Carolina Dragica Weller

Management of Patients With Venous Leg Ulcers: Challenges and Current Best Practice

Introduction It is well documented that the prevalence of venous leg ulcers (VLUs) is increasing, coinciding with an ageing population. Accurate global prevalence of VLUs is difficult to estimate due to the range of methodologies used in studies and accuracy of reporting. (1) Venous ulceration is the most common type of leg ulceration and a significant clinical problem, affecting approximately 1% of the population and 3% of people over 80 years of age (2) in westernised countries. Moreover, the global prevalence of VLUs is predicted to escalate dramatically, as people are living longer, often with multiple comorbidities. Recent figures on the prevalence of VLUs are based on a small number of studies, conducted in Western countries, and the evidence is weak. However, it is estimated that 93% of VLUs will heal in 12 months, and 7% remain unhealed after five years. (3) Furthermore, the recurrence rate within 3 months after wound closure is as high as 70%. (4) (-6) Thus, cost-effective adjunct evidence-based treatment strategies and services are needed to help prevent these ulcers, facilitate healing when they occur and prevent recurrence. The impact of a VLU represents social, personal, financial and psychological costs on the individual and further economic drain on the health-care system. This brings the challenge of providing a standardised leg ulcer service which delivers evidence-based treatment for the patient and their ulcer. It is recognised there are variations in practice and barriers preventing the implementation of best practice. There are patients not receiving appropriate and timely treatment in the initial development of VLUs, effective management of their VLU and preventing recurrence once the VLU has healed. Health-care professionals (HCPs) and organisations must have confidence in the development process of clinical practice guidelines and have ownership of these guidelines to ensure those of the highest quality guide their practice. These systematic judgments can assist in policy development, and decision making, improve communication, reduce errors and improve patient outcomes. There is an abundance of studies and guidelines that are available and regularly updated, however, there is still variation in the quality of the services offered to patients with a VLU. There are also variations in the evidence and some recommendations contradict each other, which can cause confusion and be a barrier to implementation. (7) The difference in health-care organisational structures, management support and the responsibility of VLU management can vary in different countries, often causing confusion and a barrier to seeking treatment. These factors further complicate the guideline implementation process, which is generally known to be a challenge with many diseases. (8).

A systematic review of medication non-adherence in persons with dementia or cognitive impairment

Background Adherence to medication is vital for disease management while simultaneously reducing healthcare expenditure. Older persons with cognitive impairment (CI) are at risk for non-adherence as cognitive processes are needed to manage medications. This systematic review focuses on the relationship between medication non-adherence and specific cognitive domains in persons with CI, and explores determinants of medication non-adherence. When available, relationships and factors are compared with cognitively intact populations. Methods A seven database systematic search of studies published between 1 January 1949–31 December 2015 examining medication non-adherence in community dwelling persons with CI or dementia was conducted. Articles reporting medication non-adherence in people with CI or dementia in the community, with or without caregiver supports were eligible for inclusion. Papers reporting adherence to treatments in cognitively intact populations, populations from hospital or institutional settings, for non-prescribed medication or those describing dementia as a factor predicting medication non-adherence were excluded. Data on study and population characteristics, research design, data sources and analysis, specific cognitive domains, non-adherence prevalence, measurement of adherence, salient findings, factors associated with adherence and strategies to improve medication adherence were extracted. Study limitations included inconsistencies between data sources and definitions, resulting in a loss of fidelity in the value and comprehensiveness of data, as well as exclusion of non-pharmacological treatments and regimens. Findings Fifteen studies met inclusion criteria. Adherence among CI subjects ranged from 10.7%-38% with better rates of adherence in non-CI individuals. Medication non-adherence definitions varied considerably. New-learning, memory and executive functioning were associated with improved adherence and formed the focus of most studies. Multiple factors were identified as modulators of non-adherence. Conclusion This review highlights a gap in knowledge on how specific cognitive domains contribute to medication non-adherence amongst CI populations, and demonstrates the current focus is limited to two domains: memory and executive functioning.

Randomized clinical trial of three-layer tubular bandaging system for venous leg ulcers

The safety and efficacy of three‐layer (3L) tubular bandaging as a treatment for venous ulcer healing has not been evaluated despite its use in many clinical settings to treat people with venous leg ulcers. We evaluated the safety and efficacy of 3L tubular bandage compared with short‐stretch compression bandage to heal venous ulcers in a multicenter, open‐label, parallel‐group, randomized controlled trial. We randomized 45 patients with venous leg ulcers of up to 20 cm2 area and an ankle brachial pressure index of >0.8 from hospital outpatient wound clinics in Victoria and Queensland, Australia. We measured time to healing and percentage reduction of wound size from baseline to week 12. Secondary outcomes were proportion of ulcers healed, self‐reported compliance of compression bandage, and health‐related quality of life, costs, recurrence rates, and adverse events. A total of 27 ulcers healed, the proportion of healed ulcers was higher for the 3L group (17/23 [74%] vs. 10/22 [46%]) (p = 0.05). Reported bandage tolerance at all treatment visits was 21 (91%) in 3L group vs. 17 (73%) (p = 0.10). There was no difference between the groups in adverse events. Costs were substantially less in 3L group.

Improving venous ulcer healing: designing and reporting randomised controlled trials.

The randomised controlled trial (RCT) is often considered the gold standard for judging the benefits of treatments. The application of randomised controlled clinical trials to treatments of venous ulcer healing has lagged behind that of other areas of medicine. To interpret the results of an RCT, readers must understand a variety of aspects of their design, analysis and interpretation.

Protocol for a pilot randomised controlled clinical trial to compare the effectiveness of a graduated three layer straight tubular bandaging system when compared to a standard short stretch compression bandaging system in the management of people with venous ulceration: 3VSS2008

BackgroundThe incidence of venous ulceration is rising with the increasing age of the general population. Venous ulceration represents the most prevalent form of difficult to heal wounds and these problematic wounds require a significant amount of health care resources for treatment. Based on current knowledge multi-layer high compression system is described as the gold standard for treating venous ulcers. However, to date, despite our advances in venous ulcer therapy, no convincing low cost compression therapy studies have been conducted and there are no clear differences in the effectiveness of different types of high compression.Methods/DesignThe trial is designed as a pilot multicentre open label parallel group randomised trial. Male and female participants aged greater than 18 years with a venous ulcer confirmed by clinical assessment will be randomised to either the intervention compression bandage which consists of graduated lengths of 3 layers of elastic tubular compression bandage or to the short stretch inelastic compression bandage (control). The primary objective is to assess the percentage wound reduction from baseline compared to week 12 following randomisation. Randomisation will be allocated via a web based central independent randomisation service (nQuery v7) and stratified by study centre and wound size ≤ 10 cm2 or >10 cm2. Neither participants nor study staff will be blinded to treatment. Outcome assessments will be undertaken by an assessor who is blinded to the randomisation process.DiscussionThe aim of this study is to evaluate the efficacy and safety of two compression bandages; graduated three layer straight tubular bandaging (3L) when compared to standard short stretch (SS) compression bandaging in healing venous ulcers in patients with chronic venous ulceration. The trial investigates the differences in clinical outcomes of two currently accepted ways of treating people with venous ulcers. This study will help answer the question whether the 3L compression system or the SS compression system is associated with better outcomes.Trial RegistrationACTRN12608000599370

Interactive dressings and their role in moist wound management

Abstract In this chapter, we have reviewed the technological advances in the development of interactive wound dressings. Since the time when the value of a moist wound environment in wound healing process was recognised, the primary purpose of dressings has changed from reducing moisture to maintaining moisture. The balance of moisture is critical to healing and this principle has been the driving force in the development of products that are currently available, such as hydrogels, hydrocolloids, alginates, and foams and films. Many interactive dressings work actively with wound properties, such as wound exudate, tissues, cells and some growth factors and, in addition to maintaining moisture, enhance healing process. We have provided suggestions on how to select the most appropriate interactive dressing product and discussed the latest studies and reviews on the effectiveness of selected products in wound management.

Effects and associations of nutrition in patients with venous leg ulcers: A systematic review

AIMS To identify the associations and effects of nutritional characteristics and interventions on ulcer outcomes in adult patients with venous leg ulcers. BACKGROUND Venous leg ulcers are the most prevalent type of lower limb ulcer; however, little evidence exists regarding the relationship between nutritional status and ulcer healing. DESIGN A systematic search of English language articles was conducted using the Cochrane Collaboration Handbook for Systematic Reviews of Interventions. DATA SOURCES A search of databases Ovid MEDLINE, EMBASE, Cochrane, CINAHL and Scopus was performed for studies published between January 2004 - May 2017. REVIEW METHODS Quality of the included studies was assessed using the Cochrane Collaborations Risk of Bias Assessment tool and the relevant Joanna Briggs Institute quality appraisal checklists. RESULTS Twenty studies met the inclusion criteria. All participants had Clinical Aetiology Anatomy Pathophysiology classification C5 (healed) or C6 (active) ulcers. Studies were conducted in a range of clinical settings with relatively small sample sizes. The majority of patients were overweight or obese. Increased body mass index was associated with delayed wound healing. Vitamin D, folic acid and flavonoids were associated with some beneficial effects on ulcer healing. Dietary intakes of omega-3 fatty acids, vitamin C and zinc were low for some patients. CONCLUSION Current evidence suggests that venous leg ulcer patients are more likely to be overweight or obese. However, evidence for weight management improving wound healing is lacking. Micronutrients, including vitamin D and folic acid, may improve wound healing in at-risk patients.

Aspirin treatment for chronic wounds: Potential beneficial and inhibitory effects.

Aspirin is a generally well‐tolerated drug that is now widely used in aged patients for its antithrombotic action. Aspirin works through several pathways to reduce inflammation, fever and to alter platelet activity. The scientific literature suggests that inhibition of the cyclooxygenase enzymes by aspirin or other nonsteroidal anti‐inflammatory drugs may be deleterious to normal wound repair processes and result in healing inhibition. However, novel effects of aspirin on other pathways that regulate inflammation and repair have been reported more recently. These pathways, including inhibition of inflammatory second messengers and transcription factor pathways and production of anti‐inflammatory, pro‐resolution factors (lipoxins), provide a possible explanation for beneficial effects of aspirin in chronic wound healing. There have been limited studies to date that provide good evidence to support aspirin use in chronic venous leg ulcers but this may change as we see results from randomized trials that are currently being undertaken. In this article, we look at possible effects that aspirin administration may have on venous leg ulcer healing and the expanding knowledge of potential beneficial effects of aspirin that operate via novel pathways. Though the literature suggests that aspirin treatment and cyclooxygenase inhibition may have deleterious effects in normal healing, it is possible that in chronic wounds that may be trapped in an inflammatory state that aspirin treatment may result in beneficial outcomes.

A review of coronial investigations into medication-related deaths in Australian residential aged care

Background: Residential aged care is a complex and challenging clinical setting where medication errors continue to occur despite efforts to improve medication safety. No studies have sought to review and synthesize coronial investigations into medication‐related deaths in Australian residential aged care facilities (RACFs). Objective: To review coronial investigations into medication‐related deaths in Australian RACFs. Methods: A national review of medication‐related deaths between July 2000 and July 2013 reported to Australian Coroners was performed. Data were extracted from the National Coronial Information System and errors categorized according to stages of the medication management cycle. Results: The database search identified thirty coronial investigations into deaths. Single medication classes were implicated in 22 deaths; including opioids (n = 7), antipsychotics (n = 4) and antidepressants (n = 3). Eight deaths resulted from two or more medication classes. Thirteen deaths reported stages of medication errors, including administration (n = 9) and monitoring (n = 4). Coroners made recommendations following three deaths; including education and training on dose administration aids, regulation of personal care workers, and protocol‐based renal function monitoring for residents taking digoxin. Conclusions: Deaths involving high‐risk medications occurred primarily at the stages of administration and monitoring. Few investigations resulted in specific recommendations, however it is unknown whether these were implemented.

What is the effect of exercise on wound healing in patients with venous leg ulcers? A systematic review

Standard best practice for the treatment of venous leg ulcers (VLUs) is compression bandaging of the lower leg to reduce hydrostatic pressure. There is considerable variation in reported healing rates when using this gold‐standard approach; therefore, a systematic and robust evaluation of other interventions is required. Exercise interventions, in addition to standard compression therapy, could improve wound‐healing time and prevent their recurrence. We have conducted a systematic review to examine the effects of exercise on wound characteristics, including time to heal, size and recurrence, pain, quality of life, adverse events, and economic outcomes. This review was registered with PROSPERO 2016:CRD42016046407. A systematic search of Ovid Medline, Ovid EMBASE, Ovid CINAHL, The Cochrane Library, PsycINFO, Web of Science, and PEDro was conducted on January 30, 2017, for randomised control trials to examine the effects of exercise on time to heal, size and recurrence, pain, quality of life, adverse events, and economic outcomes. Six studies met the inclusion criteria, but all had design flaws leading to biases, most commonly performance and selective reporting bias. Three studies compared a progressive resistance exercise programme (PREG) plus compression with compression alone for a period of 12 weeks. Low‐quality evidence indicates the following: possibly no difference in the proportion of ulcers healed (risk ratio [RR] 1.14, 95% CI 0.71 to 1.84, I2 36%; 3 trials, 116 participants); probably no difference in quality of life (mean difference [MD] 3 points better on 100 point scale with exercise, 95% CI −1.89 to 7.89, 1 trial, 59 participants); possible increase in the risk of adverse events with exercise (OR 1.32, 95% CI 0.95 to 1.85, 1 RCT, 40 participants); and no difference in ankle range of motion and calf muscle pump. Evidence was downgraded due to susceptibility to bias and imprecision. Recurrence, pain, and economic outcomes were not measured in these trials, and time to healing was measured but not fully reported in 1 trial. We are uncertain of the effects of other interventions (community‐based exercise and behaviour modification, ten thousand steps, supervised vs unsupervised exercise) due to the availability of low‐ or very low‐quality evidence only from single trials. The review highlights the need for further research, with larger sample sizes, to properly address the significance of the effect of exercise on VLU wound characteristics.