ANZCTR search results

A two-stage tissue expander–to-implant procedure is the most common implant-based reconstructive method, and accounted for 2868 procedures in Australia in 2016. The saline implant with self-sealing port was patented in 1980 by Radovan and requires serial bolus injections of saline to be administered by a clinician every few weeks after surgery. This process can be uncomfortable, lengthy, and logistically challenging for patients and clinics due to the need for ongoing recurrent appointments. The AeroForm® tissue expander (AirXpanders® Inc., Palo Alto, California) is a remote-controlled, carbon dioxide–filled breast tissue expander. It was designed to provide women with a gradual, needle-free, controlled, and faster method of completing the expansion process. This system is composed of an implantable tissue expander containing a reservoir of compressed carbon dioxide, and an external hand-held remote control. The patient uses the controller to activate a valve within the reservoir to release carbon dioxide into the expander, eliminating the necessity for repeated injections and the associated clinic visits. The device is programmed to allow patient dosing in increments of 10 cm3. Multiple safety mechanisms are incorporated into the device design; only one 10cm3 dose of carbon dioxide may be administered during a 3-hour period, and no more than three doses (30 cm3) of carbon dioxide may be given per day. The AeroForm® expander demonstrated successful expansion within 2 weeks with no adverse effects in a sheep model, and the first human trials, conducted in Australia, demonstrated 100 percent success rates in the Patient-Activated Controlled Expansion I and II (pilot and extended pilot) trials. These were single-surgeon trials. These early trials, supported with additional data from the Australian Aspirin to Prevent Recurrent Venous Thromboembolism trial, provided the basis for successful Therapeutic Goods Administration approval of the device in Australia. The only randomised, controlled trial, AeroForm® Patient Activated controlled tissue expander (XPAND) has been performed in the United States, showing statistically significant shorter expansion and reconstruction times compared to saline implant, non-inferiority for safety with a 10 percent margin, and high rates of patient-rated ease, convenience, and satisfaction. The purpose of this study is to undertake the first multi-surgeon case series in Australia. AeroForm® is already standard supply in Gold Coast Health, with very positive patient feedback about the convenience and comfort of patient-controlled inflation. However, it is very important to the surgeons of the unit that clinical outcomes are also satisfactory.

The purpose of this study is to investigate the impact of an Artificial Intelligence (AI) algorithm - Deep Ensemble for Recognition of Malignancy (DERM) - on skin cancer diagnosis services in primary care. Who is it for? You may be eligible for this study if you are over the age of 40 and are visiting your GP with at least one suspicious skin lesion that is suitable for photographing. Study details All participants in this study will have a photograph taken of their suspicious lesion(s) during their regular GP consult, which DERM will analyse. The GP will decide whether to biopsy the lesion before DERM provides a recommendation on whether the lesion should be tested further. Where DERM recommends a lesion is biopsied that the GP otherwise would not have done, the GP may choose to follow DERMs recommendation or their own assessment. It is hoped that this research will help determine if DERM can help identify cancerous skin lesions and reduce the number of unnecessary biopsies.

Endoscopic retrograde cholangiopancreatography (ERCP) is a common intervention in the treatment of biliary and pancreatic diseases, and the demand for ERCP is increasing. There are several difficulties for the anaesthetist to deal with. It is generally performed in a prone or lateral position under moderate to deep sedation or general anaesthesia. The rate of oxygen desaturation could be as high as 11-50%. Both low flow and high flow nasal cannulas are now established ways of delivering oxygen during sedation. It is unclear whether one technique is better than the other. We hypothesis that high flow nasal cannula may provide better oxygen administration and compare these two techniques

In NSW, one in five children are overweight or obese (Hardy et al 2016). Poor diet, inadequate physical activity, excessive screen time and inadequate sleep are the key behavioural risk factors for unhealthy weight gain in childhood (Bauman et al 2016). As key role models and decision makers and decision makers regarding their child’s food intake, physical activity, screen time and sleep patterns, parents have a critical role to play in childhood obesity prevention. Despite the important role parents have, there are recognised barriers to parental participation in child obesity prevention or weight management programs such as scheduling of sessions (Young et al 2007), finding childcare for other siblings (Kelleher et al 2017), travel (Warren et al 2007). Also, existing services that provide information for parents with young children are often not evidence based, and lack a population-wide infrastructure, thereby making it difficult for some parents to access and benefit from them. Online and telephone-based obesity prevention programs offer advantages in convenience and accessibility compared with conventional face-to-face programs currently available in NSW and have the potential to be delivered population wide at relatively low cost (Eakin et al 2010). This study aims to evaluate the effectiveness and cost-effectiveness of two health promotion programs (‘Healthy Habits’ – telephone based program and ‘Time2bHealthy – online program) designed to support parents of 2-6 year old children to promote healthy eating, physical activity and adequate sleep in children. It also aims to determine the most optimal approaches to maximising recruitment to and retention of parents in such programs. The study will employ a three-arm parallel-group randomised preference trial design. Participants may choose to participate in a telephone-based program (Healthy Habits), an online program (Time2bHealthy) or receive written educational materials which will serve as the comparison group. Participants who do not have a particular preference will be randomly allocated to one of the three arms. It is expected that this research will identify one or more programs for parents of children aged 2-6 years that are effective in improving their child’s behaviours (nutrition, physical activity, sedentary time and sleep). The programs will be implemented in New South Wales, Australia and contribute to the Premier’s Priority target of reducing childhood overweight and obesity.

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple subcutaneous (SC) doses of CBP-201 in patients with moderate to severe Atopic Dermatitis. Thirty patients will be randomized at approximately 10 study sites. This research study is made up of the following parts: Screening Period, Baseline, Treatment Period and Follow-Up Period. Patients will be randomized to receive either CBP-201 or placebo once a week for 4 doses. Each dose group will consist of 10 participants, with 8 participants receiving active study drug and 2 receiving matching placebo (8 active: 2 placebo). Three ascending dose levels are planned (75, 150 and 300 mg CBP-201). Patients will be followed for an additional 8 weeks for safety, efficacy and to further characterize the profile of CBP-201.

Brief Summary Cranial reconstruction using mesenchymal stromal cells and resorbable biomaterials, will result in the patient producing their own bone to fill the void which will reduce the risk of infection and resorption, lead to a better cosmetic result and obviate any long term consequence of having a synthetic material in vivo. Introduction: There are several reasons that parts of the skull may need to be removed: - After trauma to relieve brain swelling - During brain surgery (for brain cancer) - After trauma where the bone is so badly fractured/fragmented it needs to be removed. In all but the last case the bone flap is temporarily stored in a freezer and once the brain swelling has subsided it is reinserted. This procedure is called "autologous cranioplasty"; autologous, because it originally came from the patient and cranioplasty, referring to the repair. Although this is a straightforward procedure, there are a number of complications including infection and bone resorption that can occur. This study: Stromal cells have a proven ability to aid in bony healing. Furthermore stromal cells on a ceramic framework encased in a plastic scaffold have been shown in a small clinical trial to lead to healing of skull defects. In the present study, it is proposed to add stromal cells, either autologous or allogeneic, to a resorbable ceramic material and insert into the skull. The ceramic is designed to dissolve away over time as the body's own blood vessels and cells populate the construct and create the patient's new bone. It has been proven that without the encouragement of the cells and temporary scaffold materials, a hole in the skull will not heal. Given the incidence of bone resorption/infection and metal plate infection using traditional methods, it would seem prudent to provide a construct that will allow controlled replacement with the patient's own bone, thus negating any adverse long-term complications with synthetic materials that remain for life.

This study aims to evaluate the feasibility and safety of normal saline, compared to heparinised saline, for the prevention of occlusions (blockages) in central venous access devices (CVADs) in a paediatric oncology population. Who is it for? You or your child may be eligible to join this study if you/they are aged 0-18 years, have been diagnosed with an oncological or malignant haematological condition, and have a central venous access device (CVAD) in situ. CVADs are flexible tubes inserted in the chest, neck or upper arm veins, which enable the administration of anti-cancer drugs, collection of blood tests, and delivery of supportive therapies. Study details Participants in this study will be randomly allocated (by chance) into one of two groups. Participants in one group will have their CVAD locked with 0.9% Sodium Chloride, whilst participants in the other group will have theirs locked with heparinised saline. Duration of study enrollment will be capped at six weeks. All participants will be monitored throughout their enrolment in the study to determine any CVAD blockages (known as occlusions), or other adverse events such as venous thrombosis and infection. We hope to determine whether a larger efficacy trial of these CVAD locking techniques is feasible and safe.

The aim of this study is to evaluate the effectiveness of different types of information leaflets on intention to undergo imaging for non-serious low back pain in patients with low back pain and the general public.

The ability of artificial tear supplements, that are commercially available ‘over-the-counter’, to improve tear film stability and reduce symptoms of dry eye will be evaluated. Specifically the clinical course of artificial tear supplement effects, including how quickly improvements in signs and symptoms occur and the time taken to reach maximal treatment effect will be assessed. The outcomes relative to dry eye subtype, such as those deficient in tear volume or those who exhibit poor tear quality at baseline, will be evaluated.

Obesity is one of the greatest health challenges facing today’s adolescents, who are now the largest global population segment (>25%). In Australia, over 30% of adolescents (13-18 years) are overweight or obese. Weight gain during adolescence is related to heart disease in later life. Implementing accessible obesity interventions could save our society $2.1B over the next 10 years. Hence, it is important we develop contemporary, low-cost, and engaging population-based obesity prevention solutions. Presently, Australian adolescents have limited access to age-appropriate obesity prevention services. There is a growing body of evidence indicating text messaging interventions are effective for secondary prevention of heart disease and our team has a successful program of related research. However, there is limited evidence for the role of text messages to engage adolescent populations in obesity prevention behaviours. In our preliminary work, through expert workshops and consumer testing, we have developed a bank of 300 evidence-based text messages that are acceptable and engaging for adolescents. In this randomised controlled trial, we aim to test the effectiveness of this healthy lifestyle text message program (TEXTBITES), with optional health counselling, compared to usual care in improving body mass index and lifestyle outcomes in overweight adolescents. Participants will be randomly assigned to the intervention program or standard care for 6-months. BMI and lifestyle outcomes will be assessed at the completion of the program, 6-months and all participants will be followed up 6-months later (12-months from baseline). There are no foreseen physical or psychological risks associated with participation in this study. For safety purposes, an independent, unblinded researcher will monitor all incoming text messages. This potentially scalable project will inform future practice and community initiatives to promote obesity prevention behaviours for adolescents.