ANZCTR search results

Background Postoperative delayed wound healing impacts on patient wellbeing and return to normal life and can result in intrinsic and extrinsic complications. Unilateral mastectomy impacts on patient healing as well as body image perspective and is further complicated by the diagnosis of cancer. Aim of the study The purpose of the study is to determine the effectiveness of negative pressure wound therapy on seroma formation following unilateral mastectomy. Who is it for? The study is for females about to undergo an elective unilateral mastectomy that consent to be in the study. Study participants are randomly allocated (by chance) to one of two groups. Participants in one group will receive a negative pressure dressing applied to their wound for 7 days, whilst participants in the other group will receive a standard surgical dressing. Patients will be followed-up for up to 30 days postoperatively to determine seroma formation during the post operative period.

Attention modification training refers to training participants to attend away from emotionally relevant information. In the pain literature, ABM has been shown to improve pain outcomes. However, all research has used the dot-probe paradigm, the reliability of which has been questioned. This project aims to trial a novel ABM procedure using painful faces.

This study will investigate the effect of modifying interpretations of ambiguous faces on performance of a painful task. Specifically, we will compare how effective training participants to interpret an ambiguous facial expression as happy compared to painful. We are interested to know whether this training is more effective when instructions are explicit versus implicit.

With the tight work schedules of the dental workers, we propose that small daily doses of neck/shoulder specific exercise is an optimal approach to minimise the risk of neck/shoulder pain for these workers. This project will test the feasibility and benefits of a 10-week workplace-based exercise intervention in a population of dental health students in their clinical environment.

A primary objective of orthodontic treatment is to achieve a functional and aesthetic outcome efficiently and with minimum root resorption. Preliminary research has shown promising results with micro-osteoperforations and accelerated orthodontic tooth movement. Being a relatively recent adjunct to orthodontic treatment, further research is required to gain insight into the effects of micro-osteoperforation on tooth movement as well as on root resorption. The aim of the proposed investigation is twofold. The first part consists of applying buccally directed orthodontic forces to the upper 1st premolars to compare the amount of root resorption that occurs with normal orthodontic tooth movement, with that which occurs with orthodontic tooth movement in areas treated with micro-osteoperforations. The micro-osteoperforations will be applied using a disposable appliance designed for this purpose by Propel Orthodontics. The Propel device is a TGA approved, FDA registered medical device specifically designed to create micro-osteoperforations. The second part consists of quantitatively measuring the rate of bodily canine retraction with normal orthodontic tooth movement, and orthodontic tooth movement associated with micro-osteoperforations. The hypothesis of this research project is that micro-osteoperforations will minimise orthodontic root resorption while allowing accelerated rates of orthodontic tooth movement. The proposed investigation will be a Prospective Cohort study involving 12-14 subjects. The first part of the project involves placing orthodontic braces only on the upper posterior teeth. Using a split-mouth design, one side will be randomly made control, while the other will be the experimental side in which micro-osteoperforations will be placed. Three perforations in a vertical alignment will be placed on both the mesial and distal aspects of the upper first premolar. Orthodontic force will be applied to the first premolars bilaterally for 4 weeks, after which the teeth will be extracted as part of the patient’s ongoing orthodontic treatment. These extracted teeth will then be scanned with a MicroCT scanner and the extent of resorption measured. Patients will also be asked to record their level of discomfort on the experimental and control side following the placement of braces and micro-osteoperforations. The second part of the study involves placing full braces on the subjects with 24 weeks of aligning and levelling teeth. After this period, another three perforations in a vertical alignment will be placed distal to the upper canine on the experimental side and the rate of canine retraction will be compared to the control side. Patients will be assessed and tooth movement measured off study models every 2-4 weeks, over an 8-week period. Conclusion: Root resorption is a significant consequence of orthodontic treatment. As micro-osteoperforations is a new adjunctive treatment to orthodontics, further research is needed to assess its effect on root resorption and to confirm its association with accelerated orthodontic tooth movement.

Tourette Syndrome (TS) is a neurodevelopmental disorder with childhood onset, characterised by the presence of both motor and vocal tics (American Psychiatric Association, 2013). Once thought to be a rare disorder, the prevalence of TS is now understood to be approximately 1% in the general population (Robertson, Eapen & Cavanna, 2009). A growing body of evidence suggests that noninvasive brain stimulation techniques, including transcranial Magnetic Stimulation (TMS) and transcranial Direct Current Stimulation (tDCS), may have a promising role in the diagnosis, monitoring and treatment of a variety of neurological and psychiatric conditions, including TS. For example, TMS has been found to be safe and effective in the treatment of TS among children and adolescents (Le, Liu, Sun, Hu & Xiao, 2013; Wu, Shahana, Huddleston, Lewis & Gilbert, 2012). With the exception of a report on two adult cases (Mrakic-Sposta et al., 2008), no study to date, however, has investigated tDCS as a therapeutic intervention for TS, despite previous research demonstrating its safety and tolerability for children and adolescents with other neurological and psychiatric disorders (for a review, see Krishnan, Santos, Peterson & Ehinger, 2015). This clinical pilot study will examine the feasibility and safety of tDCS for treatment of TS in individuals aged over 12 years.

The infant born very preterm (23-31 weeks gestation) is at high risk of an adverse neurodevelopmental outcome (10% cerebral palsy, 50% learning and behavioural difficulties at school age) which, if present, results in costs of billions of dollars annually in Australia. Currently there is no accurate way to either predict the motor, cognitive and neurobehavioural outcomes in these high-risk infants or to adequately monitor structural and functional brain development. Cerebral palsy is often not diagnosed until the second year of life and cognitive and educational disability even later. As a result, early intervention to target those at most risk is not possible. However, in the several months after very preterm birth, the brain is at its maximal capacity for neuroplasticity and repair, which offers a window of opportunity for effective and safe interventions to be implemented to improve outcomes. The purpose of this research is to learn which tests (clinical, MRI and EEG) can be used at 30 weeks and 40 weeks, to accurately identify which babies may have problems later in life, so that those babies and their families can be provided with the help they need as early as possible. We aim to predict adverse neurodevelopment earlier and more accurately than currently possible in a cohort of 237 babies using: (i) advanced brain MRI to determine the structural wiring diagram of the brain ('brain connectome'), (ii) dense array EEG to establish the functional activity or electrical 'traffic' being carried on the main branches of the connectome and (iii) structured clinical neurodevelopmental assessments to provide a cutting edge view of the state of brain development. We aim to achieve this in a prospective longitudinal cohort study of 200 preterm infants born <31 weeks GA, and a reference group of 37 healthy term-born infants. Infants will undergo a brain MRI at 30 and 40 weeks GA to develop our understanding of the brain structure and maturation that occurs between these time points. A combination of neurological, neuromotor and neurobehavioural assessments will be performed at 30 and 40 weeks GA to understand the relationship between brain structure and function. These data will be compared to clinical neurodevelopmental assessments at 3 months, 12 months and 24 months corrected age. We will merge two research teams using Australia's only two MRI compatible incubators (RBWH and Monash Medical Centre) to establish the role of cutting edge approaches in clinical assessment, MRI and EEg methods to improve neurodevelopmental outcomes for preterm infants.

Aims: Bronchiolitis is an extremely common cause of respiratory illness in infants caused by viral infection. The primary aim of this study is to determine whether treatment with nitazoxanide (NTZ) reduces the duration and severity of respiratory symptoms caused by bronchiolitis. Justification: Bronchiolitis affects over a third of infants in their first two years of life, and in Australia approximately 5,000 infants are hospitalised every year with the condition (Garcia et al. 2010). This is estimated to cost the healthcare system between 32 and 62 million dollars per year (Deshpande & Northern 2003). Infants who are born prematurely, or who have lung disease or heart disease are at the highest risk of developing bronchiolitis and also have the most severe disease. Bronchiolitis increases the risk of subsequently developing recurrent wheezing and asthma in childhood (Shay et al. 1999). An effective treatment would be of enormous benefit, not only by reducing infant suffering, but also by reducing the impact on parents and the healthcare system and the long-term consequences of infection. Participant Groups: This study will involve 124 infants between the ages of 1 and 12 months with a clinical diagnosis of bronchiolitis (62 in each study arm). Project Design: This study is a phase II double-blind randomised, placebo-controlled clinical trial of oral nitazoxanide for the treatment of bronchiolitis. Methods: Parents of infants presenting to Princess Margaret Hospital and diagnosed with bronchiolitis will be invited to participate. Following a full explanation of the study, informed consent will be taken from interested parents. A brief clinical history of the illness will be taken, and the infant assessed for respiratory distress using a validated scoring system (the Respiratory Distress Assessment Instrument). A painless swab will be taken from the front of the infant’s nose to try and detect the virus that has triggered the illness. Infants will then be allocated at random (similar to tossing a coin) to receive either treatment with NTZ or placebo for five days. Infants will be reviewed after three days of treatment, and their respiratory distress score repeated. The change in the score, combined with a change in respiratory rate will be used to calculate the Respiratory Assessment Change Score (RACS). In order to assess if NTZ is a useful treatment for bronchiolitis the RACS will be compared between the placebo and the NTZ groups. Symptoms over the first week of illness and oxygen requirement will also be compared using a parental completed diary card. To see if NTZ reduces the amount of virus present, a nasal swabs at day 3 and day 5 will be collected and the viral load compared with that at baseline. For infants that need to be admitted to hospital, the amount of medical support need ed will be recorded (for example, the need for oxygen therapy) as well as the duration of hospitalisation. The number of times that the infant has to come back to hospital for either bronchiolitis or wheeze will be recorded over the six months after treatment using electronic hospital records. Expected Outcomes: This study will determine whether NTZ is an effective empirical treatment for bronchiolitis. It will also help us to understand what effect NTZ has on the amount of virus present and how viral load changes over the course of the disease. If this study shows that NTZ is a useful treatment, then a larger study will be conducted enrolling infants that present to primary care facilities.

Critically ill tracheostomised mechanically ventilated patients are often left voiceless due to air bypassing their vocal folds. There are speaking valves that can be used in this population to restore verbal communication, however they are not widely used with ICU patients due to concerns about the required cuff deflation causing a leak in the ventilation circuit and potentially leading to derecruitment of the patients' lungs. This in turn would be deleterious towards patients weaning off mechanical ventilation. This study is looking at assessing patients' lung mechanics before, during and after the speaking valve use to guide us on respiratory physiology and advise us on future best practice.

Peripheral intravenous cannula (PIVC) insertion is the one of the most common clinical interventions performed in the Emergency Department (ED) worldwide. Improving the first time insertion success rate and dwell time of PIVCs inserted in EDs can prevent repeat needle insertions. A number of factors have been identified as predictor’s of insertion failure and premature device failure. However, none have focused on the patient's journey with PIVC from ED to hospital admission. Purpose: This study proposes to determine the predictors of first time PIVC insertion success in ED and risk factors for PIVC failure for ED patients admitted to the hospital wards. Methods: A prospective observational cohort study of PIVC insertions in a patient population presenting to ED, with follow-up of subsequent admissions to hospital wards. Data in relation to clinician and patient risk factors will be collected from medical records and observations, as well as device information. Multivariable regression analyses will be sued to identify factors associated with insertions success and PIVC failure Results: The projected sample size n=1000 PIVC insertions will provide sufficient power to determine the association between risk factors and first-time insertion success and premature device failure. Conclusion: This study will provide new evidence to improve insertion success rates in ED and identify strategies to reduce premature device failure for patients admitted to hospital wards with PIVC.