Implementing a Locally Made Low-Cost Intervention for Wound and Lymphedema Care in Western Kenya.

In Western Kenya, the burden of chronic wounds and lymphedema has a significant impact on functionality and quality of life. Major barriers to provision of care include availability, affordability, and accessibility of bandages. At the Academic Model Providing Access to Healthcare, dermatologists and pharmacists collaborated to develop a 2-component compression bandage modeled after the Unna boot, using locally available materials, that is distributed through a revolving fund pharmacy network. In partnership with nursing, use of these bandages at a national referral hospital and a few county facilities has increased, but increasing utilization to an expanded catchment area is needed.

Economic benefit of a novel dual-mode ambulatory compression device for treatment of chronic venous leg ulcers in a randomized clinical trial.

BACKGROUND: Limb compression is a key component of protocols used to heal venous leg ulcers (VLUs). A novel ambulatory pneumatic compression device was tested in comparison with multilayered bandage (MLB) compression systems for the treatment of VLUs in a prospective randomized clinical trial. METHODS: Patients with VLUs measuring 1.5 to 50 cm2 with duration of 1 to 24 months were randomized to treatment with a pneumatic compression device, the ACTitouch adaptive compression therapy (ACT) system (Tactile Medical, Minneapolis, Minn), or MLB. The ACT group patients were seen in the clinic at weeks 1, 2, 4, 6, 9, 12, and 16 or until wounds healed; the MLB group was seen weekly for bandage and dressing changes for 16 weeks or until wounds healed. All other aspects of VLU care were standardized between the two groups. The primary study objective was to compare the VLU percentage area reduction at 16 weeks in the ACT group compared with the MLB group. RESULTS: There were 56 patients randomized to treatment with ACT (n = 26) or MLB (n = 30). In the ACT group, five patients exited because of skin or wound problems related to the ACT device and five withdrew because of the inconvenience of using the device. Therefore, the trial was halted before full randomization so improvements to the ACT device could be made. Data collected on 42 patients who were able to tolerate treatment for the 16-week study period (per protocol group) showed that both groups experienced similar rates of wound healing. In the per protocol population, the percentage area size reduction was greater for the ACT group compared with the MLB group (83.8% vs 70.5%, respectively), whereas no significant differences were noted in the percentage of wounds that healed by 16 weeks (60.0% vs 63.0%, respectively). CONCLUSIONS: In this truncated clinical trial, a novel dual-mode ambulatory compression device, when tolerated, achieved wound healing results similar to those with MLB for chronic VLUs. The device requires modifications to improve the patient's comfort and ease of use. However, this mode of therapy appears to have promise for improving the cost-effectiveness of treatment for chronic VLUs.

Clinical and Economic Impact of a Two-layer Compression System for the Treatment of Venous Leg Ulcers: A Systematic Review.

OBJECTIVE: This study evaluates the clinical and cost effectiveness of a 2-layer compression system (2LBA; 3M Coban Two-Layer Compression System; 3M, St Paul, MN) compared with other 2-layer (2LB) and 4-layer (4LB) compression systems in patients with noninfected venous leg ulcers (VLUs). METHODS: The MEDLINE, EMBASE, CINAHL, Cochrane Library, National Health Service (NHS) Economic Evaluation, and EconLit databases were searched from inception up to January 2017. The MEDLINE search was updated on March 31, 2017. Study selection, quality assessment, and data synthesis were undertaken in accordance with recommended standards. Findings were presented narratively. RESULTS: In total, 5 studies (N = 1509 patients) of mixed methodological quality were included. At 6 months, 2LBA achieved better ulcer healing in comparison with 2LBB (odds ratio [OR], 1.57; 95% confidence interval [CI], 1.10-2.24; P = .03) and 4LBA (OR, 1.93, 95% CI, 1.26-2.97; P = .05) in patients with newly diagnosed ulcers only. For a combined population with newly diagnosed and existing VLUs, healing outcomes were OR, 2.87; 95% CI, 1.06-7.77; P = .04, and OR, 16.51; 95% CI, 2.08-131.37; P = .008, for 2LBs and 4LBs, respectively. Results on slippage were inconclusive. Adverse events were infrequent and did not differ significantly between interventions. Lower 6-month NHS costs for the combined population (£2413 vs. £2707 or £2648) and for newly diagnosed patients (£3045 vs. £3842 or £4480) were observed comparing 2LBA with 2LBB or 4LBA. Also, 2LBA was associated with better health-related quality of life (HRQoL) at 6 months. CONCLUSIONS: Based on these findings, 2LBA may result in lower treatment costs and better ulcer healing and HRQoL compared with other multicomponent therapies, especially in patients with newly diagnosed VLUs. However, further high-quality research is needed, especially for outcomes such as slippage and bandage wear time.

[Compression Therapy in Patients with Leg Ulcers - which Costs do Really Occur?] / Kompressionstherapie bei Patienten mit Ulcus cruris ­ welche Kosten entstehen wirklich?

INTRODUCTION: Patients with leg ulcers often have severe edema of the lower extremities, which should be treated as part of a successful wound treatment. Today in Germany the necessary compression therapies are often performed with very error-prone and time-consuming short-stretch bandages only. Multicomponent systems, adaptive compression bandages and leg ulcer stocking systems are newer, much less error-prone treatment options. In addition to the often lacking knowledge, the fears of high costs are also mentioned as reasons for the lack of prescription of these systems. It was therefore our aim to investigate the costs of different treatment options, differentiated in the outpatient and inpatient sector. METHODS: For the economic calculations, both material and personnel costs were taken into account for different scenarios. RESULTS: Both material and personnel costs were included in the calculation. We were able to demonstrate that the cost for a continuous compression therapy for inpatients accrues between 5.29 Euros to 18.50 Euros per day. For the outpatient setting costs of 2.29 Euros to 34.29 Euros per day were calculated. The different constellations of compression therapy can make sense thus not only for medically but also for economically aspects. CONCLUSION: As a consequence of this data, both the different systems and the economic factors of compression therapy in patients with leg ulcers should be known to the therapists. These treatment options should then be prescribed and performed according to individual factors, taking into account the needs and abilities of the patients.

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.

Measuring costs and quality of life for venous leg ulcers.

Venous leg ulcers (VLUs) result in substantial economic costs and reduced quality of life (QoL); however, there are few Australian cost estimates, especially using patient-level data. We measured community-setting VLU management costs and the impact on the QoL of affected individuals. VLU patients were recruited from a specialist wound clinic, an outpatient clinic, and two community care clinics in Queensland. Cost data were collected at the baseline visit. QoL (EQ-5D-5L) and wound status data were collected at baseline, 1, 3, and 6 months. Patients were classified into guideline-based/optimal care and usual care groups. Average weekly costs per patient were statistically significantly different between the usual care and optimal care groups-$214.61 and $294.72, respectively (P = 0.04). Baseline average QoL score for an unhealed ulcer was significantly higher in the optimal care group compared with usual care (P = 0.025). Time to healing differed between the usual care group and the optimal care group (P = 0.04), with averages of 3.9 and 2.7 months, respectively. These findings increase the understanding of the costs, QoL, and healing outcomes of VLU care. Higher optimal care costs may be offset by faster time to healing. This study provides data to inform an economic evaluation of guideline-based care for VLUs.

Cost-effectiveness analysis of guideline-based optimal care for venous leg ulcers in Australia.

BACKGROUND: Venous leg ulcers (VLUs) are expensive to treat and impair quality of life of affected individuals. Although improved healing and reduced recurrence rates have been observed following the introduction of evidence-based guidelines, a significant evidence-practice gap exists. Compression is the recommended first-line therapy for treatment of VLUs but unlike many other developed countries, the Australian health system does not subsidise compression therapy. The objective of this study is to estimate the cost-effectiveness of guideline-based care for VLUs that includes public sector reimbursement for compression therapy for affected individuals in Australia. METHODS: A Markov model was designed to simulate the progression of VLU for patients receiving guideline-based optimal prevention and treatment, with reimbursement for compression therapy, and then compared to usual care in each State and Territory in Australia. Model inputs were derived from published literature, expert opinion, and government documents. The primary outcomes were changes to costs and health outcomes from a decision to implement guideline-based optimal care compared with the continuation of usual care. Sensitivity analyses were performed to test the robustness of model results. RESULTS: Guideline-based optimal care incurred lower total costs and improved quality of life of patients in all States and Territories in Australia regardless of the health service provider. We estimated that providing compression therapy products to affected individuals would cost the health system an additional AUD 270 million over 5 years but would result in cost savings of about AUD 1.4 billion to the health system over the same period. An evaluation of unfavourable values for key model parameters revealed a wide margin of confidence to support the findings. CONCLUSIONS: This study shows that guideline-based optimal care would be a cost-effective and cost-saving strategy to manage VLUs in Australia. Results from this study support wider adoption of guideline-based care for VLUs and the reimbursement of compression therapy. Other countries that face similar issues may benefit from investing in guideline-based wound care.

Closure of Large Percutaneous Femoral Venous Access Using a Modified "Figure-of-Eight" Suture.

Recent advances in different percutaneous treatments made insertion of large-caliber sheaths in the femoral veins more common. Venous punctures are historically managed by initial manual compression with subsequent application of a compression bandage and bed rest. We describe a modified "figure-of-eight" suture technique for minimizing the risk of accidental puncture of the vein while grabbing the subcutaneous tissue. We examined the safety and feasibility of this technique combined with early mobilization in a real-world setting. We performed a retrospective analysis on 56 consecutive patients undergoing percutaneous mitral valve repair using large femoral venous access. The patient population was heterogeneous and bleeding risk characteristics were common. Bleeding Academic Research Consortium Consensus (BARC)-classifiable bleeding complications occurred in eight patients (14%), BARC of two events or more in five patients (8.9%), and BARC of three or more event in only one patient (1.8%), which is a comparable success rate to large venous access closure with suture-mediated closure devices. No BARC Type 3b or BARC Type 5 bleeding occurred. During routine clinical follow-up, no groin-related problems were reported in all patients. Closure of large femoral venous access using a modified temporary subcutaneous figure-of-eight suture in combination of a light compression bandage and bed rest for 2 to 4 hours provides a safe and low-cost alternative to closure devices for early mobilization.

Cost-effectiveness of an electroceutical device in treating non-healing venous leg ulcers: results of an RCT.

OBJECTIVE: To estimate the cost-effectiveness of an externally applied electroceutical (EAE) device, Accel-Heal, in treating non-healing venous leg ulcers (VLUs) in the UK. METHOD: This was a prospective, randomised, double-blind, placebo-controlled, multi-centre study of patients aged ≥18 years with a non-healing VLU. Patients were randomised in the ratio of 1:1 to receive six units of the EAE (consisting of a self-contained, programmed electric microcurrent generator and two skin contact pads) or an identical-looking placebo device over 12 consecutive days. Patients were followed-up for 24 weeks from randomisation, during which time patients received wound care according to the local standard care pathway, completed health-related quality of life (HRQoL) instruments, and health-care resource use was measured. The cost-effectiveness of the EAE device was estimated at 2015/16 prices in those patients who fulfilled the study's inclusion and exclusion criteria (economic analysis population). RESULTS: At 24 weeks after randomisation, 34% and 30% of VLUs in the EAE and placebo groups in the economic analysis population, respectively, had healed. The time-to-healing was a mean of 2.6 and 3.5 months in the EAE and placebo groups, respectively. The area of the wounds that healed in the EAE group was nearly twice that of those in the placebo group (mean: 13.3 versus 7.7cm2 per VLU). Additionally, the pre-randomised duration of the wounds that healed in the EAE group was double that of those in the placebo group (mean: 2.6 versus 1.2 years per VLU). By the end of the study, EAE-treated patients reported less pain, more social functioning and greater overall wellbeing/satisfaction than placebo-treated patients. None of these differences reached statistical significance, but they may be important to patients. There were no significant differences in health-care resource use between the two groups. The incremental cost per quality-adjusted life year (QALY) gained with the EAE device was £4480 at eight weeks, decreasing to £2265 at 16 weeks and -£2388 (dominant) at 24 weeks. The study was confounded by unwarranted variation in patient management between centres and between individual clinicians within each centre. CONCLUSION: Despite the unwarranted variation in the provision of wound care observed in this study, the use of the EAE device resulted in some improved clinical outcomes and patient-reported outcomes, for the same or less cost as standard care, by 24 weeks. Clinicians managing VLUs may wish to consider the findings from this study when making treatment decisions.

Cost-effectiveness of using a collagen-containing dressing plus compression therapy in non-healing venous leg ulcers.

OBJECTIVE: To estimate whether collagen-containing dressings could potentially afford the UK's National Health Service (NHS) a cost-effective intervention for the management of non-healing venous leg ulcers (VLUs). METHOD: This was a modelling study performed from the perspective of the UK's NHS. A combination of published clinical outcomes, resource utilisation estimates and utilities for VLUs enabled the construction of a decision model, depicting the management of a chronic VLU with standard care or with a collagen-containing dressing plus compression therapy followed by standard care, over a period of 6 months. The model estimated the incremental cost-effectiveness of the two interventions in terms of the incremental cost per quality-adjusted life year (QALY) gained at 2015/16 prices. RESULTS: The treatment of VLUs of >6 months' duration with a collagen-containing dressing plus compression therapy followed by standard care, instead of standard care, is expected to increase the probability of healing from 0.11 to 0.49 by 6 months and increase health-related quality of life at 6 months from 0.331 to 0.373 QALYs per patient. Additionally, treatment with a collagen-containing dressing plus compression therapy followed by standard care has the potential to reduce management costs by 40% over 6 months when compared with standard care (from £6328 to £3789 per patient). CONCLUSION: Within the study's limitations, including a collagen-containing dressing into a standard care protocol compared with standard care potentially affords the NHS a cost-effective (dominant) treatment since it improves outcomes for less cost.

Venous leg ulcer management in clinical practice in the UK: costs and outcomes.

The aim of this study was to estimate the patterns of care and annual levels of health care resource use attributable to managing venous leg ulcers (VLUs) in clinical practice by the UK's National Health Service (NHS) and the associated costs of patient management. This was a retrospective cohort analysis of the records of 505 patients in The Health Improvement Network (THIN) Database. Patients' characteristics, wound-related health outcomes and health care resource use were quantified, and the total NHS cost of patient management was estimated at 2015/2016 prices. Overall, 53% of all VLUs healed within 12 months, and the mean time to healing was 3·0 months. 13% of patients were never prescribed any recognised compression system, and 78% of their wounds healed. Of the 87% who were prescribed a recognised compression system, 52% of wounds healed. Patients were predominantly managed in the community by nurses with minimal clinical involvement of specialist clinicians. Up to 30% of all the VLUs may have been clinically infected at the time of presentation, and only 22% of patients had an ankle brachial pressure index documented in their records. The mean NHS cost of wound care over 12 months was an estimated £7600 per VLU. However, the cost of managing an unhealed VLU was 4·5 times more than that of managing a healed VLU (£3000 per healed VLU and £13 500 per unhealed VLU). This study provides important insights into a number of aspects of VLU management in clinical practice that have been difficult to ascertain from other studies and provides the best estimate available of NHS resource use and costs with which to inform policy and budgetary decisions.

Clinical outcomes and cost-effectiveness of three different compression systems in newly-diagnosed venous leg ulcers in the UK.

OBJECTIVE: To assess clinical outcomes and cost-effectiveness of using a two-layer cohesive compression bandage (TLCCB; Coban 2) compared with a two-layer compression system (TLCS; KTwo) and a four-layer compression system (FLCS; Profore) in treating newly-diagnosed venous leg ulcers (VLUs) in clinical practice in the UK, from the perspective of the NHS. METHOD: This was a retrospective cohort analysis of the case records of patients with newly-diagnosed VLUs randomly extracted from The Health Improvement Network (THIN) database (a nationally representative database of clinical practice among patients registered with general practitioners in the UK) who were treated with either TLCCB (n=200), TLCS (n=200) or FLCS (n=200). The clinical outcomes and cost-effectiveness of the alternative compression systems were estimated over six months after starting treatment. RESULTS: Patients' mean age was 72 years and 58% were female. Time from wound onset to the start of compression was a mean of two months, and when starting compression the wound size was a mean of 45 cm2. The distribution of healing was significantly different between the three groups; 76% of wounds in the TLCCB group healed by six months compared with 70% and 64% in the TLCS and FLCS groups, respectively (p=0.006). Time to healing was significantly less in the TLCCB group compared with the two other groups (p=0.003). Patients in the TLCCB group experienced better health-related quality of life over six months (0.413 quality-adjusted life years (QALYs) per patient), compared with the TLCS and FLCS groups (0.404 and 0.396 QALYs per patient, respectively). The mean six-month NHS management cost was £3045, £3842 and £4480 per patient in the TLCCB, TLCS and FLCS groups, respectively. CONCLUSION: Real-world evidence demonstrates that treating newly-diagnosed VLUs with TLCCB, compared with the other two compression systems, affords a more cost-effective use of NHS-funded resources in clinical practice since it resulted in an increased healing rate, better health-related quality of life and a reduction in NHS management cost.

Cost comparison of three kinds of compression therapy in venous ulcer.

Evolution and cost of three types of compression therapy (single layer, multilayer and Unna boot) in patients with venous ulceration were compared. The evaluation lasted two months and used photographic records and instrument based on pressure ulcer scale for healing (PUSH). Treatment with monolayer compression therapy presented the lowest cost and more efficacy of the three types, with 82% savings compared with the multilayer therapy.

Cost comparison of three kinds of compression therapy in venous ulcer

Abstract: Evolution and cost of three types of compression therapy (single layer, multilayer and Unna boot) in patients with venous ulceration were compared. The evaluation lasted two months and used photographic records and instrument based on pressure ulcer scale for healing (PUSH). Treatment with monolayer compression therapy presented the lowest cost and more efficacy of the three types, with 82% savings compared with the multilayer therapy.

What is the effect of treating secondary lymphedema after breast cancer with complete decongestive physiotherapy when the bandage is replaced with Kinesio Textape? - A pilot study.

PURPOSE: Secondary lymphedema (SL) following breast cancer is a well-known complication following surgery or radiation. SL may result in loss of functional ability, cosmetic deformities, physical discomfort, recurrent episodes of erysipelas, and psychological distress. There is no evidence as to what is the most effective treatment for SL. METHODS: This randomized controlled pilot study included 10 patients treated for SL following breast cancer. The patients were included and screened for SL by a physiotherapist. They were randomized to treatment with CDP with Kinesio Textape or bandage for 4 weeks. Endpoints were quality of life, circumference of the arm, costs, and working environment for the physiotherapist. RESULTS: The two groups were comparable according to baseline data. Outcomes on quality of life, costs, and working environment for the physiotherapist; the treatment with CDP with tape was superior to the CDP with bandage treatment. In regard to reducing the circumference there was no difference. CONCLUSIONS: This randomized controlled pilot study shows that CDP with tape can be an alternative to CDP with bandage. The quality of life is higher, the economy and working environment is better, and the effect measured by circumference is comparable. More RCTs are required to increase the evidence for CDP with tape. IMPLICATIONS: Treating lymphedema with CDP with tape after breast cancer is a good alternative to CDP with bandage and makes it possible to treat more patients with less resources.

[Challenges of aging skin: Care and therapy using the example of venous ulcers]. / Herausforderungen der alternden Haut : Versorgung und Therapie am Beispiel des Ulcus cruris.

BACKGROUND: One of the most significant, and growing, challenges in modern medicine, i.e. the treatment of chronic wounds, is marked by nonuniform data. This concerns both prevalence and incidence of chronic dermatosis, in particular venous ulcers (ulcus cruris), as well as the impact on the health-related quality of life, and practical and economic parameters of the success of different therapies. PURPOSE: The aim of this work is to examine the epidemiology of chronic wounds, in particular age-associated venous ulcers, their impact on health-related quality of life, the treatment regimen, and practical and economic parameters of the success of different therapies. MATERIALS AND METHODS: Performed were analysis of data on the care of venous ulcers in Germany, based on secondary data of Barmer GEK from 2009 and 2012, comparison with data of a NHS Kent Community Health Trust study, and analysis of studies concerning structures, processes and critical success factors for the treatment of chronic wounds, including economic effects. CONCLUSION: Early causal therapy with treatment based on the stage of the wound, consequent goal-oriented interdisciplinary care, and relapse prophylaxis is critical for successful healing of venous ulcers. The costs of treatment significantly correlate with the duration of treatment which can be reduced by up to 60% using guideline-based concepts for the treatment of chronic wounds. Treatment success, in particular with regard to cost-benefit considerations, can be optimized by telemedicine networks of key players who treat chronic wounds.

Clinical outcomes and cost-effectiveness of an externally applied electroceutical device in managing venous leg ulcers in clinical practice in the UK.

OBJECTIVE: To estimate the cost-effectiveness of treating patients with a venous leg ulcer (VLU) with an externally applied electroceutical (EAE) device, plus dressings and compression bandaging or continuing with their previous care plan, from the perspective of the National Health Service (NHS) in the UK. METHOD: This was a prospective, single-arm, non-blinded, clinical and economic evaluation of EAE therapy performed in 2013/14. Patients' VLUs were treated with six active units of EAE therapy (each unit for two days) plus dressings and compression bandaging over a period of 12 days. Afterwards, patients were managed with a combination of dressings and bandages. Each patient acted as their own control so that clinical outcomes, resource use and costs associated with the wound over 12 months before the start of EAE therapy were retrospectively compared with the first 12 months after the start of treatment. The relative cost-effectiveness of EAE therapy was estimated at 2013/14 prices. RESULTS: Within 12 months of starting EAE therapy 77% of all wounds healed and the other 23% improved. This difference in effectiveness between the 12-months period before and after EAE therapy was estimated to yield a 12% improvement in health gain of 0.09 QALYs (p<0.01), a 34% reduction in the requirement for nurse visits (from a mean 50.7 to 33.3 visits per patient) and a 26% reduction in the number of dressings. This resulted in an 11% reduction in the NHS cost of VLU management over 12 months after the start of treatment when compared with the previous 12 months (from £1,981 to £1,754 per patient). Hence, use of EAE therapy was found to be a dominant treatment (i.e. improved outcome for less cost). CONCLUSION: Within the study's limitations, use of the EAE device potentially affords the NHS a cost-effective treatment for managing VLUs when compared with patients remaining on their previous care plan.