ANZCTR search results

The aim of this project is to assess a new kind of dressing, to see whether it reduces the rate of wound infections after abdominal surgery. The dressing is attached to a small, portable device that creates suction or negative pressure on the wound, to help suck away any fluid that leaks from the wound. These dressings have been assessed as being safe, and are already in use in the hospital. However, there is no conclusive evidence that they provide a benefit to patients by reducing wound infections. We will hopefully answer that question, and help to provide better outcomes to future patients undergoing abdominal surgery. This study is in part funded by the company that makes the dressing used. However, they do not provide any direct payment to the investigators, and do not have any role in collecting information or deciding what the results of the study are. This research is being conducted by doctors and nurses working in Dandenong Hospital, under the auspices of the Monash School of Medicine.

When we breathe, we take in oxygen and get rid of carbon dioxide. Based on previous studies, many done at the Royal Women’s Hospital, we believe that monitoring carbon dioxide that the baby breathes out may be a useful tool to improve our ability to help babies breathe at birth. The purpose of this study is to measure and define the common values of carbon dioxide that a healthy baby breathes out during the first ten minutes of life. Carbon dioxide will be measured whilst the newborn baby breathes into a mask, intermittently, during the first ten minutes of life, with repeated measurements at 1-2 hours and 12-72 hours of life. With the knowledge gained about how much carbon dioxide is breathed out in the first minutes after birth, more effective ways of helping babies breathe at birth can be developed.

Contact lens discomfort is a multifactorial condition that is “characterised by episodic or persistent adverse ocular sensations related to contact lens wear, which can lead to decreased wearing time and discontinuation.” Currently, the main form of treatment for contact lens discomfort is the use of artificial tears (lubrication drops), which can assist in reducing these symptoms by supplementing the deficient tear fluid. However, as artificial tears fail to address the underlying cause of the condition, for many patients they are inadequate in completely relieving symptoms. New and enhanced therapeutic treatments are therefore needed. Inflammation has been implicated in the pathogenesis of contact lens discomfort. The aim of this ‘proof-of-concept’, single site clinical trial is to evaluate the benefit of different formulations of omega-3 supplements for treating contact lens discomfort.

Now that newborn hearing checks are available, hearing loss is often picked up soon after birth and hearing aids are fitted shortly after. There are standard procedures for checking that the hearing aids make sounds audible to a child, but no one knows how effective the hearing aids are for supporting discrimination between sounds because there are no clinical tools to do so. Further, no one knows whether this early discrimination ability may relate to later language development of children with hearing loss. The IDEAL study aims to 1) develop new clinical tools for assessing whether an infant with hearing loss can hear the differences between sounds after they are fitted with hearing aids; and 2) determine the relationship between early auditory discrimination and spoken language skills at 3 years of age for children with hearing loss. The findings will provide the much-needed evidence to guide best-practice management of children with hearing loss.

This randomized controlled trial compared the efficacy of a brief parenting intervention with a standard parenting intervention and a waitlist control group, for reducing toddler aggressive behaviour, dysfunctional parenting and related aspects of family functioning. It was hypothesized that both interventions would show superior improvements relative to the control group in child aggressive behaviours and other child and family outcomes, but that the brief and standard interventions would not differ significantly from one another at post-assessment or 6-month follow-up.

This study will determine whether administering a healthy lifestyle intervention targeting multiple cancer risk factors, namely smoking, poor diet and physical inactivity, will change behaviours among people attending residential substance abuse treatment. The study will be conducted with people who are attending The Salvation Army Recovery Service Centres located in New South Wales and the Australian Capital Territory, Australia. You may be eligible to join this study if you are aged 18 years or above, have an alcohol or other substance abuse dependence disorder and are attending The Salvation Army Recovery Service Centre. Study details: Cardiovascular disease and cancer are leading causes of mortality for people with a history of substance abuse problems and it requires prevention strategies that address primary risk factors such as smoking, poor diet, and physical inactivity. The current project will trial the Healthy Recovery Program, a group based intervention that targets multiple cancer risk factors. Each service centre will be randomly allocated (by chance) to one of two programs: a Healthy Recovery program or the usual residential substance abuse treatment program provided by the Salvation Army. The Healthy Recovery program focuses on helping participants to reduce their smoking, improve their diet and increase their level of physical activity in a group setting. The intervention involves a combination of health focused psycho-education, goal setting, monitoring, motivational interviewing, and cognitive behavioural therapy. Participants will be asked to complete a number of questionnaires at 8-weeks, 3-months and 6 months post-intervention to assess frequency of smoking, fruit and vegetable consumption, physical activity, alcohol and substance use, quality of life and mental health. Results from this study will inform the development and implementation of multiple health behaviour change interventions for other marginalised populations.

The meal study is to assess the acute effects of red meat and dairy on glucose metabolism. This follows a longer term dietary trial that investigated the effect on insulin sensitivity after following three 4-week long diets: one high in lean red meat diet with minimal dairy; one high in dairy with no red meat; and a diet that had no red meat and minimal dairy. Evidence is conflicting about the benefits or risks of consuming meat and dairy products on insulin sensitivity and there is little understanding of the mechanisms behind the findings observed in epidemiological studies.

This study is an imaging study which aims to evaluate whether the use of magnetic resonance imaging (MRI) guided audiovisual biofeedback system can improve the precision of lung cancer radiotherapy. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with stage I-III lung cancer for which you will be treated with radical radiotherapy with or without chemotherapy. Study details All participants will attend 3 additional sessions to standard care. The first session is a breathing training session with audiovisual feedback. This will involve a visual display of a respiratory waveguide. Participants will be asked to regulate their breathing to keep a red ball within the blue wave guide. The aim is for the ball to stay within the line by adjusting breathing by the participant. The second and third sessions participants will undergo MRI scans with and without audiovisual feedback. These MRI sessions will occur pre-radiotherapy treatment and mid-treatment (3 to 6 weeks later). All imaging protocols used are approved clinical procedures. The acquired images will be used to evaluate the reproducibility of respiratory-related tumour motion and whether this leads to improved treatment precision i.e. a reduction in radiotherapy dose delivered to healthy tissues.

The prone position is a body position in which a person lies horizontal with the chest down and back up. With appropriate pillows and positioning, it is a safe position for pregnant women and because of this the position is utilised in the allied health fields and for relaxation and massage in pregnant women. In this position uterine compression of the large maternal vessels is alleviated. Yet, despite this, the prone position is rarely used in the medical setting in pregnant women and there is very little information about the position in the medical literature. There is no published information about the prone position in women with hypertension in pregnancy including preeclampsia. We have recently published a new unified theory of preeclampsia. It proposes that the development of hypertension in pregnant women is an adaptive response to the demands of a growing fetus and is driven by an imbalance between maternal oxygen supply to the fetus (which may be caused by inadequate blood flow to the uteroplacental unit) and fetal oxygen demands. When thinking about the prone position in the light of this new theory we hypothesise that placing a pregnant women, with new onset pregnancy associated hypertension, into this position may reduce her blood pressure by eliminating abdominal compression of blood vessels thereby reducing abdominal vascular resistance and improving blood flow. This proposed study aims to test this hypothesis.

The administration of intravenous fluid is a common intervention in acutely unwell patients. Although normal saline has been the dominant crystalloid fluid worldwide for more than century, at present, intensive care specialists in Australia and New Zealand (ANZ) broadly regard all intravenous crystalloid solutions, including normal saline and plasmalyte as equivalent. They will administer one of these two fluids for resuscitation or rehydration according to personal preference or clinical judgment in the absence of evidence that one is superior to the other in terms of clinical outcomes. Before definitive multicenter double-blind randomized controlled trials can be performed, pilot studies are necessary to guide their optimal execution. Such pilot work makes it possible to assess the following crucial aspects of trial execution: feasibility of study design, degree of biochemical and physiological separation achieved with study interventions, safety of study approach, likely recruitment rate, likely effects, likely amounts of fluids used per patient, and power calculations. Accordingly, we propose to perform a pilot multicenter randomized double-blind controlled trial to compare the feasibility, safety, biochemical and physiological effects of treating patients requiring fluid resuscitation with either normal saline or plasmalyte. On the basis of previous comparative data, we plan to study 60 patients (30 treated with saline vs. 30 treated with plasmalyte) and to use base excess during the first 4 days (when most of fluid administration takes place) in ICU as the primary outcome measure.