ANZCTR search results

The ultimate goal of burn wound management is to promote early healing as this has considerable influence on the long term quality and appearance of scarring. Negative pressure wound therapy (NPWT) is a device that is applied to a wound to ultimately help promote healing. It is widely used in both hospitals and the home on a wide range of wounds. A dressing is applied to the wound bed and covered with a transparent film dressing and attached to the therapy device using tubing and a canister. A number of studies have demonstrated improved graft take following split skin graft when NWPT was used compared to standard dressings. However, there is very little information regarding the use of NWPT as a primary treatment for burns with respect to wound progression and pain management. A small number of studies have demonstrated improvement in acute burn wounds with the application of NPWT in the first 48 - 72 hours following injury. In addition, clinically we have seen a reduction in pain with the use of NPWT. The aim of this pilot study is to determine the feasibility of the novel application of NPWT on acute burn wounds. The outcomes of interest being pain, burn wound progression and healing. All children presenting to the Royal Children's Hospital Department of Emergency Medicine with a partial thickness burn injury aged 3 - 15 years of age will be considered for the study. Treating surgical registrars of all children meeting the inclusion/exclusion criteria presenting to the Royal Children’s Hospital, Brisbane will determine eligibility for enrolment in the study. With the parent/caregivers permission an investigator aligned with the study will discuss the study with the parents/caregivers and seek informed consent. Once informed consent is obtained participants will be randomised to one of two treatment groups (standard dressings or standard dressings plus NPWT). Dressings (+/negative pressure depending on group allocation) will be changed at day three post burn injury. Following day three all children will be managed with standard dressings until full re epithelialisation or grafting. Negative pressure will not be reapplied from day three onwards. Outcome measures include burn wound progression measured using laser Doppler imaging on day 0 and day 3, wound healing and pain.

Pneumatic tourniquet has been used in hands and forearm surgery to reduce blood loss. When the tourniquet is used for a longer period under general anaesthesia, rapid heart rate and high blood pressure can be observed. This is often referred to as ‘tourniquet pain’. In awake patients, tourniquet pain is experienced as a vague, dull aching pain in the affected limb associated with an increased blood pressure. Intercostobrachial nerve supplies sensation to the skin of the armpit and inner side of the upper arm. The nerve lies just below the skin and can be easily blocked to help with upper arm tourniquet pain. The purpose of this study is to determine the efficacy of intercostobrachial nerve block which could reduce pain from tourniquet on the upper arm. Patients who suit the participation in the study will be randomised to either group (intercostobrachial nerve block with lignocaine or saline). The pain score will be assessed every 5 minutes after the touniquet is inflated.

The proposed proof of concept study aims to identify factors that influence successful use of the CommunicAid App within a residential aged care setting. Using a case series design the study aims to create five in-depth case profiles of CommunicAid App use, characterising individual client factors (e.g. communication profile, previous use of technology) and environmental factors (e.g. communication opportunities, available communication support, lighting and noise levels within the facility). Systematic analysis and interpretation of the individual case profiles will allow the critical factors to be identified that influence successful use of the App during everyday interactions. This will provide direction for the development of tailored training and communication support strategies to embed use of the App into routine care delivery.

The aim of the study is to assess how reducing adolescent sitting time affects adolescents’ energy levels, cardio-metabolic measures and their level of concentration. To accurately assess these outcomes, the study involves the use of the whole room calorimeter. The whole room calorimeter is a room around the size of an adolescent’s bedroom that measures the oxygen consumption and carbon dioxide production of the person inside. These measurements enable energy levels to be accurately measured. Research shows that adolescents spend more than 50% of their waking hours sitting. The total period of time they sit for per day is only slightly less than the total time the elderly (65 years and older) sit. Research involving adolescent sitting- time and health outcomes is limited. It has been reported that high levels of sitting are associated with lower levels of cardiorespiratory fitness, and higher levels of cholesterol, and body fat. Given the potential harmful effects of excessive sitting and that a large majority of an adolescent’s waking day is spent at school, it is important to understand how much more energy is expended if an adolescent sits for less total time during a typical school day. Currently adolescents spend approximately 240 minutes (4 hours) each day sitting during school time. This study plans to investigate a reduction in sitting time amongst adolescents during a typical day at school. It has the potential to improve the energy expenditure, which can impact health and developmental outcomes of adolescents. This study will provide the highest level of evidence available to move this research field forward, due to use of the University of Wollongong’s whole- room calorimeter, as it is the only one in Australia.

This is a Phase I trial to determine safety and tolerability of paclitaxel in combination with cisplatin and capecitabine in patients with advanced gastric cancer and peritoneal metastases. Who is it for? You may be eligible to join this study if you are aged 18 years or above, have been diagnosed with gastric cancer and peritoneal metastases, and have not had previous chemotherapy for metastatic gastric cancer. Study details All participants will be given the combined treatment of paclitaxel, given through an intraperitoneal catheter (a thin tube surgically inserted through the stomach cavity), cisplatin, given intravenously (through a tube inserted into the vein), and capecitabine, given orally. Different doses will be tested to determine the maximum tolerated dose for paclitaxel. Participants will be follow-up for up to 6 cycles, or 18 weeks, during treatment and then for a further two years post treatment in order to determine safety and tolerability of paclitaxel, response rate, survival and effect of treatment on quality of life.

The research question Does exposing patients to a website containing accurate, free and easily accessible information related to the operation to be performed as part of the consent process improve the informed consent attained? This will be measured by accessing 3 end points: comprehension satisfaction anxiety Hypothesis: The use of the Orthoanswer website, as an adjunct to standard consent procedures, significantly improves the satisfaction and comprehension of informed consent whilst decreasing anxiety levels concerning the operation.

To establish the feasibility, patient acceptability, effect on blood pressure and thereby overall potential of a simplified treatment strategy with 'hypertension polypill', which includes four common blood pressure lowering medications each at 1/4 strength dose. This pilot study will be double blind randomised placebo- controlled crossover trial of 50 patients with established hypertension not on any medical therapy. Subjects will be randomised into two arms - intervention (Quadpill) and control (placebo)- for a period of four weeks. They will undergo office blood pressure as well as 24 hour ambulatory BP assessment at baseline and in 4th week in addition to safety monitoring blood tests. Thereafter there will be a 2 week washout phase prior to crossing over to opposite arm of the study. The patients will undergo another baseline blood and 24 hour ambulatory BP assessment. The study will conclude at 10 week with repeat measurements. The outcomes assessed will be change in the mean blood pressure, safety, tolerability and acceptability.

This study will investigate the impact of chemotherapy on vascular and metabolic parameters that may predispose to cardio-metabolic illness after cancer. Who is it for? You may be eligible to join this study if you are a female aged at least 18 years who has been diagnosed with early stage breast cancer, for which you are due to commence chemotherapy. Healthy age and gender matched control patients will also be recruited to provide a benchmark for comparison. Study details All participants in this study will undergo interviews, questionniares, cardiovascular investigations, and metabolic investigations. This will involve insertion of intravenous cannulas (i.e. into the vein), so that blood samples can be taken. Breast cancer patients will be assessed at 3 timepoints over 9 months, i.e. at baseline (just prior to first chemotherapy) 3 months and then 9 months later. Healthy volunteers will be assessed on a single occasion only. The following assessments will take place at each visit; Study procedures: Participant presents after overnight fast. The visit will take about 5-6 hours. General Assessment: Measuring weight, height, waist and hip circumference, heart rate, blood pressure and temperature will be recorded. Assessment of cardiovascular risk: Measurement of arterial stiffness: assessed by measuring the pressure wave the heart produces in arteries with a small blunt probe. Assessment is not painful and usually takes about 30 minutes to complete. Measurement of autonomic nervous system activity: measured non-invasively: small changes in heart rate and blood pressure will be measured. Urine test: the specimen will then be sent to the lab to be tested for the amount of some chemicals which help measure the activity of the sympathetic nervous system. Measurement of endothelial function: measured by placing a probe on one finger of each hand to record pulsation of the arteries in the finger. By measuring the change in blood vessels after a blood pressure cuff on the arm is inflated and then deflated. Blood tests: A needle will be inserted into a vein in one arm, with a small plastic tube (drip) left in from which we will take blood samples. A baseline blood sample will be taken from you. You will then be asked to eat a meal over 15 minutes; then a series of blood samples will be collected from intravenous catheter over the two hours following the meal. In all, about 75mL of blood (less than one sixth of a blood donation) will be collected as part of this test. The results from these blood tests will tell us how much insulin the body makes in response to the meal. Additional blood samples: When we take the first blood sample before the meal we will also take an additional sample. This could be used to measure the cholesterol and other markers of cardiovascular risk that show up in your blood. Assessment of energy intake and expenditure: Estimating Energy intake: through an interview by on the doctors or nurses involved in the study, and asking to tell us what you have eaten over the last 24 hours. (10 to 15 minutes.) Physical activity: We will ask you to complete a questionnaire to tell us of your physical activity levels over the last 7 days. (10 to 15 minutes) Indirect calorimetry: measures the rate of energy expenditure before and after the meal. A clear plastic hood will be placed over the head for 20 minutes. You can breathe normally while under the hood and it does not restrict the amount of oxygen you inhale. The hood is connected to a machine that measures the energy expenditure Measurement of brown fat activity: by taking a picture with a special infrared camera before and after the meal that measures the temperature in the supraclavicular fossa (lower neck) very accurately. Measurement of body composition using a DEXA machine (the same machine that is used to measure bone density). You will be asked to lie on a bed while a scanner takes a picture of you. The scan is painless and takes about 10 minutes.

This study will investigate the effects of combining metformin with androgen deprivation therapy (ADT) in men with metastatic prostate cancer. You may be eligible to join this study if you are male, aged 18 years or above and have been diagnosed with metastatic prostate adenocarcinoma, for which you have not received any ADT. Study details Participants in this study are randomly allocated (by chance) to one of two groups. Participants in one group will take 3 x 500mg oral tablets of metformin hydrochloride daily for 30 weeks, whilst participants in the other group will take 3 oral tablets of placebo (inactive treatment) daily for 30 weeks. Participants will be followed-up every 6 weeks for 54 weeks, in order to determine metabolic and tumour responses and tumour progression.

Preliminary scientific evidence suggests that Saffron (Crocus sativus) may have beneficial effects on the central nervous system (CNS), and have therapeutic applications for mood, anxiety, depression, insomnia, memory and as an anticonvulsant. The aim of this study is to conduct a preliminary study of a Affron, a standardised extract of Crocus sativus (Saffron) for potential efficacy for mood and cognitive function in healthy adults.