ANZCTR search results

Extracorporeal shockwave therapy (ESWT) is a new technology in the care of chronic non-healing wounds. The technology delivers high-energy pressure waves into the wound thereby enriching the ulcer with adequate blood through formation of new blood vessels. It also inhibits infection with its antibacterial property. Furthermore, it stimulates the body to produce natural growth factors which helps in repairing the damaged tissues of the wound. Recently, ESWT was reported to be effective in the initiation and acceleration of wound healing in various clinical settings including longstanding diabetic foot ulcers. The effectiveness of ESWT in wound healing, especially in treatment of diabetic foot ulcers has been demonstrated in numerous trials (1-2). It has been shown to be more effective value for money compared to hyperbaric oxygen therapy in management of chronic diabetic wounds (3). There are evidences demonstrating reduced length of stay for admitted patients when using this treatment model (3-4). Its safety profile has been proven in various studies (1-4). Numerous scientific investigations have been conducted on biological mechanism of action of ESWT in animals and humans and both proved to be safe and effective (5-6). Furthermore, it has been demonstrated that ESWT therapy achieves long-term healing results in diabetic wound care (7). Thus using this technology at The Townsville Hospital would likely improve the weighted activity unit per bed day figure for medical patients by increasing the total bed days saved, as that capacity will be filled by current access block / unmet demand of the chronic diabetic foot wounds at the hospital. In spite of these facts, ESWT technology has not been utilised in the care of diabetic foot ulcer patients in Australia in general and at The Townsville Hospital in particular. This is despite the fact that this technology is non-invasive, simple to use, well tolerated by patients, and only needs to be administered on fortnightly basis whereas even more invasive therapies need more frequent administration. Furthermore, ESWT is applied through an unfocused applicator which assures an almost painless treatment with no anaesthesia required and each therapy session only taking about 10 to 30 minutes. The main objective of this study was to evaluate wound healing rate and anti-inflammatory effect of shockwave therapy in subjects with diabetic foot ulcer at the Townsville Hospital, Australia. References 1. Wang C, Kuo Y, Wu R et al. J Surg Res. 2009; 152: 96-103. 2. Moretti B, Notarnicola A. et al. BMC Musculoskeletal Disorders 2009, 10:54, 1-8. 3. Wang CJ, Wu RW, Yang YJ. Diabetes Res Clin Pract. 2011 ;92(2):187-93. 4. Saggini R, Figus A, et al.. Ultrasound Med Biol. 2008 Aug;34(8):1261-71. 5. Mittermayr R, Antonic V, et al. Wound Repair Regen. 2012;20(4):456-65. 6. Kuo YR, Wang CT, et al. Wound Repair Regen. 2009;17(4):522-30. 7. Wang CJ et al. J Surg Res. 2014;189(2):366-72.

Recurrent or relapsing Clostridium difficile infection (CDI) is a significant and increasing health problem within Australia and a leading cause of gastrointestinal death within western countries. Standard antibiotic therapy has a high failure and relapse rate with further relapses becoming more likely. High quality studies published out of Europe have shown that faecal microbiota transplantation (FMT) for relapsing or recurrent CDI is highly efficacious and appears to be safe. However there is no data available for the use of FMT within an Australian population. We aim to recruit patients within Western Australia who have symptomatic recurrent or relapsing CDI having failed at least two courses of standard antibiotic therapy and offer them either a related fresh screen FMT or unrelated frozen screened FMT. FMT donors will be screen for a wide variety of infectious and non-infectious disease by a gastroenterologist and infectious diseases consultant. Their faecal microbiota will then be suspended, filtered and resuspended before delivery to the recipient's colon either via a colonoscope or via a nasogastric tube if the recipient has contraindications for a colonoscopy. Recipients will then be reassesed in the outpatient clinic at weeks 2, 12, 26 and 52 to assess their response to FMT and its safety.

Femoroacetabular (hip) impingement (FAI) is a painful condition that commonly affects healthy active younger adults. It can limit their ability to continue playing sport and perform normal daily activities. It can be related to extra bone formation at the hip joint known as a cam deformity. Physiotherapy is one treatment people may use to reduce their symptoms and improve their function. This study aims to investigate the feasibility of a randomised controlled trial (RCT) to reduce pain and improve function in people with FAI. The study will compare the effects of two different physiotherapy treatment interventions.

This is a parallel randomised controlled trial comparing operative versus nonoperative management for recalcitrant greater trochanteric pain syndrome (GTPS). While the majority of cases of GTPS improve significantly or resolve with nonoperative management, there is no evidence that compares operative to nonoperative management when the condition is deemed recalcitrant (after 6 months of symptoms). We are looking to investigate the natural history of the condition (what occurs when no treatment is given over a period of time). To do this, we are comparing nonoperative management consisting only of advice to continue your normal daily life with surgical treatment for the condition. Current surgical standard of care for recalcitrant GTPS consists of endoscopic iliotibial band release and trochanteric bursectomy. The study aims to investigate whether surgical intervention leads to reduced pain and improved function compared with continued nonoperative management in the treatment of recalcitrant greater trochanteric pain syndrome. This study will be conducted as a randomised controlled trial with the control arm receiving advice to continue along their daily life for the period of the trial. The intervention arm will receive the current surgical standard of care, consisting of endoscopic iliotibial band release and trochanteric bursectomy. Our hypothesis is there will be an improvement in the pain and function in the intervention group receiving the surgery compared to the control group. We are hoping this will result in a change in standard practice for this group of patients, whereby patients with severe recalcitrant GTPS symptoms undergo an appropriate intervention for their pain. At the end of the trial, any patients with ongoing pain despite the continued non-operative treatment will be offered the surgical treatment if they desire.

Given relationships between meal patterns and glucose metabolism, cardiometabolic biomarkers may be beneficially altered by a reduction in energy consumed at the evening meal and increasing that consumed at breakfast. The purpose of the present study is to examine how manipulations to the distribution of energy throughout the day influences blood glucose and insulin metabolism, and appetite control, during periods of prolonged sitting in overweight/obese men and women. This study aims to recruit individuals who are overweight/obese as they are typically those who exhibit tendencies of developing type 2 diabetes and they represent an important target group for evaluating strategies for disease prevention.. It is hypothesised that by increasing the energy intake at the beginning of the day (i.e. a large breakfast) will better distribute the glucose load throughout the day, when not participating in any physical activity (i.e. prolonged sitting).

Diabetes foot ulcer (DFU) is a serious complication of diabetes that leads to prolonged hospitalisation and >80% of diabetes-related lower limb amputations (1). Although a number of health disparities exist between rural and urban areas in Australia, management of diabetes foot ranks as one of the most significant health concerns (2). Compared to Australian major cities, rural/remote areas experience two to three times higher rate of hospitalisation and limb amputation due to diabetes (3). Despite high prevalence of diabetic foot complications in rural/remote areas, there are surprisingly no special programs aimed at reducing the burden of the disease. Significant challenges such as access to the health care centres and staffing limitations have made quality of care comparisons between rural and urban centres difficult. Currently subjects with DFU living in rural/remote areas in the region have to travel long distances to Townsville Hospital Diabetes Centre (THDC) on weekly basis for wound care. The annual Medicare cost for care in patients with diabetes who have foot ulcer is 3 times that of patients with diabetes who do not have ulcer, with inpatient care accounting for 70% of ulcer care costs (4). A program that effectively manages foot ulcers and reduces hospital admissions could substantially reduce costs of care in diabetes. Use of telemedicine may help solve the scarcity of specialist diabetes wound care in such underserved communities in our region. Objectives: to assess clinical and economic impacts of telemedicine in management of foot ulcers in rural/remote areas of North Queensland. References 1. http://www.aihw.gov.au/diabetes-indicators/lower-limb-amputations/ 2. Australian Institute of health and Welfare 2012-2014 http://www.aihw.gov.au/ 3. Queensland Health Patient Travel Subsidy Scheme: http://www.health.qld.gov.au/ptss/

To see if intra uterine installation of a local anaesthetic at end of Hysteroscopy procedure reduces post op pain and delay in recovery

A RCT to compare clinical examination alone versus clinical examination and ultrasound for accuracy of fetal head position prior to vacuum birth.

Pressure injury prevalence in intensive care units remains high, 13.1% to 28.7%, despite efforts to stem the prevalence through the implementation of best practice guidelines. Pressure injuries are avoidable, but medical attention goes first and foremost to the task of stabilising the patient’s condition. Pressure injuries occur when patients are immobilised on admission to hospital as a precautionary measure until spinal injury is excluded, during lengthy hours of surgery and during recovery. Recently, interest in a remarkably simple approach that can reduce the incidence of pressure injury has emerged. The strategy—prophylactic application of a dressing product to areas at risk of pressure injury—has been seen to almost eliminate the incidence of pressure injury on the sacrum and heel and resulted in acute care expenses that were 3.6 times cheaper than usual care. It is suggested that the reason the dressings are effective is because they manage the microclimate of the skin and, specifically, they reduce the amount of moisture on the skin. Though a systemic review of existing trials support the efficacy of this clinical approach, this theory of microclimate management has not, however, been tested in clinical trials to date. More research is needed to confirm prior study results and test if the intervention does alter the microclimate. Participants in this study (n=336) will have been admitted to an Intensive Care Unit (ICU). All patients meeting the eligibility criteria will be randomised to either the prophylactic dressing and standard care study condition (intervention) or the standard care study condition (control). Dressings will be applied to the sacrum, both heels, and the occiput if shaved. The dressing will remain in place for the participant’s duration in the ICU. The primary outcome measure will be the occurrence of a pressure injury in these anatomical locations during their stay in the ICU. Epidermal hydration, erythema and temperature of the pressure prone areas will be assessed for every study participant at scheduled repositioning of the participant during day shift hours. Monitoring of PI’s elsewhere on the body and during the entire acute episode will be undertaken. The cost of the ICU stay and the full acute episode will be monitored. The incidence of PI development and changes in microclimate state at each anatomical location and cost of care will be compared between the intervention and control groups.

The aim of the project is to test the feasibility and effectiveness of the FitMindKit program to reduce symptoms of mental health problems in adults. FitMindKit is an online program that uses brief therapeutic modules (based on cognitive behavioural therapy) to reduce symptoms of common mental disorders (major depression, anxiety disorders, substance use disorders) and suicidal thoughts. Unlike existing internet programs, FitMindKit is tailored to the individual's mental health profile, taking account of multiple mental health problems using rapid screening methods. 570 adults, 18 years and over, with elevated symptoms of depression, anxiety, and/or substance use will be recruited from the community and randomised to receive one of three programs: (i) the FitMindKit program, (ii) a static, untailored version of the FitMindKit program, or (iii) an attention-matched control program containing general health information not directly related to mental health. We hypothesise that: (1) compared to users of the control program, users of both versions of the FitMindKit program will show a greater reduction of symptoms of depression, generalised anxiety, social anxiety, panic, alcohol and other substance use, and suicidal thoughts; (2) users of the tailored FitMindKit program will show a greater symptom reduction than users of the static FitMindKit program; (3) users of both versions of the FitMindKit program will report greater satisfaction than users of the control program; (4) users of the tailored FitMindKit program will have greater adherence to the program; and (5) the FitMindKit program will be cost-effective, through reduced need for primary care and mental health services.