ANZCTR search results

Hypothesis That the feasibility, acceptability, cost and effectiveness of early intervention using Vacuum Therapy in the management of burns scars will be supported, in addition to an improvement in scar parameter outcomes in the early intervention cohort when compared to the later intervention cohort.

Opioids are routinely used during surgery however opioids are associated with a range of side effects. As an alternative, opioid-free anaesthesia (OFA) is an emerging mode of anaesthesia intended to avoid these side effects. This study will utilise a randomised clinical trial to investigate the impact of OFA for patients having an elective laparoscopic cholecystectomy or tubal ligation. Patient outcomes to be measured include: • Quality of Recovery (QoR-15); • Oral Morphine Equivalent Daily Dose (OMEDD) at 24 hours post operatively; • Time to first opioid (TTFO) dose; • Post-operative nausea and vomiting (PONV); • Post Anaesthetic Care Unit (PACU) Length of stay (LOS); and • Hospital Length of stay (LOS).

This project aims to examine the relationship between Midwifery Continuity models of care versus other models of antenatal care and breastfeeding continuation beyond hospital discharge, while accounting for potential confounding factors. The hypothesis is that women who were cared for under a Midwifery Continuity of Care model will have higher rates of breastfeeding duration and exclusivity during the postnatal period. The aim of this study is to compare postnatal breastfeeding outcomes at 1 week, 1 month and 4 months postpartum for women who received midwifery led, continuity of care and women who did not receive this model of care. Data will be collected via 5 questionnaires and interviews with pregnant and postpartum women.

The purpose of this study is to determine if a commonly used radiological solution (Gastrografin) is a suitable option to help with the detection of anastomotic leakage, a serious complication of intestinal surgery. Who is it for? You may be eligible for this study if you are an adult who is undergoing rectal resection and extra-peritoneal anastomosis without a diverting loop ileostomy. Study details All participants will undergo their rectal resection as per usual. In the 5 days following the resection, participants will undergo a rectal tube flushing 4 times a day with saline containing Gastrografin. Rectal tube is routinely flushed with saline 4 times per day as part of standard care. A drain fluid sample will be collected twice per day following the flushing of rectal tube with Gastrografin. Two rectal tube specimens will be also be collected, Routine blood tests, that are already performed for usual post operative care, will be recorded. The findings from this study are hoped to provide early evidence of anastomotic leakage and permit clinicians the opportunity to treat patients before they deteriorate. This will lead to better outcomes for patients and a cost saving to health systems.

The study aim is to compare the user seal check and fit test between new and decontaminated N95 respirator. Institutions around the world have explored the options of decontamination and reuse of N95 respirators. Current literature has shown promising results with the use of aerosolised or vapour-phase H2O2 to decontaminate N95 masks. Although multiple studies have been done, there are only a few studies which evaluated fit testing of the decontaminated respirators. Most of these studies tested on a small sample size. We believe quantitative fit testing on a larger group of individuals is essential. This will ensure that tight seal can be maintained on healthcare workers with different facial features after H2O2 decontamination of the N95 masks.

The purpose of this study was to design and trial a group, the Carers Count group, involving the stroke survivor and their carers on a stroke rehabilitation ward which aimed to promote inclusion of carers in rehabilitation and increase therapy dose. Our study aims were to (1) evaluate the implementation of an exercise group for stroke survivors and their carers on a stroke rehabilitation ward and (2) to understand the experiences of stroke survivors and their carers in participating in the group.

This is a multicentre, placebo controlled, randomized, double blind, adaptive study to evaluate the reduction in infection incidence and severity of SARS-CoV-2/ COVID-19 infection among high-risk participants by enhanced trained immune response through VPM1002 vaccine. Participants who fulfil the criteria for high-risk of COVID-19 infection will be enrolled. The Investigator/site staff at each site will inform the healthcare workers (HCWs) about the clinical trial while other high-risk participants will be recruited through referral via COVID-19 clinics or within medical centres/aged care facilities. Follow-up information must be entered by the participants regularly via a study specific mobile App using a phone/tablet/laptop. Participants will receive reminders to enter the data, including temperature reading to indicate the occurrence of fever. During the follow-up, if any participant experiences fever AND cough and/or shortness of breath, all attempts should be made to obtain a throat (nasopharyngeal and/or oropharyngeal) swab or any appropriate sample as directed by the treating physician. Participants can consult/visit the study site anytime during the study for emergencies or any safety concerns. Interim analyses are planned at 2-monthly intervals during the study to assess the efficacy and futility based on which the study will be stopped. An independent Data and Safety Monitoring Board (DSMB) will be appointed to review the safety and primary endpoint data for efficacy/futility. Safety data pertaining to incidences of SARS-CoV-2/COVID-19 infections, hospitalizations, ICU admissions and deaths and interim analysis data will be provided to the DSMB who will provide their observations to the sponsor with recommendations as to whether there are safety concerns and whether the study should continue without change, be modified, or terminated.

The Iron Infusion in Haemodialysis Study – Intravenous iron polymaltose versus no iron in maintenance haemodialysis (MHD): a prospective open-label blinded endpoint randomised controlled trial – will assess the safety and effectiveness of intravenous iron treatment among Indigenous MHD patients with anaemia, high ferritin and low transferrin saturation. All patients 18 years or older on MHD for greater than or equal to 3 months will be eligible for screening and recruitment. We will randomise 576 patients across the Northern Territoy to achieve study power of greater than 80% in detecting a 30% reduction in time to the first of hospitalisation with infection or death. Secondary outcomes will be all serious adverse events, hospital admissions, infection rates, differences in haemoglobin levels over 6 to 12 months, and death. A cost analysis will be performed looking at the costs of treatment, hospital admissions and procedures between the intervention arm versus the control.

Stroke is a leading cause of cardiovascular-related morbidity and mortality in Australia, with approximately one third of strokes being cryptogenic, meaning that they are of undetermined cause. The majority of these are due to embolic stroke of undetermined source (ESUS). Unfortunately, little is known about the underlying causes of ESUS and effective strategies for primary and secondary prevention of recurrent stroke in this population. The purpose of this trial is to determine whether aggressive risk factor modification compared to usual care in patients with embolic stroke can significantly reduce the occurrence of major cardiovascular events. Risk factors including, obesity, hypertension, dyslipidemia, glucose intolerance or diabetes, obstructive sleep apnoea, physical inactivity, alcohol excess and tobacco use will be systematically targeted.

Depression is the single major unmet need in bipolar disorder and current therapies are more efficacious in mania than depression. Key biological factors in the pathophysiology of bipolar disorder may be targeted by the AT1R antagonist, candesartan. Candesartan reduces stress reactivity, impacts the HPA axis, oxidative and inflammatory stress and enhances neurogenesis; all documented pathological markers. The CADET-BD study will test the efficacy of candesartan 16 mg/day as an adjunctive treatment for bipolar depression. CADET-BD is a multi-site, double-blind, randomised, placebo-controlled 16-week trial of candesartan as an add-on to treatment as usual. We plan to recruit 240 participants aged 18 years and above with moderate to severe bipolar depressive disorder.