Hospital-acquired pressure injury prevention in people with a BMI of 30.0 or higher: A scoping review.

AIM(S): To: (1) explore current best practices for hospital-acquired pressure injury prevention in high BMI patients; (2) summarize nurses' experiences in preventing and managing them; (3) explore the association between a high BMI and occurrence and severity of pressure injury. DESIGN: Exploratory. METHODS: Scoping review. DATA SOURCES: Ovid MEDLINE, EBSCO CINAHL Plus, JBI Evidence Synthesis, Scopus, Embase, clinical registries and grey literature (search dates: January 2009 to May 2021). RESULTS: Overall, 1479 studies were screened. The included studies were published between 2010 and 2022. Five interventional studies and 32 best practice recommendations (Objective 1) reported low-quality evidence. Findings of thematic analysis reported in nine studies (Objective 2) identified nurses' issues as insufficient bariatric equipment, inadequate staffing, weight bias, fatigue, obese-related terminology issues, ethical dilemmas and insufficient staff education in high BMI patients' pressure injury prevention. No association between hospital-acquired pressure injury occurrence and high BMI were reported by 18 out of 28 included studies (Objective 3). CONCLUSION: Quality of evidence was low for the interventional studies and best practice recommendations. IMPLICATIONS FOR THE PROFESSION AND/OR PATIENT CARE: Current (2019) International Pressure Injury Guideline to be used despite the low quality of evidence of most best practice recommendations. IMPACT STATEMENT: This study addressed hospital-acquired pressure injury prevention in high BMI patients. Greater proportion of studies in this review found no association between high BMI and occurrence of hospital-acquired pressure injury. Nurses need educational interventions on pressure injury prevention in high body mass index people, sufficient staffing for repositioning and improved availability of bariatric equipment. REPORTING METHOD: We adhered to relevant EQUATOR guidelines, PRISMA extension for scoping reviews. PATIENT OR PUBLIC CONTRIBUTION: No patient or public contribution. WHAT DOES THIS PAPER CONTRIBUTE TO THE WIDER GLOBAL CLINICAL COMMUNITY?: Larger clinical trials are needed on repositioning frequency, support surfaces, prophylactic dressings and risk assessment tools to inform clinical practice guidelines on pressure injury prevention in high BMI people. PROTOCOL REGISTRATION: Wound Practice and Research (https://doi.org/10.33235/wpr.29.3.133-139).

Nurses' experiences of hospital-acquired pressure injury prevention in acute healthcare services in Victoria, Australia: A qualitative study using the Theoretical Domains Framework.

We investigated nurses' experiences of hospital-acquired pressure injury (PI) prevention in acute care services to better understand how PI prevention may be optimised. We used the Theoretical Domains Framework to systematically identify barriers and enablers to evidence-based preventive practices as required by the International Guideline. This study was one element of a complex capacity building project on PI surveillance and prevention within the acute health service partners of Monash Partners Academic Health Science Centre, an accredited academic health partnership located in Melbourne, Australia. We adopted a qualitative descriptive design. We interviewed 32 nurses that provided care in intensive care units, general wards and COVID wards of four acute care services. Nurses were recruited from four large acute care services (three public, one private) located in Melbourne. Most of them worked with patients who were at high risk of hospital-acquired PI on a daily basis. Interview transcripts were coded and analysed using thematic analysis guided by the Theoretical Domains Framework. The domains referred to most frequently by all participants included: Knowledge, Skills, Social/Professional Role and Identity, Beliefs about Capabilities, and Environmental Context and Resources. The key barriers discussed by nurses included gaps in nurses' knowledge and skills related to identification and staging of PI, heavy nursing workload and inadequate staffing levels, stigma and self-blame related to PI identification, and exacerbating impacts of the COVID-19 pandemic. Main facilitators discussed were training programmes, nursing audits and feedback, and teamwork. Participants suggested improvements including accessible and tailored training, visual reminders, and addressing heavy workloads and emotional barriers nurses face. Investing in tailored training initiatives to improve nurses' knowledge and organisational changes to address low level staffing and heavy workloads are urgently needed to support nurses in delivering optimal care and preventing hospital-acquired PI.

Targeted care navigation to reduce hospital readmissions in 'at-risk' patients.

BACKGROUND: Care navigation is commonly used to reduce preventable hospitalisation. The use of Electronic Health Record-derived algorithms may enable better targeting of this intervention for greater impact. AIMS: To evaluate if community-based Targeted Care Navigation, supported by an Electronic Health Record-derived readmission risk algorithm, is associated with reduced rehospitalisation. METHODS: A propensity score matching cohort (5 comparison to 1 intervention cohort ratio) study was conducted in an 850-bed Victorian public metropolitan health service, Australia, from May to November 2017. Admitted acute care patients with a non-surgical condition, identified as at-risk of hospital readmission using an Electronic Health Record-derived readmission risk algorithm provide by the state health department, were eligible. Targeted Care Navigation involved telephone follow-up support provided for 30 days post-discharge by a registered nurse. The hazard ratio for hospital readmission was calculated at 30, 60 and 90 days post-discharge using multivariable Cox Proportional Hazards regression. RESULTS: Sixty-five recipients received care navigation and were matched to 262 people who did not receive care navigation. Excellent matching was achieved with standardised differences between groups being <0.1 for all 11 variables included in the propensity score, including the readmission risk score. The Targeted Care Navigation group had a significantly reduced hazard of readmission at 30 days (hazard ratio 0.34; 95% confidence interval: 0.12, 0.94) compared with the comparison group. The effect size was reduced at 60 and 90 days post-discharge. CONCLUSION: We provide preliminary evidence that Targeted Care Navigation supported by an Electronic Health Record-derived readmission risk algorithm may reduce 30-day hospital readmissions.

Effects of physical activity as an adjunct treatment on healing outcomes and recurrence of venous leg ulcers: A scoping review.

Healing time is protracted and ulcer recurrence is common in patients with venous leg ulcers. Although compression is the mainstay treatment, many patients do not heal timely. Physical activity may be a clinically effective adjunct treatment to compression to improve healing outcomes. This scoping review provides a broad overview of the effect of physical activity as an adjunct treatment to compression on wound healing and recurrence. We followed the six-step framework developed by Arksey and O'Malley. We searched electronic databases and trial registration websites for relevant studies and ongoing trials. Two authors independently screened and selected articles. Findings were presented in a descriptive statistical narrative summary. We consulted and presented our findings to the wound consumer group to ensure the relevance of our study. Physical activity interventions in 12 out of the 16 eligible studies consisted of only one component, eight studies were resistance exercises, three studies reported ankle and/or foot range of motion exercises, and one study reported aerobic/walking exercises. The remaining four studies involved multicomponent exercise interventions. Resistance exercise combined with ankle and/or foot range of motion exercise minimised ulcer size on day 12 (intervention group: 4.55 ± 1.14 cm2 vs. control group: 7.43 ± 0.56 cm2 ) and improved calf muscle pump performance on day 8 (ejection fraction: 40%-65%; residual volume fraction: 56%-40%). We identified one study that reported ulcer recurrence rate with no clinical difference in the intervention group versus the control group (i.e., 12% in intervention vs. 5% in control). Our review identified that resistance exercise was the most common type of physical activity intervention trialled in the published literature. Resistance exercise combined with ankle and/or foot range of motion exercise appears to be effective adjunct treatments; however, the overall evidence is still relatively weak as most programmes had a short intervention period which limited clinical outcomes.

Investigating quality of life instrument measurement properties for adults with active venous leg ulcers: A systematic review.

The primary objective of this systematic review was to identify which quality of life instruments have been applied in published studies of patients with active venous leg ulcers. Our secondary objective was to map the measurement properties of each identified quality of life instrument and to inform future recommendations for clinical practice and research. We searched CINAHL, Ovid Medline, Ovid Emcare and ProQuest to identify studies published from 1 January 2000 to 31 July 2021. Eleven studies that utilised quality of life instruments in adults with active venous leg ulcers met the inclusion criteria. Thirteen quality of life instruments were identified as some studies utilised both generic and condition-specific quality of life instruments. Six out of nine (6/9) instruments were rated 'very good' of methodological quality on internal consistency; 1/7 studies rated 'adequate' on reliability; 2/4 rated 'adequate' on content validity; 3/6 studies rated 'adequate' on structural validity; 5/6 rated 'adequate' on hypotheses testing for construct and 2/6 studies rated 'adequate' on responsiveness. There is limited evidence of measurement properties of quality of life instruments for people with active venous leg ulcers. The Venous Leg Ulcer Quality of Life Questionnaire (VLU-QoL) could be provisionally recommended for use although from our review it is clear further studies to assess VLU-QoL measurement properties are needed to inform future recommendations for clinical practice and research.

Once daily 300 mg aspirin with compression versus compression alone in patients with chronic venous leg ulcers (ASPiVLU): A randomised, double-blinded, multicentre, placebo-controlled, clinical trial.

AIM: Venous leg ulcers are lower limb skin ulcers characterised by a cycle of healing and recurrence due to underlying chronic venous insufficiency. While compression improves healing outcomes, many ulcers do not heal. As a daily 300 mg oral dose of aspirin in conjunction with compression may improve healing outcomes, we investigated the effect of adjuvant aspirin on venous leg ulcer healing in participants already receiving compression. MATERIALS AND METHODS: We conducted a prospective, randomised, double-blinded, placebo-controlled, clinical trial (known as ASPiVLU). Participants were recruited from six wound clinics in Australia. We screened 844 participants. Community-dwelling adult participants identified at six hospital outpatient clinics and clinically diagnosed with a venous leg ulcer present for 6+ weeks were eligible between April 13, 2015 to June 30, 2018. We randomised 40 participants (n = 19 aspirin, n = 21 placebo) and evaluated against the primary outcome. There were no dropouts. Ten serious adverse events in six participants were recorded. None were study related. The primary outcome measure was healing at 12 weeks based on blinded assessment. RESULTS: We found no difference in the number of ulcers healed at 12 weeks between the intervention and control groups. CONCLUSION: This study could not detect whether or not aspirin affected VLU healing speed. This is likely because we recruited fewer participants than expected due to the high number of people with venous leg ulcers in Australia who were already taking Aspirin; future research should investigate other adjuvant therapies or different study designs.

Effectiveness of ultrasonic debridement on reduction of bacteria and biofilm in patients with chronic wounds: A scoping review.

Chronic wounds are defined as "hard-to-heal" wounds that are caused by disordered mechanisms of wound healing. Chronic wounds have a high risk of infection and can form biofilms, leading to the release of planktonic bacteria, which causes persistent infections locally or remotely. Therefore, infection control and removal of the biofilm in chronic wounds are essential. Recently, ultrasonic debridement was introduced as a new method to reduce infection and promote the healing of chronic wounds. This scoping review aimed to evaluate the effectiveness of ultrasonic debridement on the changes in bacteria and biofilms, and consequently the wound healing rate of chronic wounds. A total of 1021 articles were identified through the database search, and nine papers were eligible for inclusion. Findings suggest that non-contact devices are useful for wound healing as they reduce the inflammatory response, although the bacterial load is not significantly changed. Ultrasonic debridement devices that require direct contact with the wound promote wound healing through reduction of biofilm or bacterial load. The optimum settings for ultrasonic debridement using a non-contact device are relatively consistent, but the settings for devices that require direct contact are diverse. Further studies on ultrasonic debridement in chronic wounds are required.

Management of people with venous leg ulcers by Australian general practitioners: An analysis of the national patient-encounter data.

Venous Leg Ulcers cost Australia's healthcare system millions yearly, as they are underdiagnosed, and possibly undertreated. Most Venous Leg Ulcers are seen in general practice. However, it is currently unknown as to what treatment actions are most common in these contexts. Understanding how they are managed in these settings can improve healthcare delivery and patient outcomes. Using cross-sectional general practitioner patient encounter data collected April 2006 to March 2016 from the Bettering the Evaluation and Care of Health program, a continuous national study of general practice clinical activity in Australia, we aimed to describe the characteristics of venous leg ulcer management by general practitioners in Australia. Among the 972 100 general practitioner-patient encounters recorded, 3604 (0.34%) involved management of VLU. Male general practitioners managed Venous Leg Ulcers significantly more often than female general practitioners. Most Venous Leg Ulcers were treated via dressings (76%) and/or pharmacological treatments (25.7%), with few patients receiving the best practice treatment of medical compression (2.1%) or referral (4.9%). Patients with new (first visit) Venous Leg Ulcers were more likely to receive pharmacological treatments and to be referred elsewhere, and less likely to receive dressings than patients receiving follow-up care. There appears to be a large gap between best practice guidelines and actual Venous Leg Ulcers treatments, as referrals and appropriate treatment was low. Further longitudinal studies are needed to determine the effectiveness of care for people with Venous Leg Ulcers who are managed by general practitioners.

Associations between patient, treatment, or wound-level factors and venous leg ulcer healing: Wound characteristics are the key factors in determining healing outcomes.

Chronic venous leg ulcers are challenging to heal and often recur. This has a significant impact on older individual health and is a financial burden on health care resources. This study aimed to identify factors associated with the healing of venous leg ulcers via secondary examination of data from a previously published prospective randomized controlled trial of elastic and inelastic compression systems. The data from the 45 patients who finished the trial was reanalyzed for a hypothesis generating study. Larger ulcers, higher exudate levels, larger calf circumferences, and longer ulcer duration at baseline were associated with lack of healing at 12 weeks. There was some evidence that NSAID use was associated with an increased likelihood of nonhealing (unadjusted OR for healing, 0.13, 95% CI (0.02, 0.70)). There was no evidence that other variables, including gender and BMI, were associated with healing. The key risk factors for wound healing are largely wound based or inherent to wound development, as these were found to be the factors with the strongest associations in the analysis. Future research should address how and why these factors are associated with wound healing over a longer time frame and explore how NSAIDs may affect wound healing outcomes.

The lived experience of recurrence prevention in patients with venous leg ulcers: An interpretative phenomenological study.

AIM OF THE STUDY: To explore patient understanding of why they develop a venous leg ulcer and how they can prevent recurrence. METHOD: The methodological framework of the hermeneutic phenomenological approach was used. Semi-structured interviews were conducted with seventeen participants living with a venous leg ulcer from May 2017 to November 2018. Data were analysed using Smith's interpretative hermeneutic analysis. RESULTS: The results are categorised into three main themes: "Trauma due to accident" (initial venous leg ulcer) and "Prevention of ulcer recurrence" (compression); "Trauma due to compression therapy" (venous leg ulcer recurrence). The findings demonstrate active venous leg ulcers are often caused by acute incidents while carrying out an activity in people with underlying chronic venous insufficiency. After a complete healing, preventive measures, such a compression stockings are initiated by the patient or health care provider. Trauma due to adherence to compression stockings caused skin breakdown beneath compression that caused subsequent ulcer recurrence. CONCLUSION: This study contributes to understanding the lived experience of patients with venous leg ulcers who develop a venous leg ulcer and their understanding of how they can prevent recurrence. Patients with VLUs would benefit from early preventive strategies, such as such a compression stockings fitting and application, integrated into daily care plan of primary care and community settings.

Understanding factors influencing venous leg ulcer guideline implementation in Australian primary care.

The aim of this study was to gain a better understanding of the venous leg ulcer (VLU) management in primary health care settings located in Melbourne metropolitan and rural Victoria, Australia. We explored health professionals' perspective on the use of the Australian and New Zealand Venous Leg Ulcer Clinical Practice Guideline (VLU CPG) to identify the main challenges of VLU CPG uptake in clinical practice. We conducted semi-structured interviews with 15 general practitioners (GPs) and 20 practice nurses (PNs), including two Aboriginal health nurses. The Theoretical Domains Framework guided data collection and analysis. Data were analysed using a theory-driven analysis. We found a lack of awareness of the VLU CPGs, which resulted in suboptimal knowledge and limited adherence to evidence-based recommendations. Environmental factors, such as busy nature of clinical environment and absence of handheld Doppler ultrasound, as well as social and professional identity factors, such as reliance on previous experience and colleague's advice, influenced the uptake of the VLU CPGs in primary care. Findings of this study will inform development of interventions to increase the uptake of the VLU CPG in primary care settings and to reduce the evidence-practice gap in VLU management by health professionals.

Rationale for participation in venous leg ulcer clinical research: Patient interview study.

Recruitment to wound care clinical trials is challenging and a better understanding of patient decisions to participate has the potential to influence recruitment success. We conducted 31 semi-structured telephone interviews of patients who participated in the Aspirin in Venous Leg Ulcer (ASPiVLU) randomised controlled trail (RCT) or ASPiVLU cohort study. Data were coded and analysed using thematic analysis. We identified four key themes: (a) "I participated to help others"; (b) "I participated in research to thank those who cared for me"; (c) "I participated to receive better care"; and (d) "I participated to have a say on what works." These themes became basic elements for the Rationale for Research Participation Framework that we have developed to improve the participant recruitment process for clinical trials in wound care.

Patient education materials on pressure injury prevention in hospitals and health services in Victoria, Australia: Availability and content analysis.

Pressure injuries (PIs) are a common quality indicator for hospital care, and preventing PIs often requires patient engagement; as such, Australian consensus research has recommended that high-quality education materials be made to patients for PIs via hospital networks. The purpose of the present study was to assess the availability and accuracy of patient education materials on PIs in publicly available hospital websites in Victoria, Australia. Two independent coders assessed 212 websites for content on PI prevention and management, analysing availability and accuracy of PI definitions, risk factors, preventive strategies, referral, visual tools, consumer endorsement, information for family/carers, and translation on community languages. A greater proportion of hospitals did not have any patient education materials on PI prevention publicly available, with private hospitals (compared with public) and metropolitan hospitals (compared to rural) more likely to have materials available on their sites. The available materials contained accurate messages on PI defining characteristics and risk factors for PIs, although there was considerable variability on the availability of other information. Our findings suggest a significant deficit in the availability of educational materials for acute care patients and their families. There is a need for evidence-based, consumer-endorsed, uniform materials on all hospital websites to prevent PIs in acute care.

Pressure injury data in Australian acute care settings: A comparison of three data sets.

Hospital-acquired pressure injuries (HAPIs) represent a serious clinical and economic problem. The cost of treating HAPIs in Australian public hospitals was recently reported at AUS$983 million per annum. There are three main sources of data for documenting pressure injury (PI) occurrence in Australian hospitals: incident reporting, medical record coded data, and real-time surveys of pressure injury. PI data reported at hospital level and to external agencies using these three different sources are variable. This reporting issue leads to inaccurate data interpretation and hinders improvement in accuracy of PI identification and PI prevention. This study involved a comparison of the three different data sources in selected Australian hospitals, to improve the accuracy and comparability of data. Findings from this study provide benchmark areas for improvement in PI documenting and reporting. Better understanding the agreement between the three data sets could lead to a more efficient and effective sharing of data sources.

Adjuvant therapies in venous leg ulcer management: A scoping review.

Compression therapy is the current evidence-based approach to manage venous leg ulcers (VLU); however, adherence is a major barrier to successful treatment. Combination approaches may relieve the burden of treatment by shortening the time to ulcer healing. This scoping review conducted by Australian researchers aimed to establish the evidence of effectiveness of various adjuvant methods on wound healing and recurrence. Randomized Controlled Trials (RCTs), and Systematic Reviews (SR) and Meta-Analyses (MA) on VLU management approaches published from January 2015 to December 2018 were included in this review. The articles included in the scoping review were grouped according to the management approaches, including (1) pharmaceutical interventions, (2) surgical interventions, (3) topical agents, (4) the use of devices, and (5) other, such as physiotherapy and psychological interventions. Results of this scoping review indicate that there is a limited high-quality evidence of effectiveness in most adjuvant therapies on wound healing and recurrence. Given the low-quality evidence observed in this scoping review for adjuvant treatments, the implication for practice is that current management guidelines be followed. Further rigorous studies have the potential to produce better quality evidence. Quality of evidence can be improved by ensuring large sample sizes of a single etiology wounds, standardizing reporting outcomes, and maintaining detailed and evidence-based protocols in physiological or psychological interventions.

External validity of randomized controlled trials of interventions in venous leg ulceration: A systematic review.

We set out to evaluate quality of reporting of data related to external validity from randomized controlled trials (RCTs) assessing treatment interventions for active venous leg ulcers. Using a systematic review study design, we identified 144 full-text RCTs of treatment interventions, where the wound was assessed and published in English from 1998 to 2018. We found that the median study sample size was 75.5. Weighted mean wound size was 13.22 cm2 and weighted mean wound duration was 22.20 months. Forty-six (32%) reported numbers screened for eligibility and 27 (19%) reported the number who declined to participate; 19 (13%) reported on patient ethnicity; 60 (42%) reported comorbidities; and 5 (4%) reported current medication use. When reported, 60/102 (59%) excluded patients with an ankle-brachial pressure index <0.8; 68/135 (50%) were conducted in Europe, 6/135 (4%) in Asia, and 74/104 (71%) were conducted in outpatient facilities; 3 (2%) reported socioeconomic factors and 88 (61%) reported on adverse events. We concluded that there is inadequate reporting of data related to external validity in reports of RCTs assessing venous leg ulcers treatment interventions. Significant variability exists in the ankle-brachial pressure index cutoff point for inclusion or exclusion, making generalizability difficult to assess.

Subfascial endoscopic perforator surgery (SEPS) for treating venous leg ulcers.

BACKGROUND: Venous leg ulcers are complex, costly, and their prevalence is expected to increase as populations age. Venous congestion is a possible cause of venous leg ulcers, which subfascial endoscopic perforator surgery (SEPS) attempts to address by removing the connection between deep and superficial veins (perforator veins). The effectiveness of SEPS in the treatment of venous leg ulcers, however, is unclear. OBJECTIVES: To assess the benefits and harms of subfascial endoscopic perforator surgery (SEPS) for the treatment of venous leg ulcers. SEARCH METHODS: In March 2018 we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including In-Process & Other Non-Indexed Citations); Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and scanned reference lists of included studies as well as reviews, meta-analyses and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication or study setting. SELECTION CRITERIA: We included randomised controlled trials (RCTs) of interventions that examined the use of SEPS independently or in combination with another intervention for the treatment of venous leg ulcers. DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies for inclusion, extracted data, assessed risk of bias, and assessed the certainty of evidence using the GRADE approach. MAIN RESULTS: We included four RCTs with a total of 322 participants. There were three different comparators: SEPS plus compression therapy versus compression therapy (two trials); SEPS versus the Linton procedure (a type of open surgery) (one trial); and SEPS plus saphenous surgery versus saphenous surgery (one trial). The age range of participants was 30 to 82, with an equal spread of male and female participants. All trials were conducted in hospital settings with varying durations of follow-up, from 18 months to 6 years. One trial included participants who had both healed and active ulcers, with the rest including only participants with active ulcers.There was the potential for reporting bias in all trials and performance bias and detection bias in three trials. Participants in the fourth trial received one of two surgical procedures, and this study was at low risk of performance bias and detection bias.SEPS + compression therapy versus compression therapy (2 studies; 208 participants)There may be an increase in the proportion of healed ulcers at 24 months in people treated with SEPS and compression therapy compared with compression therapy alone (risk ratio (RR) 1.17, 95% confidence interval (CI) 1.03 to 1.33; 1 study; 196 participants); low-certainty evidence (downgraded twice, once for risk of bias and once for imprecision).It is uncertain whether SEPS reduces the risk of ulcer recurrence at 24 months (RR 0.85, 95% CI 0.26 to 2.76; 2 studies; 208 participants); very low-certainty evidence (downgraded three times, twice for very serious imprecision and once for risk of bias).The included trials did not measure or report the following outcomes; time to complete healing, health-related quality of life (HRQOL), adverse events, pain, duration of hospitalisation, and district nursing care requirements.SEPS versus Linton approach (1 study; 39 participants)It is uncertain whether there is a difference in ulcer healing at 24 months between participants treated with SEPS and those treated with the Linton procedure (RR 0.95, 95% CI 0.83 to 1.09; 1 study; 39 participants); very low-certainty evidence (downgraded three times, twice for very serious imprecision and once for risk of bias).It is also uncertain whether there is a difference in risk of recurrence at 60 months: (RR 0.47, 95% CI 0.10 to 2.30; 1 study; 39 participants); very low-certainty evidence (downgraded three times, twice for very serious imprecision and once for risk of bias).The Linton procedure is possibly associated with more adverse events than SEPS (RR 0.04, 95% CI 0.00 to 0.60; 1 study; 39 participants); very low-certainty evidence (downgraded three times, twice for very serious imprecision and once for risk of bias).The outcomes time to complete healing, HRQOL, pain, duration of hospitalisation and district nursing care requirements were either not measured, reported or data were not available for analysis.SEPS + saphenous surgery versus saphenous surgery (1 study; 75 participants)It is uncertain whether there is a difference in ulcer healing at 12 months between participants treated with SEPS and saphenous surgery versus those treated with saphenous surgery alone (RR 0.96, 95% CI 0.64 to 1.43; 1 study; 22 participants); very low certainty evidence (downgraded three times, twice for very serious imprecision and once for high risk of reporting bias).It is also uncertain whether there is a difference in the risk of recurrence at 12 months: (RR 1.03, 95% CI 0.15 to 6.91; 1 study; 75 participants); very low certainty evidence (downgraded three times, twice for very serious imprecision and once for high risk of reporting bias).Finally, we are uncertain whether there is an increase in adverse events in the SEPS group (RR 2.05, 95% CI 0.86 to 4.90; 1 study; 75 participants); very low certainty evidence (downgraded three times, twice for very serious imprecision and once for high risk of reporting bias).The outcomes time to complete healing, HRQOL, serious adverse events, pain, duration of hospitalisation, and district nursing care requirements were either not measured, reported or data were not available for analysis. AUTHORS' CONCLUSIONS: The role of SEPS for the treatment of venous leg ulcers remains uncertain. Only low or very low-certainty evidence was available for inclusion. Due to small sample sizes and risk of bias in the included studies, we were unable to determine the potential benefits and harms of SEPS for this purpose. Only four studies met our inclusion criteria, three were very small, and one was poorly reported. Further high-quality studies addressing the use of SEPS in venous leg ulcer management are likely to change the conclusions of this review.

Randomised controlled trials as part of clinical care: A seven-step routinisation framework proposal.

Evidence translation in wound care relies on the need for evidence generation. Clinical practice may generate evidence only if evidence-generating research projects, such as randomised controlled trials (RCTs), became routinised in clinical settings. The aim of this study was to identify optimal trial-related practices to routinise trial-related activities in Melbourne-located wound clinics as reported by clinicians and researchers. We conducted a secondary analysis of the available data on how to routinise RCTs in clinical care, with a focus on enablers and suggestions provided by the participants during face-to-face and telephone interviews. Data were obtained from a qualitative observational study nested within a randomised, double-blinded, placebo-controlled trial on clinical effectiveness of aspirin as an adjunct to compression therapy in healing chronic venous leg ulcers (ASPiVLU). We developed a seven-step Routinisation of Trials in Clinical Care Framework. These steps include: (1) pre-trial clinical site assessment, (2) optimising pre-recruitment arrangements, (3) developing and updating trial-related skills, (4) embedding RCT recruitment as part of routine clinical care, (5) promoting teamwork and trial-related collaboration, (6) addressing trial-related financial issues, and (7) communicating trial results to clinicians.

Autologous platelet-rich plasma for healing chronic venous leg ulcers: Clinical efficacy and potential mechanisms.

The overall quality of evidence of autologous platelet-rich plasma (PRP) for treating chronic wounds remains low. While further well-designed clinical studies are clearly required to convincingly demonstrate the efficacy of autologous PRP in improved healing of venous leg ulcers (VLUs) and other chronic wounds, there is also an increasing need to better define the underlying mechanisms of action and whether positive outcomes can be predicted based on the analysis of PRP. This brief review will discuss the current understanding of autologous PRP in VLUs and whether molecular evaluation of PRP at the time of collection could potentially be informative to clinical outcomes. Benefits of the autologous PRP treatment strategy include that PRP is easily accessible and is relatively inexpensive and safe. Better understanding of the mechanisms involved could improve treatment, enable supplementation, and/or lead to gains in product development. Analysis of PRP could also add value to future clinical trials on efficacy and potentially personalised treatment regimens.

ABPI reporting and compression recommendations in global clinical practice guidelines on venous leg ulcer management: A scoping review.

Clinical practice guidelines (CPGs) for venous leg ulcer (VLU) management recommend below-knee compression to improve healing outcomes after calculating the ankle-brachial pressure index (ABPI) to rule out significant arterial disease. This systematic scoping review aimed to complete a qualitative and quantitative content analysis of international CPGs for VLU management to determine if consensus existed in relation to recommendations for compression application based on an ABPI reading and clinical assessment. Our review shows that there is a lack of consensus across 13 VLU CPGs and a lack of clear guidance in relation to the specific ABPI range of compression therapy that can be safely applied. An area of uncertainty and disagreement exists in relation to an ABPI between 0.6 and 0.8, with some guidelines advocating that compression is contraindicated and others that there should be reduced compression. This has implications in clinical practice, including when it is safe to apply compression. In addition, the inconsistency in the levels of evidence and the grades of recommendation makes it difficult to compare across various guidelines.