ANZCTR search results

The RECELL® autologous cell harvesting device enables rapid autologous epidermal replacement. The paucity of data substantiating its implementation in acute paediatric burn injuries warrants further evaluation. This study aims to compare effectiveness of three commercially available burn wound management approaches used for burn injuries. Informed consent of parent/guardians of children meeting the inclusion criteria will be obtained the demographic data collected. Participants will be randomised to standard silver dressing or Biobrane® with RECELL® or Biobrane® only. These will be initially applied under a general anaesthetic in the operation theatre. Data acquisition will be from digital imaging, sonography, colorimetry and assessments of pain, itch, dressing application ease, treatment satisfaction, intervention fidelity, health- related quality of life, scar assessment and health resource utilisation will be recorded. Intervals for data collection will be at baseline, at all 3-5 day dressing changes until wound is 95% or more re-epithelialised and at outpatient follow up at 3, 6 and 12 months post injury.

Hypothesis It is estimated that >30% of early breast cancer patients who have received systemic adjuvant treatment will experience survivorship issues in the subsequent 5 years following diagnosis. During this period, it may affect physical and psychosocial functioning, with changes to their employment and/or financial status, and the severity and incidence will diminish over time. Aim The aim is to identify how a prior diagnosis of breast cancer and its treatment impacts on physical and psychosocial functioning over time. For this trial, no study specific visit at the clinic is required. Who is it for? In this trial, any participant aged 18 years and above who has been diagnosed with early breast cancer, undergone breast surgery and completed their adjuvant treatment under the care of clinicians at Breast Cancer Research Centre-WA will be asked to complete a questionnaire of 192 questions. It will assess the prevalence and magnitude of physical and psychosocial issues in breast cancer survivors. In addition, some demographic information will be collected. Study details Upon return of signed Participant PICF a delegated BCRC-WA trial staff and PI will review eligibility. The Participant will be emailed their unique survey code ID with a link to the SurveyMonkey questionnaire to complete within 42 days of the consent signature. It is anticipated that this will take them 15-30 minutes overall. The trial data collected will only be analysed after recruitment is complete and all data has been collected. It is clearly stated in the Patient Informed Consent that data is not collected for treatment purpose. The trial recruitment period is planned to last 6-12 months, the expected duration of the project is January 2018 to January 2020. It is anticipated that 200 participants will be recruited.

Myopia, also known as short-sightedness, is a condition of the eye that is said to affect nearly a quarter of the world population. Whilst spectacles and contact lenses compensate for the myopia and allow the eye to see clearly, they do not control the increase in eye growth that is responsible for myopia. As a result, one is required to change their spectacles or contact lenses on a regular basis to be able to see clearly. Furthermore, the more the short-sightedness progresses, the greater the risk of complications such as retinal detachment, glaucoma and myopic macular degeneration. Recent research has shown that experimental contact lenses have the potential to slow the progression of myopia by 25 to 40% on average in a group of Chinese children. These lenses have a unique design profile that is intended to discourage the eye from further growth that leads to more myopia. This study aims to find out whether we can slow down the progression of short-sightedness in Australian children when experimental contact lenses are worn compared to standard commercially-available single vision contact lenses (1-Day Acuvue Moist, Johnson & Johnson Vision Care). To achieve this, the experimental contact lens will be worn in one eye and the standard single vision lens in the other eye over a period of 1 year. The lenses will be swapped between the eyes after 6 months.

This project evaluates an innovative model involving the delivery of psychological interventions by mental health trainees (MHTs) to residents with mild to moderate dementia. Interventions are provided to residents over 6 months (approximately 20 face-to-face sessions). Training in understanding dementia is also provided to their caregivers (family and friends) and to facility staff. In addition, caregivers are invited to join a monthly support group. Hence, the treatment involves a systemic approach involving residents, their caregivers and facility staff. Using a cluster-randomised controlled trial, this project compares the effectiveness of the model over and above usual practice, for improving depression and anxiety levels in residents with dementia.

‘A good recovery’ after anaesthesia and surgery is a key objective for patients and their treating team. It is not simply avoidance of complications, but also freedom from discomfort, postoperative nausea, and a rapid return to preoperative levels of function and psychological wellbeing. Delayed or incomplete recovery can have wide-ranging effects on an individual and those around them. The concept of a ‘good recovery’ is patient-centred, thus it is the patient’s assessment of their recovery that is of interest. Our aim is to determine whether stage of menstrual cycle affects quality of recovery after surgery in premenopausal women. Cycle stage will be measured by questionnaires and preoperative hormone blood levels. Quality of recovery will be assessed on the day after surgery by a patient-reported questionnaire which assesses pain, physical comfort, physical independence, emotions and psychological support. This study may provide information on why women generally have a worse recovery after anaesthesia and surgery when compared with men. If a link between menstrual cycle and postoperative recovery is found, women could choose the best time for elective surgery, to improve recovery, reduce pain, nausea and vomiting, as well as limit the side-effects of treatment of these conditions. The study's findings may encourage research into quality of recovery in peri- and postmenopausal women receiving hormone replacement therapy, a group who typically undergo more extensive surgery with a prolonged recovery. This study will be undertaken at Epworth HealthCare, a large tertiary healthcare organisation in Victoria, Australia. The researchers are anaesthesia and women’s health clinicians with an interest in patient-centred clinical outcomes research.

Aim: This experimental study will explore whether breaking up prolonged sitting is an effective strategy in reducing glucose, insulin and androgen markers in women with polycystic ovary syndrome (PCOS). Participants: 22 women of reproductive age (aged 18-45 years), a BMI between 25-35 kg/m2 and with medically diagnosed polycystic ovary syndrome (PCOS). Study design: Crossover trial of two 3-hour laboratory-based interventions involving prolonged sitting (control, SIT); and sitting with simple resistance activity breaks (SRA). Primary outcomes: Glucose incremental area under the curve (iAUC), changes in pre and post insulin and androgen levels Expect outcomes: It is hypothesised that compared to the SIT condition, the SRA condition with have reduced glucose iAUC, and post insulin and androgen levels. The study outcomes will help to better understand the potential importance of reducing sedentary behaviour in women with PCOS, and provide an additional lifestyle strategy in reducing their risk of future type 2 diabetes and cardiovascular disease (CVD).

The UP LATE service will provide a senior medical and nursing team to facilitate pro-active patient management out of hours, provide senior decision making and leadership to current after-hours personnel and improve organisational throughput. There will be a specific focus on better identifying and proactively reviewing "Patients of Concern" after-hours, including some pre-specified cohorts that have been identified organisationally as being at higher risk of clinical deterioration. There is limited evidence on the value of high quality after-hours leadership and clinical coordination. This initiative will be the first time such a service has been attempted for the Royal Brisbane and Women's Hospital, Queensland and a key output upon completion is to furnish data on the potential benefits to patients, staff and the organisation.

The Wound Healing in Patients with Venous Leg Ulcer Observational Cohort Study is a prospective multicentre observational cohort study that has been designed to follow patients with a venous leg ulcer who are deemed ineligible when screened for the ASPiVLU Study. This observational cohort study will gather real world evidence about time to healing in people with venous leg ulcers who are unable to be recruited or refuse to participate in the ASPiVLU RCT. The observational cohort study will take advantage of the screening conducted for the RCT to identify patients for inclusion in the observational cohort study which will collect data from 300 patients by accessing their medical records twice and asking them to complete a questionnaire at three time points. As with the ASPiVLU RCT, the primary objective is to determine wound healing within 12 weeks from the baseline screening visit. The secondary objective is to examine factors related to ulcer healing and recurrence within 24 weeks.

The primary purpose of the study is to evaluate the efficacy of probiotic and prawn oral immunotherapy compared to placebo in achieving sustained unresponsiveness. 8 weeks post end of treatment phase the participants will be challenged to test if they have achieved sustained unresponsiveness. The trial will include proven prawn allergic people from 5 to 30 years of age. They will be randomised 1:1 into active and placebo groups. The treatment phase will last for 18 months. The trial will last for 5 years.

Knee osteoarthritis affects around 25% of adults over 55. While exercise is the recommended primary intervention, pain, deconditioning and fear of falling impacts on exercise adherence, and adds to the disability cycle. A feasibility study, using quantitative and qualitative methods, will be undertaken determining viability of a larger clinical trial. A Feldenkrais Method intervention, using guided ‘awareness through movement’ lessons, will be used aiming to minimise pain-related habitual patterns, and improve sensorimotor planning and mobility. Fifteen participants (55yrs+) will be recruited from the community and randomised to a control or intervention group, with a cross-over arm. Three to 4 movement workshops of ~ 3hrs duration will be undertaken, with a control physical activity diary. Pre/post and follow-up measures will be undertaken at week 1, 4, 8 and 12. Clinical and patient reported measures will be used, and exit focus group / interviews to evidence a larger robust clinical trial.