Eliminating Hospital-Acquired Pressure Injuries Caused by Graduated Compression Stockings.

PURPOSE: The purpose of this evidence-based practice project was to reduce the incidence of pressure injuries (PIs) from the use of graduated compression stockings in patients on a gastrointestinal (GI) sarcoma surgery unit. Before this project, the standard of care for preventing deep vein thrombosis (DVT) included the use of graduated compression stockings, anticoagulation therapy, and intermittent pneumatic compression devices. We sought to examine the impact on PI and DVT risk of using only anticoagulation therapy and intermittent pneumatic compression devices. METHODS: The pilot phase of the project began in June 2017 when nurses on the GI sarcoma surgery unit initiated a practice change in which graduated compression stockings were removed during the 7 AM shift change and put back on the patient before bedtime. Data on the incidence of DVTs and PIs were already being collected in our institution's electronic health record and safety intelligence reporting system. The project team monitored the incidence of PIs and DVTs throughout the project. After the pilot project concluded in August 2017, the GI sarcoma surgery unit staff continued the practice of taking off graduated compression stockings during the day, until on June 2018 the use of graduated compression stockings was formally discontinued for all surgical patients, both during the day and night. RESULTS: Data collected during the pilot phase revealed that no PIs or DVTs occurred among the 497 study patients on the GI sarcoma surgery unit. From June to October 2017, the unit cared for a total of 856 patients and PI and DVT rates remained at zero. From the start of the pilot project in June 2017 to October 2018 (five months after the discontinuation of graduated compression stockings on all surgical units) the unit cared for 3,141 patients-an average of 174 patients per month-and had a zero rate of PIs and DVTs. CONCLUSIONS: We found that the use of graduated compression stockings confers more risks than benefits for patients. Our findings prompted the discontinuation of graduated compression stockings use in postoperative patients throughout our institution. In the 17 months after the pilot project was initiated, no PIs occurred among patients in the GI sarcoma surgery unit, which also maintained a zero rate of DVTs.

Prophylaxis of venous thromboembolism in general surgery in Spain. Analysis of a national survey. / Profilaxis del tromboembolismo venoso en cirugía general en España. Análisis de una encuesta nacional.

INTRODUCTION: Venous thromboembolism (VTE) represents a serious postoperative complication that can be prevented by adequate thromboprophylaxis. Surveys provide relevant information about clinician's attitudes and preferences regarding VTE prophylaxis. METHODS: Transversal, descriptive study based on a survey sent to general surgeons members of the Spanish Association of Surgeons (AEC), that included 31 questions regarding postoperative VTE and its prevention, as well as three clinical scenarios. RESULTS: 530 surgeons, 21.8% of the 2,429 invited by electronic mail to participate, completed the survey. Most of the answering clinicians work on in big teaching hospitals, and 28.5% are residents. VTE represents a serious problem for 28% of participants. Although 81% consider that their knowledge on the prevention of postoperative VTE is adequate, a similar percentage recognizes the need for further education. The vast majority (98.7%) use low molecular weight heparins, which are considered the most effective and safe modality, followed by mechanical methods. The Caprini risk assessment score is used by 81% of surgeons, who usually start pharmacological prophylaxis preoperatively. However, there are remarkable differences in the dosing of heparins, timing of initiation, and duration, especially in non-oncologic surgical patients. CONCLUSIONS: Most Spanish surgeons are interested in the prevention of postoperative VTE. Overall, the level of knowledge on thromboprophylaxis is adequate. However, our results indicate that there is a need for better education on relevant practical aspects of prophylaxis that could be achieved by incorporating recommendations from recent guidelines to local hospital-based protocols.

Treatment of chronic venous insufficiency in Latin America.

OBJECTIVE: Venous disease is common in Latin America, with an estimated 68.11% prevalence of chronic venous disease. The diverse social, political, and economic characteristics of the many nations that make up Latin America mean that different conditions affect how these diseases are diagnosed and treated, which may differ markedly from the way they are treated by the health care systems of the United States and Europe. Our goal was to review the current state of treatment of chronic venous insufficiency (CVI) in Latin America. METHODS: This is a narrative review of the medical literature on the subject and synthesizes sometimes fragmentary information on CVI across a large and diverse region. RESULTS: CVI represents an unmet medical need in Latin America. Conservative treatments, such as compression stockings, may be used at first, and there are nonpharmacologic and complementary and alternative medicine approaches in use. Endovenous approaches, such as endovenous thermal ablation, have largely replaced surgical interventions. In Europe and the United States, such procedures are mainly carried out in ambulatory facilities, whereas they are mainly performed in the hospital in Latin America. CONCLUSIONS: Recent strong economic growth in Latin America and improvements in social security and health care suggest that innovative approaches to chronic venous disease and CVI will be implemented.

Round-knit or flat-knit compression garments for maintenance therapy of lymphedema of the leg? - Review of the literature and technical data.

To date, there have been no studies comparing flat-knit and round-knit compression garments for maintenance therapy of lymphedema of the leg. According to expert opinion, flat-knit fabrics are generally recommended for this purpose. Given the differences in the clinical presentation of lymphedema in terms of disease stage and location as well as patient adherence, and, last but not least, for economic reasons, it seems questionable whether all patients with lymphedema of the leg actually do require flat-knit compression garments. Considering technical aspects, published data and our own clinical experience, it seems reasonable that the choice of compression stockings be based on clinical findings and not on the diagnosis. Typical indications for flat-knit garments include significant differences in leg circumference as well as deep skin folds and edema of the toes/forefoot. However, there are also patients with lymphedema who benefit from round-knit fabrics with a high degree of stiffness. In any case, prior to maintenance therapy, it is essential to adequately decongest the legs using compression bandages and/or adaptive compression systems.

Graduated compression stockings for the prevention of deep-vein thrombosis in postoperative surgical patients: a systematic review and economic model with a value of information analysis.

BACKGROUND: Deep-vein thrombosis (DVT) can occur in surgical patients. Routine prophylaxis can be pharmacological and/or mechanical [e.g. graduated compression stockings (GCSs)]. GCSs are available in knee length or thigh length. OBJECTIVE: To establish the expected value of undertaking additional research addressing the relative effectiveness of thigh-length GCSs versus knee-length GCSs, in addition to pharmacoprophylaxis, for prevention of DVT in surgical patients. DESIGN: Systematic review and economic model, including value of information (VOI) analysis. REVIEW METHODS: Randomised controlled trials (RCTs) assessing thigh- or knee-length GCSs in surgical patients were eligible for inclusion. The primary outcome was incidence of DVT. DVT complications and GCSs adverse events were assessed. Random-effects meta-analysis was performed. To draw on a wider evidence base, a random-effects network meta-analysis (NMA) was undertaken for the outcome DVT. A review of trials and observational studies of patient adherence was also conducted. A decision-analytic model was developed to assess the cost-effectiveness of thigh- and knee-length GCSs and the VOI. RESULTS: Twenty-three RCTs were included in the review of effectiveness. There was substantial variation between trials in terms of the patient characteristics, interventions and methods of outcome assessment. Five trials comparing knee-length with thigh-length GCSs with or without pharmacoprophylaxis were pooled; the summary estimate of effect indicated a non-significant trend favouring thigh-length GCSs [odds ratio (OR) 1.48, 95% confidence interval (CI) 0.80 to 2.73]. Thirteen trials were included in the NMA. In the base-case analysis, thigh-length GCSs with pharmacoprophylaxis were more effective than knee-length GCSs with pharmacoprophylaxis (knee vs. thigh OR 1.76, 95% credible interval 0.82 to 3.53). Overall, thigh-length stockings with pharmacoprophylaxis was the most effective treatment, with a 0.73 probability of being the most effective treatment in a new trial of all the treatments. Patient adherence was generally higher with knee-length GCSs, and patients preferred knee-length GCSs. Thigh-length GCSs were found to be cost-effective in all but the subgroup with the lowest baseline risk, although the absolute differences in costs and effects were relatively small. The expected value of perfect information ranged from £0.2M to £178.0M depending on the scenario and subgroup. The relative effect parameters had the highest expected value of partial perfect information and ranged from £2.0M to £39.4M. The value of further research was most evident in the high-risk subgroups. LIMITATIONS: There was substantial variation across the included trials in terms of patient and intervention characteristics. Many of the included trials were old and poorly reported, which reduces the reliability of the results of the review. CONCLUSIONS: Given that the results from both the standard meta-analysis and the NMA lacked precision (CIs were wide) owing to the heterogeneous evidence base, a new definitive trial in high-risk patients may be warranted. However, the efficiency of any further research (i.e. whether this represents value for money) is dependent on several factors, including the acquisition price of GCSs, expected compliance with thigh-length GCSs wear, and whether or not uncertainty can be resolved around possible effect modifiers, as well as the feasibility and actual cost of undertaking the proposed research. STUDY REGISTRATION: This study is registered as PROSPERO CRD42014007202. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

A Cost-effectiveness Analysis of Surgery, Endothermal Ablation, Ultrasound-guided Foam Sclerotherapy and Compression Stockings for Symptomatic Varicose Veins.

OBJECTIVE: The aim was to investigate the cost-effectiveness of interventional treatment for varicose veins (VV) in the UK NHS, and to inform the national clinical guideline on VV, published by the National Institute of Health and Care Excellence. DESIGN: An economic analysis was constructed to compare the cost-effectiveness of surgery, endothermal ablation (ETA), ultrasound-guided foam sclerotherapy (UGFS), and compression stockings (CS). The analysis was based on a Markov decision model, which was developed in consultation with members of the NICE guideline development group (GDG). METHODS: The model had a 5-year time horizon, and took the perspective of the UK National Health Service. Clinical inputs were based on a network meta-analysis (NMA), informed by a systematic review of the clinical literature. Outcomes were expressed as costs and quality-adjusted life years (QALYs). RESULTS: All interventional treatments were found to be cost-effective compared with CS at a cost-effectiveness threshold of £20,000 per QALY gained. ETA was found to be the most cost-effective strategy overall, with an incremental cost-effectiveness ratio of £3,161 per QALY gained compared with UGFS. Surgery and CS were dominated by ETA. CONCLUSIONS: Interventional treatment for VV is cost-effective in the UK NHS. Specifically, based on current data, ETA is the most cost-effective treatment in people for whom it is suitable. The results of this research were used to inform recommendations within the NICE guideline on VV.

VenUS IV (Venous leg Ulcer Study IV) - compression hosiery compared with compression bandaging in the treatment of venous leg ulcers: a randomised controlled trial, mixed-treatment comparison and decision-analytic model.

BACKGROUND: Compression is an effective and recommended treatment for venous leg ulcers. Although the four-layer bandage (4LB) is regarded as the gold standard compression system, it is recognised that the amount of compression delivered might be compromised by poor application technique. Also the bulky nature of the bandages might reduce ankle or leg mobility and make the wearing of shoes difficult. Two-layer compression hosiery systems are now available for the treatment of venous leg ulcers. Two-layer hosiery (HH) may be advantageous, as it has reduced bulk, which might enhance ankle or leg mobility and patient adherence. Some patients can also remove and reapply two-layer hosiery, which may encourage self-management and could reduce costs. However, little robust evidence exists about the effectiveness of two-layer hosiery for ulcer healing and no previous trials have compared two-layer hosiery delivering 'high' compression with the 4LB. OBJECTIVES: Part I To compare the clinical effectiveness and cost-effectiveness of HH and 4LB in terms of time to complete healing of venous leg ulcers. Part II To synthesise the relative effectiveness evidence (for ulcer healing) of high-compression treatments for venous leg ulcers using a mixed-treatment comparison (MTC). Part III To construct a decision-analytic model to assess the cost-effectiveness of high-compression treatments for venous leg ulcers. DESIGN: Part I A multicentred, pragmatic, two-arm, parallel, open randomised controlled trial (RCT) with an economic evaluation. Part II MTC using all relevant RCT data - including Venous leg Ulcer Study IV (VenUS IV). Part III A decision-analytic Markov model. SETTINGS: Part I Community nurse teams or services, general practitioner practices, leg ulcer clinics, tissue viability clinics or services and wound clinics within England and Northern Ireland. PARTICIPANTS: Part I Patients aged ≥ 18 years with a venous leg ulcer, who were willing and able to tolerate high compression. INTERVENTIONS: Part I Participants in the intervention group received HH. The control group received the 4LB, which was applied according to standard practice. Both treatments are designed to deliver 40 mmHg of compression at the ankle. Part II and III All relevant high-compression treatments including HH, the 4LB and the two-layer bandage (2LB). MAIN OUTCOME MEASURES: Part I The primary outcome measure was time to healing of the reference ulcer (blinded assessment). Part II Time to ulcer healing. Part III Quality-adjusted life-years (QALYs) and costs. RESULTS: Part I A total of 457 participants were recruited. There was no evidence of a difference in time to healing of the reference ulcer between groups in an adjusted analysis [hazard ratio (HR) 0.99, 95% confidence interval (CI) 0.79 to 1.25; p = 0.96]. Time to ulcer recurrence was significantly shorter in the 4LB group (HR = 0.56, 95% CI 0.33 to 0.94; p = 0.026). In terms of cost-effectiveness, using QALYs as the measure of benefit, HH had a > 95% probability of being the most cost-effective treatment based on the within-trial analysis. Part II The MTC suggests that the 2LB has the highest probability of ulcer healing compared with other high-compression treatments. However, this evidence is categorised as low to very low quality. Part III Results suggested that the 2LB had the highest probability of being the most cost-effective high-compression treatment for venous leg ulcers. CONCLUSIONS: Trial data from VenUS IV found no evidence of a difference in venous ulcer healing between HH and the 4LB. HH may reduce ulcer recurrence rates compared with the 4LB and be a cost-effective treatment. When all available high-compression treatments were considered, the 2LB had the highest probability of being clinically effective and cost-effective. However, the underpinning evidence was sparse and more research is needed. Further research should thus focus on establishing, in a high-quality trial, the effectiveness of this compression system in particular. TRIAL REGISTRATION: Current Controlled Trials ISRCTN49373072. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 18, No. 57. See the NIHR Journals Library website for further project information.

Clinical and cost-effectiveness of compression hosiery versus compression bandages in treatment of venous leg ulcers (Venous leg Ulcer Study IV, VenUS IV): a randomised controlled trial.

BACKGROUND: Drawbacks exist with the standard treatment (four-layer compression bandages) for venous leg ulcers. We have therefore compared the clinical effectiveness and cost-effectiveness of two-layer compression hosiery with the four-layer bandage for the treatment of such ulcers. METHODS: We undertook this pragmatic, open, randomised controlled trial with two parallel groups in 34 centres in England and Northern Ireland. The centres were community nurse teams or services, family doctor practices, leg ulcer clinics, tissue viability clinics or services, and wound clinics. Participants were aged 18 years or older with a venous leg ulcer and an ankle brachial pressure index of at least 0·8, and were tolerant of high compression. We randomly allocated participants (1:1) to receive two-layer compression hosiery or a four-layer bandage, using a remote randomisation service and prevalidated computer randomisation program. Participants were stratified by ulcer duration and ulcer area with permuted blocks (block sizes four and six). The primary endpoint was time to ulcer healing, with a maximum follow-up of 12 months. Although participants and health-care providers were not masked to treatment allocation, the primary endpoint was measured by masked assessment of photographs. Primary analysis was intention to treat with Cox regression, with adjustment for ulcer area, ulcer duration, physical mobility, and centre. This trial is registered with the ISRCTN register, number ISRCTN49373072. FINDINGS: We randomly allocated 457 participants to the two treatment groups: 230 to two-layer hosiery and 227 to the four-layer bandage, of whom 453 (230 hosiery and 223 bandage) contributed data for analysis. Median time to ulcer healing was 99 days (95% CI 84-126) in the hosiery group and 98 days (85-112) in the bandage group, and the proportion of ulcers healing was much the same in the two groups (70·9% hosiery and 70·4% bandage). More hosiery participants changed their allocated treatment (38·3% hosiery vs 27·0% bandage; p=0·02). 300 participants had 895 adverse events, of which 85 (9·5%) were classed as serious but unrelated to trial treatment. INTERPRETATION: Two-layer compression hosiery is a viable alternative to the four-layer bandage-it is equally as effective at healing venous leg ulcers. However, a higher rate of treatment changes in participants in the hosiery group than in the bandage group suggests that hosiery might not be suitable for all patients. FUNDING: NIHR Health Technology Assessment programme (07/60/26).

Short-term gain for long-term pain? Which patients should be treated and should we ration?

OBJECTIVES: Treatments of common conditions which do not affect mortality often become sidelined in the drive to improve efficiency and reduce costs. The rationing of patients is a divisive but crucial component to universal health care. How should this be accomplished? METHODS AND RESULTS: In this article we examine the outcomes of various rationing methods in varicose veins. CONCLUSIONS: No method is perfect and treatment of symptoms and complications should remain the target for all physicians.

Randomized clinical trial of honey-impregnated dressings for venous leg ulcers.

BACKGROUND: The efficacy of honey as a treatment for venous ulcers has not been evaluated, despite widespread interest. This trial aimed to evaluate the safety and effectiveness of honey as a dressing for venous ulcers. METHODS: This community-based open-label randomized trial allocated people with a venous ulcer to calcium alginate dressings impregnated with manuka honey or usual care. All participants received compression bandaging. The primary outcome was the proportion of ulcers healed after 12 weeks. Secondary outcomes were: time to healing, change in ulcer area, incidence of infection, costs per healed ulcer, adverse events and quality of life. Analysis was by intention to treat. RESULTS: Of 368 participants, 187 were randomized to honey and 181 to usual care. At 12 weeks, 104 ulcers (55.6 per cent) in the honey-treated group and 90 (49.7 per cent) in the usual care group had healed (absolute increase 5.9 (95 per cent confidence interval (c.i.) -4.3 to 15.7) per cent; P = 0.258). Treatment with honey was probably more expensive and associated with more adverse events (relative risk 1.3 (95 per cent c.i. 1.1 to 1.6); P = 0.013). There were no significant differences between the groups for other outcomes. CONCLUSION: Honey-impregnated dressings did not significantly improve venous ulcer healing at 12 weeks compared with usual care. REGISTRATION NUMBER: ISRCTN 06161544 (http://www.controlled-trials.com).

The use of knee-length versus thigh-length compression stockings and sequential compression devices.

BACKGROUND: Nurses on an Acute Care Evidence Based Practice Committee, creating a policy to increase patient compliance with thromboembolic deterrent stockings (TEDS) and sequential compression devices (SCDs) for deep vein thrombosis prophylaxis, found limited literature on patient preference and response to this treatment. STUDY AIM: The study purpose was to determine whether knee-length or thigh-length TEDS and/or SCDs were more comfortable, correctly applied, and worn by patients, and to assess patient reasons for noncompliance. METHOD: A patient survey and observational data tool was designed. Six surveyors collected data (interrater reliability = 93%) from 137 randomly selected patients with orders for TEDS and/or SCDs admitted to acute care medical or surgical nursing units. RESULTS: Most patients wore thigh-length SCDs and TEDS. However, only 29.2% (n = 40) had SCDs on them at the time of survey, and 62.8% (n = 86) were compliant with TEDS. The most common reasons given for noncompliance with SCDs were that the devices were not reapplied after bathing or ambulating, or were removed because they were hot or itchy. Complaints of discomfort were highest among patients wearing thigh-length SCDs and TEDS. Problems with fit were 50% higher in those who wore thigh-length TEDS, and involved stockings that created restricting bands. Most patients understood the purpose of treatment, and older patients were more compliant than younger patients. IMPLICATIONS FOR PRACTICE: Knee-length TEDS and SCDs are more comfortable for patients, encourage higher levels of compliance with treatment, do not pose a risk for venous stasis to patients by creating restricting bands, and are less expensive. Patients need ongoing education to resume wearing TEDS and SCDs after activities of daily living, and knee-length stockings and devices would be easier to reapply. The policy in our institution was changed for the use of knee-length compression stockings and SCDs.

Experimental assessment and analytical 2D predictions of the stocking pressures induced on a model leg by Medical Compressive Stockings.

Stocking supports have represented, for more than two millennia, the most efficient way to treat the veinous diseases and lymphatic disorders. Although this treatment consists solely in the application of a mechanical pressure to help the blood in reaching back the heart, very little is known on this mechanical effort exerted on a human limb by knitted fabrics. However, nowadays the precise assessment of this pressure distribution is crucial in fitting the treatment to the patient pathology and morphology. In order to describe rationally, for the first time, the pressure distribution induced on a leg, a combined experiment-simulation 2D methodology has been set to validate this mechanical approach. The present article is the first part of a two-papers communication. Experimental aspects are presented here, first to measure these stocking pressures on a rigid leg using the SIGaT((R)) device based on a pneumatic sensor. Then, the knitted fabric mechanical response is characterized under uniaxial tension for large strains, to evaluate the simplified Laplace-based pressure that can be compared with the pressure measurements, knowing the local curvature radii of a leg section. This experimental approach is to be completed with numerical simulations of the stocking mechanism on the same model leg.