgeons Australia (GSA). RESULTS: From 214 surgeons: 100% use chemical prophylaxis, 68% do not use a risk assessment tool, 27% do not vary practice according to patient risk factors while > 90% use all three forms of VTE prophylaxis at some stage of treatment. Most surgeons do not vary practice between laparoscopic and open colectomy/major abdominal surgery and only 33% prescribe post-discharge chemical prophylaxis. 42% of surgeons surveyed had equipoise for a clinical trial on the use of IPCDs and the vast majority (> 95%) feel that IPCDs should provide at least a 2% improvement in VTE event rate in order to justify their routine use. CONCLUSION: Most surgeons in Australia and New Zealand do not use risk assessment tools and use all three forms of prophylaxis regardless. Therfore there is a gap between practice and VTE prophylaxis for the use of mechanical prophylaxis options. Further research is required to determine whether dual modality mechanical prophylaxis is incrementally efficacious. Trial Registration- Not Applicable.
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Pautas de la Práctica en Medicina , Cirujanos , Tromboembolia Venosa , Humanos , Cuidados Posteriores , Australia , Nueva Zelanda , Alta del Paciente , Tromboembolia Venosa/prevención & control , Abdomen/cirugíaRESUMEN
INTRODUCTION: The Australian population presenting with surgical pathology is becoming older, frailer and more comorbid. Shared decision-making is rapidly becoming the gold standard of care for patients considering high-risk surgery to ensure that appropriate, value-based healthcare decisions are made. Positive benefits around patient perception of decision-making in the immediacy of the decision are described in the literature. However, short-term and long-term holistic patient-centred outcomes and cost implications for the health service require further examination to better understand the full impact of shared decision-making in this population. METHODS: We propose a novel multidisciplinary shared decision-making model of care in the perioperative period for patients considering high-risk surgery in the fields of general, vascular and head and neck surgery. We assess it in a two arm prospective randomised controlled trial. Patients are randomised to either 'standard' perioperative care, or to a multidisciplinary (surgeon, anaesthetist and end-of-life care nurse practitioner or social worker) shared decision-making consultation. The primary outcome is decisional conflict prior to any surgical procedure occurring. Secondary outcomes include the patient's treatment choice, how decisional conflict changes longitudinally over the subsequent year, patient-centred outcomes including life impact and quality of life metrics, as well as morbidity and mortality. Additionally, we will report on healthcare resource use including subsequent admissions or representations to a healthcare facility up to 1 year. ETHICS AND DISSEMINATION: This study has been approved by the Hunter New England Human Research Ethics Committee (2019/ETH13349). Study findings will be presented at local and national conferences and within scientific research journals. TRIAL REGISTRATION NUMBER: ACTRN12619001543178.
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Calidad de Vida , Cirujanos , Humanos , Anciano , Estudios Prospectivos , Australia , Toma de Decisiones Conjunta , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
BACKGROUND: Surgical Site Infection (SSI) of the abdominal incision is a dreaded complication following colorectal surgery. Identifying the intraoperative surgical site microbes may provide clarity in the pathogenesis of SSIs. Genomic sequencing has revolutionized the ability to identify microbes from clinical samples. Utilization of 16S rRNA amplicon sequencing to characterize the intraoperative surgical site may provide the critical information required to predict and prevent infection in colorectal surgery. METHODS: This is a pilot, prospective observational study of 50 patients undergoing elective colorectal resection. At completion of surgery, prior to skin closure, swabs were taken from the subcutaneous tissue of the abdominal incision to investigate the microbial profile. Dual swabs were taken to compare standard culture technique and 16S rRNA sequencing to establish if a microbial profile was associated with postoperative SSI. RESULTS: 8/50 patients developed an SSI, which was more likely in those undergoing open surgery (5/15 33.3% versus 3/35, 8.6%; P = 0.029). 16S rRNA amplicon sequencing was more sensitive in microbial detection compared to traditional culture. Both culture and 16S rRNA demonstrated contamination of the surgical site, predominantly with anaerobes. Culture was not statistically predictive of infection. 16S rRNA amplicon sequencing was not statistically predictive of infection, however, it demonstrated patients with an SSI had an increased biodiversity (not significant) and a greater relative abundance (not significant) of pathogens such as Bacteroidacaea and Enterobacteriaceae within the intraoperative site. CONCLUSIONS: 16S rRNA amplicon sequencing has demonstrated a potential difference in the intraoperative microbial profile of those that develop an infection. These findings require validation through powered experiments to determine the overall clinical significance.
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Neoplasias Colorrectales , Procedimientos Quirúrgicos del Sistema Digestivo , Humanos , Infección de la Herida Quirúrgica/prevención & control , ARN Ribosómico 16S/genética , Proyectos Piloto , Procedimientos Quirúrgicos del Sistema Digestivo/efectos adversos , Neoplasias Colorrectales/cirugíaRESUMEN
OBJECTIVE: To test the hypothesis that blood donor demographics are associated with transfused polytrauma patients' post-injury multiple organ failure (MOF) status. SUMMARY OF BACKGROUND DATA: Traumatic shock and MOF are preventable causes of death and post-traumatic hemorrhage is a frequent indication for transfusion. The role of blood donor demographics on transfusion recipients is not well known. METHODS: A log-linear analysis accounting for the correlated structure of the data based on our prospective MOF database was utilized. Tests for trend and interaction were computed using a likelihood ratio procedure. RESULTS: A total of 229 critically injured transfused trauma patients were included, with 68% of them being males and a mean age of 45 years. On average 10 units of blood components were transfused per patient. A total of 4379 units of blood components were donated by donors aged 46 years on average, 74% of whom were males. Blood components used were red blood cells (47%), cryoprecipitate (29%), fresh frozen plasma (24%), and platelets (less than 1%). Donor-recipient sex mismatched red blood cells transfusions were more likely to be associated with MOF ( P = 0.0012); fresh frozen plasma and cryoprecipitate recipients were more likely to experience MOF when transfused with a male (vs female) component ( P = 0.0014 and <0.0001, respectively). Donor age was not significantly associated with MOF for all blood components. CONCLUSIONS: Blood components donor sex, but not age, may be an important factor associated with post-injury MOF. Further validation of our findings will help guide future risk mitigation strategies specific to blood donor demographics.
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Donantes de Sangre , Traumatismo Múltiple , Humanos , Masculino , Femenino , Persona de Mediana Edad , Estudios Prospectivos , Insuficiencia Multiorgánica/etiología , Factores de Riesgo , Demografía , Estudios RetrospectivosRESUMEN
INTRODUCTION: Despite advances in achieving low mortality rates with pancreaticoduodenectomy (PD), morbidity remains high. A key contributor to this morbidity is delayed gastric emptying (DGE) occurring with an incidence of up to 30%. The utility of a Braun enteroenterostomy (BE) appears promising to reducing the incidence of DGE, but current research is not definitive. METHODS AND ANALYSIS: This project will be designed as a prospective multicentre randomised controlled blinded study to assess how BE effects the rate of DGE after PD in the setting of malignancy, within Australia-with blinding of patients, outcome assessors and data analysts. Patients will be randomly assigned to PD with Billroth II reconstruction with BE versus PD with Billroth II reconstruction without BE. The primary outcome is the incidence of DGE as defined by the International Study Group of Pancreatic Surgery. Secondary outcomes will include length of hospital stay, postoperative pancreatic fistula incidence, development of major complications (Clavien-Dindo≥3 a), quality of life and 90-day mortality.The study will be powered at 80% to detect a reduction in DGE rate from 30% to 15%, requiring a total of 264 study participants. An interim analysis will be performed once a total of 104 study participants have been recruited at which point the study will be able to detect reduction in DGE from 30% to 10% with 80% power. Statistical analysis will be done with intention-to-treat principles. The proportion of patients suffering DGE will be compared between treatment arms using a χ2 test, with p values used to represent statistical significance. ETHICS AND DISSEMINATION: The study has been ethically approved by the Hunter New England Human Research Ethics Committee (2021/ETH11939), with results disseminated through presentation and publication. TRIAL REGISTRATION NUMBER: CTRN12622000048785.
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Gastroparesia , Pancreaticoduodenectomía , Humanos , Pancreaticoduodenectomía/efectos adversos , Pancreaticoduodenectomía/métodos , Gastroparesia/etiología , Gastroparesia/prevención & control , Gastroparesia/epidemiología , Estudios Prospectivos , Calidad de Vida , Complicaciones Posoperatorias/epidemiología , Resultado del Tratamiento , Vaciamiento Gástrico , Ensayos Clínicos Controlados Aleatorios como Asunto , Estudios Multicéntricos como AsuntoRESUMEN
BACKGROUND: The benefits of mechanical prophylaxis for the prevention of venous thromboembolism (VTE) in abdominal and pelvic surgery are uncertain, with different guidelines stating that graduated compression stockings (GCS) and intermittent pneumatic compression devices (IPCDs) can be used either alone or in combination. To review the efficacy of IPCDs in preventing VTE following abdominal and pelvic surgery. METHODS: A systematic review was conducted, identifying relevant literature reporting clinical trials conducted in abdominopelvic surgery, comparing the effect of IPCDs alone or in combination with no prophylaxis, GCS and chemical prophylaxis. The review identified studies reported from 1966 to 2022 in Medline, Embase, PubMed and Cochrane databases for randomized controlled trials. RESULTS: Thirteen RCTs involving 1914 participants were identified. IPCDs were superior to placebo (OR VTE 0.39; 95% CI 0.20-0.76) but not superior to other forms of prophylaxis (OR 0.83; 95% CI 0.30-2.27) or to GCS alone (OR 0.9; 95% CI 0.24-3.36). The addition of IPCDs to GCS compared with GCS alone was beneficial (OR 0.45; 95% CI 0.23-0.91) as was the addition of IPCDs to standard perioperative chemoprophylaxis (OR 0.25; 95% CI 0.09-0.74). The overall quality and reliability of trials were low, with high risk of bias. CONCLUSIONS: IPCDs are more effective than placebo in reducing VTE rates but are not more effective than other forms of thrombo-prophylaxis (chemical or mechanical) following abdominal and pelvic surgery. There is poor quality evidence to suggest that they might have a role as additional prophylaxis when combined with GCS and chemical prophylaxis.
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Tromboembolia Venosa , Humanos , Tromboembolia Venosa/etiología , Tromboembolia Venosa/prevención & control , Tromboembolia Venosa/tratamiento farmacológico , Reproducibilidad de los Resultados , Abdomen/cirugía , Pelvis/cirugía , Anticoagulantes/uso terapéutico , Medias de Compresión , Aparatos de Compresión Neumática IntermitenteRESUMEN
OBJECTIVE: To compare SSI rates between the skin preparation agents: PI-Aq, povidone-iodine with alcohol (PI-Alc), and chlorhexidine with alcohol (C-Alc). BACKGROUND: Guidelines suggest that alcohol-containing chlorhexidine solutions are the gold standard for skin preparation before surgery. It remains difficult to determine whether it is the chlorhexidine component or the addition of alcohol that confers the most benefit. METHODS: We conducted a multicenter, prospective, combined non-inferiority (PI-Alc vs C-Alc) and superiority (PI-Alc vs PI-Aq) randomized clinical trial. Participants were randomized 1:1:1 to receive either C-Alc, PI-Alc, or PI-Aq. The primary outcome was SSI rate as defined by the Centers for Disease Control. Secondary outcomes were complication rates, length of hospital stay, readmissions, and skin reactions. RESULTS: Between January 2015 and December 2018, 3213 patients were randomized (C-Alc: 1076, PI-Alc: 1075, and PI-Aq: 1062). Mean age of participants was 57% and 55% were female. SSI rates were: C-Alc 11.09%, PI-Alc 10.88%, and PI-Aq 12.56%. PI-Alc was found to be non-inferior to C-Alc (mean difference, -0.21%; 95% confidence interval, -2.85 to 2.44; P = 0.0009 non-inferiority), whereas PI-Alc was not superior to PI-Aq (mean difference, -1.68%; 95% confidence interval, -4.40 to 1.05; P = 0.2302). There were no differences seen in secondary outcomes between groups and no treatment related adverse events or deaths occurred. CONCLUSIONS: PI-Alc is non-inferior to C-Alc and not superior to PI-Aq. This is at odds with current guidelines that suggest alcohol-based chlorhexidine solutions should routinely be used for surgical skin preparation. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Registry: ANZCTRN12615000021571. www.anzctr.org.au.
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Antiinfecciosos Locales , Antiinfecciosos Locales/uso terapéutico , Clorhexidina/uso terapéutico , Etanol , Femenino , Humanos , Masculino , Povidona Yodada/uso terapéutico , Cuidados Preoperatorios , Estudios Prospectivos , Infección de la Herida Quirúrgica/tratamiento farmacológico , Infección de la Herida Quirúrgica/epidemiología , Infección de la Herida Quirúrgica/prevención & controlRESUMEN
BACKGROUND: There is much debate surrounding the ideal antiseptic skin preparation agent to reduce postoperative surgical site infection. International guidelines suggest that chlorhexidine- and alcohol-containing compounds have superior efficacy. However, there are minimal clinical trials specifically looking at skin preparation agents for colorectal surgery. OBJECTIVE: The aim of this study was to compare the efficacy of chlorhexidine in alcohol versus povidone-iodine in alcohol versus povidone-iodine in aqueous solution for the prevention of surgical site infection in colorectal surgery. DESIGN: This is a prospective, 3-armed, randomized controlled trial. SETTING: This study was conducted at the 800-bed John Hunter Hospital and Newcastle Private Hospital, with all subspecialty services in New South Wales, Australia. PATIENTS: All eligible, consenting adults undergoing colorectal surgery between July 2015 and December 2018 were included. INTERVENTIONS: Patients were andomized to receive preincision skin preparation with one of the following: chlorhexidine in 70% alcohol, povidone-iodine in 70% alcohol, or povidone-iodine in aqueous solution. MAIN OUTCOME MEASURE: The primary measure was surgical site infection within 30 days. RESULTS: A total of 482 patients were randomized to chlorhexidine in alcohol, povidone-iodine in alcohol, or aqueous povidone-iodine. The overall surgical site infection rate was 22% (107/482). There was no difference in rates of surgical site infection: 20.6% (29/141), 22.8% (44/193), and 23.0% (34/148), respectively ( p = 0.5267). There was no difference in complication rates: 54.6% (77/141), 46.1% (89/193), and 49.3% (73/148), respectively ( p = 0.1762). The median length of stay was 6 days in all 3 groups. LIMITATIONS: This is a subset analysis of a larger clinical trial for all forms of incisional surgery (the NewSKIN Prep trial), and noninferiority cannot be assessed. Changes in government regulations resulted in a change from 0.5% chlorhexidine in 70% ethanol to 2% chlorhexidine in 70% ethanol during the trial. CONCLUSION: This large, prospective, randomized clinical trial appears to indicate that there is no difference in surgical site infection, complications, or length of stay among the 3 commonest forms of skin preparation in colorectal surgery. See Video Abstract at http://links.lww.com/DCR/B875 .New Zealand Clinical Trials registry: ACTRN12615000021572Agentes antisépticos para la preparación de la piel para prevenir la infección del sitio quirúrgico en la cirugía colorrectal: un ensayo clínico aleatorizado de tres grupos. ANTECEDENTES: Existe un gran debate en torno al agente de preparación de la piel antiséptico ideal para reducir la infección posoperatoria del sitio quirúrgico. Las pautas internacionales sugieren que los compuestos que contienen clorhexidina y alcohol tienen una eficacia. Sin embargo, existen ensayos clínicos mínimos que analizan específicamente los agentes de preparación de la piel para la cirugía colorrectal. OBJETIVO: Comparar la eficacia de la clorhexidina en alcohol versus povidona yodada en alcohol versus povidona yodada en solución acuosa para la prevención de la infección del sitio quirúrgico en cirugía colorrectal. DISEO: Este es un ensayo controlado aleatorio prospectivo de tres brazos. AJUSTE: Este estudio se realizó en el Hospital John Hunter de 800 camas y el Hospital Privado de Newcastle con todos los servicios de subespecialidad en Nueva Gales del Sur, Australia. PACIENTES: Se incluyeron todos los adultos elegibles que dieron su consentimiento para someterse a una cirugía colorrectal entre julio de 2015 y diciembre de 2018. INTERVENCIONES: Aleatorizados para recibir una preparación para la piel previa a la incisión con uno de: clorhexidina en alcohol al 70%, povidona yodada en alcohol al 70% o povidona yodada en solución acuosa. MEDIDA DE RESULTADO PRINCIPAL: La medida principal fue la infección del sitio quirúrgico dentro de los 30 días. RESULTADOS: Un total de 482 pacientes fueron aleatorizados para recibir clorhexidina en alcohol, povidona yodada en alcohol o povidona yodada acuosa. La tasa global de infección del sitio quirúrgico fue del 22% (107/482). No hubo diferencias en las tasas de infección del sitio quirúrgico; 20,6% (29/141), 22,8% (44/193) y 23,0% (34/148) respectivamente; p = 0,5267. No hubo diferencia en las tasas de complicaciones; 54,6% (77/141), 46,1% (89/193) y 49,3% (73/148) respectivamente; p = 0,1762. La duración media de la estancia hospitalaria fue de 6,0 días en los tres grupos. LIMITACIONES: Este es un análisis de subconjunto de un ensayo clínico más grande para todas las formas de cirugía incisional (el ensayo NewSKIN Prep) y no se puede evaluar la no inferioridad. Los cambios en las regulaciones gubernamentales dieron como resultado un cambio de clorhexidina al 0,5% en etanol al 70% a clorhexidina al 2% en etanol al 70% durante la prueba. CONCLUSINES: Este gran ensayo clínico prospectivo y aleatorizado parece indicar que no hay diferencia en la infección del sitio quirúrgico, las complicaciones o la duración de la estancia entre las 3 formas más comunes de preparación de la piel en la cirugía colorrectal. Consulte Video Resumen en http://links.lww.com/DCR/B875 . (Traducción-Dr. Gonzalo Hagerman )Este ensayo se registró de forma prospectiva en el registro de ensayos clínicos de Australia Nueva Zelanda el 15/01/2015: ACTRN12615000021572.
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Antiinfecciosos Locales , Cirugía Colorrectal , Adulto , Antiinfecciosos Locales/uso terapéutico , Clorhexidina/uso terapéutico , Etanol , Humanos , Povidona Yodada/uso terapéutico , Estudios Prospectivos , Estudios Retrospectivos , Infección de la Herida Quirúrgica/epidemiología , Infección de la Herida Quirúrgica/prevención & controlRESUMEN
Deciding whether to delay non-lifesaving orthopaedic trauma surgery to prevent multiple organ failure (MOF) or sepsis is frequently disputed and largely based on expert opinion. We hypothesise that neutrophils and monocytes differentially express activation markers prior to patients developing these complications. Peripheral blood from 20 healthy controls and 162 patients requiring major orthopaedic intervention was collected perioperatively. Neutrophil and monocyte L-selectin, CD64, CD11, CD18, and CXCR1 expression were measured using flow cytometry. The predictive ability for MOF and sepsis was assessed using the Receiver Operating Characteristic (ROC) comparing to C-reactive protein (CRP). Neutrophil and monocyte L-selectin were significantly higher in patients who developed sepsis. Neutrophil L-selectin (AUC 0.692 [95%CI 0.574-0.810]) and monocyte L-selectin (AUC 0.761 [95%CI 0.632-0.891]) were significant predictors of sepsis and were not significantly different to CRP (AUC 0.772 [95%CI 0.650-0.853]). Monocyte L-selectin was predictive of MOF preoperatively and postoperatively (preop AUC 0.790 [95%CI 0.622-0.958]). CD64 and CRP were predictive of MOF at one-day postop (AUC 0.808 [95%CI 0.643-0.974] and AUC 0.809 [95%CI 0.662-0.956], respectively). In the perioperative period, elevated neutrophil and monocyte L-selectin are predictors of postoperative sepsis. Larger validation studies should focus on these biomarkers for deciding the timing of long bone/pelvic fracture fixation.
RESUMEN
BACKGROUND: No study has examined the prevalence of tobacco, other substance use, and symptoms of anxiety and depression, and rates of comorbidities among the orthopaedic trauma population, despite the impact they have on recovery from surgery. This study aims to 1) describe the rates of symptoms and substance use; 2) compare rates of symptoms and substance use among smokers versus non-smokers; and 3) examine the relationship between symptoms and substance use with smoking status. METHODS: A cross-sectional survey of orthopaedic trauma patients was conducted in two Australian public hospitals. Demographic characteristics, smoking status, alcohol consumption, recent cannabis use, and symptoms of anxiety and/or depression were examined. Differences between current and non-smokers were compared using Pearson Chi2 tests. Multivariate logistic regression explored variables related to tobacco smoking. RESULTS: Eight hundred nineteen patients participated. Over one-fifth (21.8%) identified as a current smoker, half (51.8%) reported consuming alcohol at hazardous levels in the last 12 months, and about 10% stated that they had used cannabis in the last 30 days (9.7%), or experienced symptoms of either anxiety (12.4%), or depression (12.9%) in the last two weeks. Over one-fifth of current tobacco smokers (21.8%) reported drinking heavily in the last 12 months and using cannabis recently. Males, with a lower educational attainment, who were unmarried, had used cannabis recently, and report drinking heavily were more likely to be current smokers. CONCLUSIONS: Health behaviour interventions addressing comorbidities are warranted among the orthopaedic trauma population given the high rate of comorbidity and impact these may have on recovery.
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Consumo de Bebidas Alcohólicas/epidemiología , Ansiedad/epidemiología , Depresión/epidemiología , Fumar Marihuana/epidemiología , Procedimientos Ortopédicos , Uso de Tabaco/epidemiología , Adulto , Anciano , Consumo de Bebidas Alcohólicas/psicología , Consumo de Bebidas Alcohólicas/tendencias , Ansiedad/psicología , Comorbilidad , Estudios Transversales , Depresión/psicología , Femenino , Hospitalización/tendencias , Humanos , Masculino , Fumar Marihuana/psicología , Fumar Marihuana/tendencias , Persona de Mediana Edad , Nueva Gales del Sur/epidemiología , Procedimientos Ortopédicos/psicología , Procedimientos Ortopédicos/tendencias , Trastornos Relacionados con Sustancias/epidemiología , Trastornos Relacionados con Sustancias/psicología , Uso de Tabaco/psicología , Uso de Tabaco/tendenciasRESUMEN
BACKGROUND: The potential for the co-existence of genetically disparate cells (microchimerism) and associated cytokine profiles following red blood cell (RBC) transfusion in trauma patients has not been well characterized to date. This study investigated the incidence of surviving donor white blood cells (known as transfused-associated microchimerism (TAM)) and cytokine changes following blood transfusion in trauma patients. STUDY DESIGN AND METHODS: Trauma patients with an injury severity score (ISS) >12 who had been transfused between 2012-2016 with at least 5 units of RBC units over a 4 h period were recruited. Trauma patients with ISS > 12 who did not require blood transfusion were recruited as controls. The incidence of TAM was determined using a panel of insertion/deletion (InDel) bi-allelic polymorphisms. Selected pro- and anti-inflammatory cytokine profiles were analyzed using cytometric bead array. RESULTS: The transfused cohort (n = 40) had median ISS of 28 [12-66], received a median of 11 RBC units [4-114] and had median hospital length of stay of 35 days [1-152]. Only 11 (27.5%) patients returned for follow-up blood sampling after discharge. Of these, one patient showed an InDel pattern indicating the presence of TAM. No patients in the control cohort (n = 49) showed TAM. Cytokines IL-10 and IL-6 were found to be elevated in the transfused trauma patients. CONCLUSION: In this cohort, TAM was found to occur in one patient of the 11 who received a blood transfusion. Elevated IL-6 and IL-10 cytokines were detected in those patients who were transfused. However, the incidence of TAM could not be correlated with the elevated cytokine profiles for this cohort.
Asunto(s)
Donantes de Sangre , Quimerismo , Citocinas/sangre , Transfusión de Eritrocitos/métodos , Leucocitos/metabolismo , Heridas y Lesiones/terapia , Adulto , Australia , Supervivencia Celular , Estudios de Cohortes , Citocinas/metabolismo , Femenino , Humanos , Puntaje de Gravedad del Traumatismo , Leucocitos/citología , Masculino , Persona de Mediana Edad , Heridas y Lesiones/metabolismo , Heridas y Lesiones/patología , Adulto JovenRESUMEN
BACKGROUND: Cell-free mitochondrial DNA (mtDNA) is proinflammatory and has been detected in high concentrations in trauma patients' plasma. Deoxyribonuclease (DNAse) is the free plasma enzyme responsible for the digestion of extracellular DNA. The relationship between mtDNA and DNAse after major trauma is unknown. We hypothesized that DNAse activity would be elevated after injury and trauma surgery and would be associated with high concentrations of extracellular DNA. METHODS: Two-year prospective study was performed on 103 consecutive trauma patients (male, 81%; age, 38 years [interquartile range, 30-59 years]; injury severity score, 18 [interquartile range, 12-26 years]) who underwent standardized major orthopedic trauma surgical interventions. Blood was collected at five perioperative time points (preoperative, postoperative, 7 hours, 24 hours, and 3 days postoperatively). Healthy control subjects (n = 20) were also sampled. Cell-free mtDNA and nuclear DNA (nDNA) were measured using quantitative polymerase chain reaction. Deoxyribonuclease was also assayed in the same plasma samples. RESULTS: Increased levels of mtDNA (from preoperative 163 ± 86 ng/mL to 3 days 282 ± 201 ng/mL, p < 0.0001) and nDNA (from preoperative 28 ± 20 ng/mL to 3 days 37 ± 27 ng/mL, p < 0.05) were present in trauma patients at all perioperative time points compared with healthy controls (mtDNA: 4 ± 2 ng/mL; nDNA: 10 ± 5 ng/mL). Deoxyribonuclease activity was lower in the trauma cohort (from preoperative 0.06 ± 0.04U/mL to 3 days 0.08 ± 0.04U/mL, p < 0.0001) compared with healthy controls (DNAse: 0.17 ± 0.03U/mL). There was no correlation between DNAse and perioperative DNA concentrations. Elevated mtDNA (but not nDNA) correlated with the development of systemic inflammatory response syndrome (SIRS) (p = 0.026) but not multiple organ failure. CONCLUSIONS: The significant perioperative elevation in plasma-free mtDNA concentration is associated with the development of SIRS. The fact that increased cell-free DNA concentrations present with significantly lower than healthy control DNAse activity suggests a potential therapeutic opportunity with DNAse administration to modulate postinjury severe SIRS. LEVEL OF EVIDENCE: Prognostic/Epidemiological, level II.
Asunto(s)
ADN Mitocondrial/sangre , Desoxirribonucleasas/sangre , Síndrome de Respuesta Inflamatoria Sistémica/sangre , Adulto , Estudios de Casos y Controles , Ácidos Nucleicos Libres de Células/sangre , Femenino , Humanos , Puntaje de Gravedad del Traumatismo , Masculino , Persona de Mediana Edad , Insuficiencia Multiorgánica/sangre , Estudios ProspectivosRESUMEN
Background: Smoke-free hospital policies are becoming increasingly common to promote good health and quit attempts among patients who smoke. This study aims to assess: staff perceived enforcement and compliance with smoke-free policy; the current provision of smoking cessation care; and the characteristics of staff most likely to report provision of care to patients. Methods: An online cross-sectional survey of medical, nursing, and allied staff from two Australian public hospitals was conducted. Staff report of: patient and staff compliance with smoke-free policy; perceived policy enforcement; the provision of the 5As for smoking cessation (Ask, Assess, Advise, Assist, and Arrange follow-up); and the provision of stop-smoking medication are described. Logistic regressions were used to determine respondent characteristics related to the provision of the 5As and stop-smoking medication use during hospital admission. Results: A total of 805 respondents participated. Self-reported enforcement of smoke-free policy was low (60.9%), together with compliance for both patients (12.9%) and staff (23.6%). The provision of smoking cessation care was variable, with the delivery of the 5As ranging from 74.7% (ask) to 18.1% (arrange follow-up). Medical staff (odds ratio (OR) = 2.09, CI = 1.13, 3.85, p = 0.018) and full time employees (OR = 2.03, CI = 1.06, 3.89, p = 0.033) were more likely to provide smoking cessation care always/most of the time. Stop-smoking medication provision decreased with increasing age of staff (OR = 0.98, CI = 0.96, 0.99, p = 0.008). Conclusions: Smoke-free policy enforcement and compliance and the provision of smoking cessation care remains low in hospitals. Efforts to improve smoking cessation delivery by clinical staff are warranted.
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Hospitales Públicos , Política para Fumadores , Adulto , Australia , Estudios Transversales , Femenino , Humanos , Masculino , Cuerpo Médico , Persona de Mediana Edad , Oportunidad Relativa , Cooperación del Paciente , Percepción , Autoinforme , Cese del Hábito de Fumar , Encuestas y CuestionariosRESUMEN
Smoking increases the risk of complications associated with orthopaedic trauma surgery, however delivery of care is low. Online interventions may provide needed smoking cessation care and promote abstinence. This study aims to examine the engagement, acceptability, and retention of an online smoking cessation program (Smoke-Free Recovery; SFR) among a sample of orthopaedic trauma patients, as well as themes around the smoking cessation process. A pilot study of SFR with 31 orthopaedic trauma patients admitted to a public hospital in New South Wales, Australia took place. Semi-structured telephone interviews were conducted following hospital discharge. Thematic analysis and descriptive statistics were used. Engagement was high with 28 participants accessing SFR during admission. Twenty individuals completed follow-up phone calls. Program acceptability was rated favourably. After discharge, changes in smoking habits were noted, with program retention low. Themes on program use included: lack of time or need for additional support; computer illiteracy or technology issues; feeling unready or too stressed to quit; or feeling they had reached the boundary of what could be learnt from the program. This study highlights the difficulties faced by patients following hospital admission, the lack of follow-up support received, and the need for consumer testing prior to roll out. Continuing to develop interventions to promote hospital-initiated cessation attempts that continue post-discharge should be a priority.
Asunto(s)
Promoción de la Salud/métodos , Internet , Procedimientos Ortopédicos/rehabilitación , Cese del Hábito de Fumar/métodos , Prevención del Hábito de Fumar/métodos , Telemedicina/métodos , Teléfono , Adulto , Femenino , Conductas Relacionadas con la Salud , Humanos , Masculino , Persona de Mediana Edad , Nueva Gales del Sur , Educación del Paciente como Asunto/métodos , Proyectos Piloto , Factores de TiempoRESUMEN
BACKGROUND: eHealth presents opportunities to provide population groups with accessible health interventions, although knowledge about Internet access, peoples' interest in using the Internet for health, and users' characteristics are required prior to eHealth program development. OBJECTIVE: This study surveyed hospital patients to examine rates of Internet use, interest in using the Internet for health, and respondent characteristics related to Internet use and interest in using the Internet for health. For patients who smoke, preferences for types of smoking cessation programs for use at home and while in hospital were also examined. METHODS: An online cross-sectional survey was used to survey 819 orthopedic trauma patients (response rate: 72.61%, 819/1128) from two public hospitals in New South Wales, Australia. Logistic regressions were used to examine associations between variables. RESULTS: A total of 72.7% (574/790) of respondents had at least weekly Internet access and more than half (56.6%, 357/631) reported interest in using the Internet for health. Odds of at least weekly Internet usage were higher if the individual was born overseas (OR 2.21, 95% CI 1.27-3.82, P=.005), had a tertiary education (OR 3.75, 95% CI 2.41-5.84, P<.001), or was a nonsmoker (OR 3.75, 95% CI 2.41-5.84, P<.001). Interest in using the Internet for health increased with high school (OR 1.85, 95% CI 1.09-3.15, P=.02) or tertiary education (OR 2.48, 95% CI 1.66-3.70, P<.001), and if household incomes were more than AUS $100,000 (OR 2.5, 95% CI 1.25-4.97, P=.009). Older individuals were less interested in using the Internet for health (OR 0.98, 95% CI 0.97-0.99, P<.001). CONCLUSIONS: Online interventions may be a potential tool for health care in this hospitalized population. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12614001147673; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366829&isReview=true (Archived by WebCite at http://www.webcitation.org/6qg26u3En).
RESUMEN
OBJECTIVE: This study investigates orthopaedic trauma patients smoking cessation history, intentions to quit, receipt of smoking cessation care during hospital admission, and patient-related factors associated with receipt of smoking cessation care. METHODS: An online cross-sectional survey of orthopaedic trauma patients was conducted in 2 public hospitals in New South Wales, Australia. Prevalence of smoking and associated variables were described. Logistic regressions were used to examine whether patient characteristics were associated with receipt of smoking cessation care. RESULTS: Eight hundred nineteen patients (response rate 73%) participated. More than 1 in 5 patients (21.8%) were current smokers (n = 175). Of the current smokers, more than half (55.3%) indicated making a quit attempt in the last 12 months and the majority (77.6%) were interested in quitting. More than a third of smokers (37.4%) were not advised to quit; 44.3% did not receive any form of nicotine replacement therapy; and 24.1% reported that they did not receive any of these 3 forms of smoking cessation care during their admission. Provision of care was not related to patient characteristics. CONCLUSIONS: The prevalence of smoking among the sample was high. Respondents were interested in quitting; however, the provision of care during admission was low. Smoking cessation interventions need to be developed to increase the provision of care and to promote quit attempts in this Australian population. LEVEL OF EVIDENCE: Prognostic Level IV. See Instructions for Authors for a complete description of levels of evidence.