High Pressure 3 × 30 Minute Compression Methods for Advanced Lower Limb Lymphedema Patients.

Introduction: In advanced lymphedema of lower limbs, stage III bandaging under the routinely applied pressure of 40-60 mmHg remains largely ineffective. This is caused by skin and subcutaneous tissue stiffness due to fibrosis. Edema fluid accumulates deep in the subcutaneous tissue. Evacuating this fluid requires a high external compression force to overcome the resistance of fibrous tissue. We aimed to investigate the effectiveness of the compression method, with high pressure lasting for 3 days. Methods and Results: Twenty-one patients with lower limb lymphedema, stage III, of the postinflammatory type were included. Patients with acute inflammatory symptoms, venous thrombosis, profuse varicose veins, diabetes, and cardiac insufficiency with edema were excluded. A 10-cm-wide rubber bandage was applied to the foot and calf. The interface pressure measured using PicoPress ranged from 58 to 120 mmHg. Skin and deep tissue tonometry, skin water concentration, leg circumference, and drop of interface pressure were measured. Ultrasound examination was done before and after each compression session. The calf circumference decreased by 15.9 ± 5.4%, deep tissue stiffness by 58.9 ± 18.9%, skin stiffness by 69.6 ± 13.5%, and skin water concentration by 43.8 ± 11.5%. Interface pressure dropped to 66.3 mmHg (28-110 mmHg); ultrasonography images showed less fluid in the tissue. Conclusions: High-pressure 30-minute leg compression can remove excess edema fluid within 3 days and enable adjustment of nonstretch compression stockings. This method is more effective in advanced lymphedema at the beginning of therapy than the standard 30-50-mmHg bandaging as it provides an immediate effect.

An innovative flat-knit compression garment for lymphoedema patients led to better outcomes: a multicentre study.

OBJECTIVE: To evaluate the clinical performance, quality of life (QoL) and patient satisfaction with an innovative flat-knit compression garment for the daytime treatment of lymphoedema patients in daily routine. METHOD: In a prospective multicentre observational study, patients with leg or arm lymphoedema (stage I-II, International Society of Lymphology (ISL) standards, 2016) received a made-to-measure flat-knit compression class 2 JOBST Confidence (BSN-JOBST GmbH, Germany) thigh-high stocking or arm sleeve. Primary endpoint was the oedema status as determined by the mean sum of the circumferences at the beginning and the end of the wearing period. Secondary endpoints included QoL-related parameters and patient satisfaction with product features assessed through questionnaires. The observation period lasted three weeks. RESULTS: A total of 97 patients (87 females, 10 males), of which 65 had leg lymphoedema and 32 had arm lymphoedema, received the study device. The oedema status was effectively maintained (slight reduction in mean sum of circumferences by -3.1±7.3cm; p=0.0001). For QoL-related parameters, the patients reported fewer limitations in work, leisure and psychological wellbeing after wearing the stocking or arm sleeve (all p-values <0.0001). They also experienced less limitations in function and movement, feeling of tension and heaviness, and fewer difficulties wearing clothes, shoes, jewellery or watches at study end (all p-values <0.0001). In terms of pleasant feeling on the skin, moisture management, softness of material, range of motion, overall wearing comfort and heat build-up under the garment, patients were more satisfied with the tested compression garment than with previously worn compression garments (all p-values <0.001). CONCLUSION: In this study, the tested innovative compression product increased patient satisfaction with the improved product features while the lymphoedema status was successfully maintained.

Compression for preventing recurrence of venous ulcers.

BACKGROUND: Up to 1% of adults will have a leg ulcer at some time. Most leg ulcers are venous in origin and are caused by high pressure in the veins due to blockage or damaged valves. Venous ulcer prevention and treatment typically involves the application of compression bandages/stockings to improve venous return and thus reduce pressure in the legs. Other treatment options involve removing or repairing veins. Most venous ulcers heal with compression therapy, but ulcer recurrence is common. For this reason, clinical guidelines recommend that people continue with compression treatment after their ulcer has healed. This is an update of a Cochrane review first published in 2000 and last updated in 2014. OBJECTIVES: To assess the effects of compression (socks, stockings, tights, bandages) for preventing recurrence of venous leg ulcers. SEARCH METHODS: In August 2023, we searched the Cochrane Wounds Specialised Register, CENTRAL, MEDLINE, Embase, three other databases, and two ongoing trials registries. We also scanned the reference lists of included studies and relevant reviews and health technology reports. There were no restrictions on language, date of publication, or study setting. SELECTION CRITERIA: We included randomised controlled trials (RCTs) that evaluated compression bandages or hosiery for preventing the recurrence of venous ulcers. DATA COLLECTION AND ANALYSIS: At least two review authors independently selected studies, assessed risk of bias, and extracted data. Our primary outcome was reulceration (ulcer recurrence anywhere on the treated leg). Our secondary outcomes included duration of reulceration episodes, proportion of follow-up without ulcers, ulceration on the contralateral leg, noncompliance with compression therapy, comfort, and adverse effects. We assessed the certainty of evidence using GRADE methodology. MAIN RESULTS: We included eight studies (1995 participants), which were published between 1995 and 2019. The median study sample size was 249 participants. The studies evaluated different classes of compression (UK class 2 or 3 and European (EU) class 1, 2, or 3). Duration of follow-up ranged from six months to 10 years. We downgraded the certainty of the evidence for risk of bias (lack of blinding), imprecision, and indirectness. EU class 3 compression stockings may reduce reulceration compared with no compression over six months (risk ratio (RR) 0.46, 95% confidence interval (CI) 0.27 to 0.76; 1 study, 153 participants; low-certainty evidence). EU class 1 compression stockings compared with EU class 2 compression stockings may have little or no effect on reulceration over 12 months (RR 1.70, 95% CI 0.67 to 4.32; 1 study, 99 participants; low-certainty evidence). There may be little or no difference in rates of noncompliance over 12 months between people using EU class 1 stockings and people using EU class 2 stockings (RR 1.22, 95% CI 0.40 to 3.75; 1 study, 99 participants; low-certainty evidence). UK class 2 hosiery compared with UK class 3 hosiery may be associated with a higher risk of reulceration over 18 months to 10 years (RR 1.55, 95% CI 1.26 to 1.91; 5 studies, 1314 participants; low-certainty evidence). People who use UK class 2 hosiery may be more compliant with compression treatment than people who use UK class 3 hosiery over 18 months to 10 years (RR for noncompliance 0.69, 95% CI 0.49 to 0.99; 5 studies, 1372 participants; low-certainty evidence). There may be little or no difference between Scholl UK class 2 compression stockings and Medi UK class 2 compression stockings in terms of reulceration (RR 0.77, 95% CI 0.47 to 1.28; 1 study, 166 participants; low-certainty evidence) and noncompliance (RR 0.97, 95% CI 0.84.1 to 12; 1 study, 166 participants; low-certainty evidence) over 18 months. No studies compared different lengths of compression (e.g. below-knee versus above-knee), and no studies measured duration of reulceration episodes, ulceration on the contralateral leg, proportion of follow-up without ulcers, comfort, or adverse effects. AUTHORS' CONCLUSIONS: Compression with EU class 3 compression stockings may reduce reulceration compared with no compression over six months. Use of EU class 1 compression stockings compared with EU class 2 compression stockings may result in little or no difference in reulceration and noncompliance over 12 months. UK class 3 compression hosiery may reduce reulceration compared with UK class 2 compression hosiery; however, higher compression may lead to lower compliance. There may be little to no difference between Scholl and Medi UK class 2 compression stockings in terms of reulceration and noncompliance. There was no information on duration of reulceration episodes, ulceration on the contralateral leg, proportion of follow-up without ulcers, comfort, or adverse effects. More research is needed to investigate acceptable modes of long-term compression therapy for people at risk of recurrent venous ulceration. Future trials should consider interventions to improve compliance with compression treatment, as higher compression may result in lower rates of reulceration.

A systematic review of the impact of compression therapy on quality of life and pain among people with a venous leg ulcer.

AIM: To gain a greater understanding of how compression therapy affects quality of life, this systematic review appraised existing published studies measuring the impact of compression therapy on health quality of life (HRQoL), and pain, among people with venous leg ulcers (VLU). METHOD: Five databases were searched, and two authors extracted data and appraised the quality of selected papers using the RevMan risk of bias tool. Due to heterogeneity in the types of compression and instruments used to evaluate HRQoL, meta-analysis was not appropriate; thus, a narrative synthesis of findings was undertaken. RESULTS: Ten studies were included, 9 RCTs and one before-after study. The studies employed nine different HRQoL tools to measure the impact of a variety of compression therapy systems, with or without an additional exercise programme, versus other compression systems or usual care, and the results are mixed. With the use of the Cardiff Cardiff Wound Impact Schedule, the SF-8 and the SF-12, study authors found no differences in QoL scores between the study groups. This is similar to one study using QUALYs (Iglesias et al., 2004). Conversely, for studies using EuroQol-5D, VEINES-QOL, SF-36 and CIVIQ-20 differences in QoL scores between the study groups were noted, in favour of the study intervention groups. Two further studies using QUALYs found results that favoured a two-layer cohesive compression bandage and the TLCCB group, respectively. Results for the five studies that assessed pain are also mixed, with one study finding no difference between study groups, one finding that pain increased over the study period and three studies finding that pain reduced in the intervention groups. All studies were assessed as being at risk of bias in one or more domains. CONCLUSION: Results were varied, reflecting uncertainty in determining the impact of compression therapy on quality of life and pain among people with a venous leg ulcer. The heterogeneity of the compression systems and the measures used to evaluate HRQoL make it a challenge to interpret the overall evidence. Further studies should strive for homogeneity in design, interventions and comparators to enhance both internal and external validity.

Decision-making on the use of compression hosiery and compression bandaging: a systematic review.

This systematic literature review was carried out by a final-year nursing student in response to clinical experience, and to understand the rationale and evidence around managing venous ulcers. In the student's clinical experience, the two most commonly used treatment methods were forms of compression hosiery and compression bandaging. The CINAHL, Science Direct, Cochrane Library, Internurse and MEDLINE databases were searched for literature published over the period 2003-2023. From the resulting five papers, five key themes were identified: types of compression systems used and the rationale for decision-making; clinical effectiveness; the impact on patient experience and quality of life; pain levels following application of compression systems; and cost effectiveness. Conclusion: Management and prevention of venous ulceration is complex. The decisions should be made in partnership with the patient and will be influenced by context. Overall, compression hosiery was identified as the more favourable system.

Comparing easywrap with six other adjustable wraps for compression therapy in venous and lymphatic disease by variation in pressure, stiffness and elasticity.

BACKGROUND: There is no clear guidance or comprehensive comparative evidence to help clinicians select between adjustable wraps for compression therapy. However, adjustable wraps could be compared with three metrics used for compression bandages: variation in pressure, stiffness and elasticity. AIMS: To determine whether easywrap (Haddenham Healthcare) had lower standard deviation (SD) in lying pressure, greater static stiffness index (SSI) and/or a greater mean elongation ratio than six other adjustable wraps. METHODS: In this preliminary exploratory study, seven adjustable wraps were tested in vivo 20 times each (140 tests in total), on 20 people (with a variable number of readings per participant), to give the SD in lying pressure and mean SSI. The same wraps were tested in vitro five times each to give the mean elongation ratio. FINDINGS: Of all seven adjustable wraps, easywrap had the second lowest SD in lying pressure at 5.9 mmHg, compared with 8.9 mmHg overall; the highest mean SSI at 13.2 mmHg, compared with 9.5 mmHg overall; and the highest mean elongation ratio at 137.0%, compared with 107.1% overall. CONCLUSIONS: These metrics suggest that easywrap has clinical advantages over other adjustable wraps. A lower variation in lying pressure suggests more consistent application of pressures within intended therapeutic levels. Higher SSI indicates greater resistance to stretching, which is linked to improved venous function and oedema reduction. Higher elongation ratio demonstrates greater tensile strength, which should maintain therapeutic pressure for longer without readjustment.

Effect of Ankle Brachial Index (ABI) and Compression Therapy on Diabetic Foot Ulcer Healing.

PURPOSE: Knowing the effect of compression therapy on the value of the Ankle Brachial Index in the healing process of Diabetic Foot Ulcer. DESIGN: This study used a quasi-experimental method with pretest-posttest with control group design with purposive sampling and non-equivalent control groups for eight weeks of treatment. SUBJECTS AND SETTING: Patients diagnosed with Diabetic Foot Ulcer have and have Peripheral Artery Disease, patient characteristics are homogenized, age >18 years, wound care every three days, Ankle Brachial Index values between 0.6-1.3 mmHg, research three clinics in Indonesia in February 2021. METHODS: The population with Diabetic Foot Ulcer was screened by inclusion criteria with Ankle Brachial Index and Bates-Jensen Wound Assessment Tool instruments, a total of n=140; in the study, thirteen samples were excluded, the intervention group was given Compression Therapy n= 68, and the control group was compression stockings for eight weeks n=59, the data were statistically analyzed non-parametric test using Wilcoxon and Mann-Whitney U. RESULTS: Statistical analysis showed that the mean difference in paired group means was 26.4%. Meanwhile, in the mean analysis, the difference in the post-test healing of diabetic foot ulcers was 2.83%; p=0.000 and improvement of peripheral microcirculation was 33.02%; p=0.000 in the eighth week. Thus, compression therapy intervention in diabetic foot ulcer patients can improve peripheral microcirculation and increase Diabetic Foot Ulcers healing compared to the control group. CONCLUSION: Compression therapy tailored to the patient's needs and according to standard operating procedures can improve peripheral microcirculation, so that blood flow in the legs becomes normal; it can speed up the healing process of Diabetic Foot Ulcers.

Testing the feasibility of a co-designed intervention, comprising self-managed, home-based, exercise training with embedded behavioural support and compression therapy for people with venous leg ulcers receiving treatment at home (FISCU-II).

BACKGROUND: Venous leg ulcers (VLUs) heal slowly, are painful for patients and are costly for healthcare systems; they also affect patients' quality of life. Previous work suggests that supervised exercise training used in combination with compression therapy may offer clinical benefits. However, a large population of people with VLUs are unable to access such an intervention due to frailty and age. OBJECTIVES: To assess the feasibility of 'FISCU Home' (a co-designed, 12-week home-based self-managed lifestyle programme based on exercise and behaviour support) as an adjunct therapy to compression in people with VLUs. METHODS: Forty people with VLUs, receiving treatment at home, were recruited from community nursing and tissue viability teams, and via a newspaper advertisement. Participants were randomized 1 : 1 either to exercise with behaviour support (three times per week) plus compression therapy or compression only. The feasibility of the programme was assessed using progression criteria that included exercise attendance rate, loss to follow-up, patient preference(s) and adverse events (AEs). Baseline assessments were repeated at 12 weeks and 6 months. Secondary outcomes (i.e. ulcer recurrence, healing rate and healing time) were also documented at these intervals. Intervention and healthcare utilization costs were calculated. RESULTS: The study recruitment rate was 65%, while 75% of the exercise group participants attended all scheduled exercise sessions. All participants completed compression therapy. No serious AEs or exercise-related AEs were reported. Median (interquartile range) ulcer healing time was shorter in the exercise group [29 (7-108) vs. 42 (6-116) weeks]. CONCLUSIONS: The feasibility and acceptability of both a home- and exercise-based lifestyle intervention in conjunction with compression therapy and the study procedures are supported.

Protocolo de uso de los sistemas de velcros yuxtapuestos para el abordaje de úlceras venosas de piernas en el Servicio Andaluz de Salud / Protocol for the use of juxtaposed velcro systems to address venous leg ulcers in the Andalusian Health Service

Objetivos: El objetivo principal de este estudio es elaborar un protocolo de indicación de los sistemas de velcros yuxtapuestos para el abordaje de la úlcera venosa de pierna en el Servicio Andaluz de Salud. Para su consecución se llevó a cabo un análisis de coste-efectividad de los diferentes sistemas de vendas existentes como productos sanitarios para el tratamiento de úlceras de etiología venosa, donde se evaluó los sistemas de velcros yuxtapuestos para su incorporación e inclusión en la plataforma logística del sistema sanitario público andaluz. Para su consecución, se llevó a cabo un análisis de la evidencia disponibles sobre los del sistema de velcros yuxtapuestos en pacientes con úlceras venosas de piernas. Y finalmente se desarrollaron los criterios de autorización en el uso de los sistemas de velcros yuxtapuestos por parte de los profesionales sanitarios del sistema sanitario público andaluz. Resultados: El sistema de vendas de velcros yuxtapuestos está avalado por la evidencia científica para su empleo en úlceras venosas en miembro inferior, así como para el tratamiento para la prevención de las recidivas. Asimismo, en este artículo se compara el sistema de vendas de velcros yuxtapuestos con otros sistemas de vendas instaurados, y muestra ser un producto sanitario coste-efectivo. Discusión: El sistema de vendaje de velcros yuxtapuestos proporciona una autonomía y una mejora de la calidad de vida a los pacientes con dificultades para usar una media o que no tengan posibilidad de que un profesional sanitario realice los cambios de vendaje. Es un sistema coste-efectivo para el tratamiento de las úlceras venosas de pierna.(AU)

Objectives: The main objective of this study is to develop a protocol for the indication of juxtaposed velcro systems for the approach to UVP in the Andalusian Health Service. To achieve this, a cost-effectiveness analysis of the different bandage systems existing as sanitary products for the treatment of ulcers of venous etiology was carried out, where the juxtaposed velcro systems were evaluated for their incorporation and inclusion in the logistics platform of the Andalusian public health system (SSPA). To achieve this, an analysis of the available evidence on the juxtaposed velcro system in patients with UVP was carried out. And finally, the authorization criteria for the use of juxtaposed velcro systems by health professionals of the SSPA were developed. Results: The juxtaposed velcro bandage system is supported by scientific evidence for its use in venous ulcers in the lower limb, as well as for treatment to prevent recurrences. Likewise, in this article it is compared with other established bandage systems, showing it to be a cost-effective health product. Discussion: The juxtaposed velcro bandage system provides autonomy and an improvement in the quality of life for those patients with difficulties in wearing a stocking or who do not have the possibility of a healthcare professional making bandage changes. Being a cost-effective system for the treatment of venous leg ulcers.(AU)

Comparing easywrap with six other adjustable wraps for compression therapy in venous and lymphatic disease by variation in pressure, stiffness and elasticity.

BACKGROUND: There is no clear guidance or comprehensive comparative evidence to help clinicians select between adjustable wraps for compression therapy. However, adjustable wraps could be compared with three metrics used for compression bandages: variation in pressure, stiffness and elasticity. AIMS: To determine whether easywrap (Haddenham Healthcare) had lower standard deviation (SD) in lying pressure, greater static stiffness index (SSI) and/or a greater mean elongation ratio than six other adjustable wraps. METHODS: In this preliminary exploratory study, seven adjustable wraps were tested in vivo 20 times each (140 tests in total), on 20 people (with a variable number of readings per participant), to give the SD in lying pressure and mean SSI. The same wraps were tested in vitro five times each to give the mean elongation ratio. FINDINGS: Of all seven adjustable wraps, easywrap had the second lowest SD in lying pressure at 5.9 mmHg, compared with 8.9 mmHg overall; the highest mean SSI at 13.2 mmHg, compared with 9.5 mmHg overall; and the highest mean elongation ratio at 137.0%, compared with 107.1% overall. CONCLUSIONS: These metrics suggest that easywrap has clinical advantages over other adjustable wraps. A lower variation in lying pressure suggests more consistent application of pressures within intended therapeutic levels. Higher SSI indicates greater resistance to stretching, which is linked to improved venous function and oedema reduction. Higher elongation ratio demonstrates greater tensile strength, which should maintain therapeutic pressure for longer without readjustment.

Análisis costo-efectividad del tratamiento con terapia compresiva en la cicatrización de úlceras venosas / Cost-effectiveness analysis of the treatment with compressive therapy in the healing of venous ulcers / Análise de custo-efetividade do tratamento com terapia compressiva na cicatrização de úlceras venosas

Objetivo: analizar el costo-efectividad y calcular la relación costoefectividad incremental del tratamiento multicapa compresivo con respecto al inelástico (bota de Unna y estiramiento corto) según la literatura actual. Método: estudio cuantitativo de costo-efectividad a través de un modelo con ayuda del software TreeAge® para la elaboración del árbol de decisión. Los supuestos anunciados se obtuvieron mediante el uso de datos secundarios de la literatura para estimar el costo y la efectividad de los parámetros asumidos. Para ello, se realizó una revisión sistemática de la literatura con metaanálisis. Resultados: el árbol de decisión, después del Roll Back, mostró que la terapia multicapa prevaleció sobre las alternativas en el caso base, presentó un costo intermedio por aplicación, pero obtuvo la mayor efectividad. El gráfico del análisis de costo-efectividad también demostró que había un dominio extendido de la bota de Unna sobre el vendaje de estiramiento corto. El análisis de sensibilidad reveló que el vendaje multicapa sigue siendo la alternativa con mayor costoefectividad, dentro del umbral de disposición a pagar. Conclusión: la alternativa con mayor costo-efectividad fue el vendaje multicapa, considerado estándar de oro en la literatura. La segunda alternativa con mayor costo-efectividad fue la bota de Unna, la terapia más utilizada en Brasil.

Objective: to analyze the cost-effectiveness and calculate the incremental cost-effectiveness ratio of multilayer compressive treatment in relation to inelastic (Unna boot and short stretch) therapy according to the current literature. Method: quantitative study about cost-effectiveness through modeling with the aid of TreeAge® software for construction of the decision tree. The anticipated assumptions were obtained by using secondary literature data to estimate the cost and effectiveness of the assumed parameters. A systematic literature review with meta-analysis was performed for this end. Results: the decision tree after Roll Back showed that the multilayer therapy dominated the alternatives in the base case, representing an intermediate cost per application, although with the highest effectiveness. The cost-effectiveness analysis graph also showed extended dominance of the Unna boot in relation to the short stretch bandage. The sensitivity analysis showed that multilayer bandage remains a more cost-effective alternative, within the threshold of willingness to pay. Conclusion: the most cost-effective alternative was multilayer bandage, considered the gold standard in the literature. The second most cost-effective alternative was the Unna boot, the most used therapy in Brazil.

Objetivo: analisar a custo-efetividade e calcular a razão de custoefetividade incremental do tratamento compressivo multicamadas em relação ao inelástico (bota de Unna e curto estiramento) de acordo com a literatura atual. Método: estudo quantitativo sobre custo-efetividade por meio de modelagem com auxílio do software TreeAge® para a construção da árvore de decisão. Os pressupostos anunciados foram obtidos pelo uso de dados secundários de literatura para estimativa do custo e efetividade dos parâmetros assumidos. Para tal, foi realizada uma revisão sistemática de literatura com metanálise. Resultados: a árvore de decisão, após Roll Back mostrou que a terapia multicamadas dominou as alternativas no caso-base, representando custo intermediário por aplicação, porém, com a maior efetividade. O gráfico da análise de custo-efetividade também mostrou uma dominância estendida da bota de Unna em relação à bandagem de curto estiramento. A análise de sensibilidade mostrou que a bandagem multicamadas permanece como alternativa mais custo-efetiva, dentro do limiar de disposição para pagar. Conclusão: a alternativa com maior custo-efetividade foi a bandagem multicamadas, considerada padrão ouro na literatura. A segunda alternativa mais custo-efetiva foi a bota de Unna, terapia mais utilizada no Brasil.

Compression therapies for the treatment of venous leg ulcers: study protocol for a process evaluation in a randomised controlled trial, VenUS 6.

BACKGROUND: The VenUS 6 parallel-group randomised controlled trial (RCT) will compare the clinical and cost-effectiveness of compression wraps, two-layer compression bandage and evidence-based compression therapy, comprising of two-layers of hosiery or four-layer bandages, for healing time of venous leg ulcers. We will conduct an embedded process evaluation to evaluate the implementation of the trial and the various compression therapies and to gain a more in-depth understanding of trial participant and nursing staff views and experiences of these therapies. METHODS: This process evaluation will be a mixed-method study, embedded into a wider RCT. Qualitative data will be collected through semi-structured individual in-depth interviews with trial participants and staff members. Quantitative data will be collected using patient questionnaires and case report forms that are part of the main trial data collection process. Interview transcripts will be analysed using the Framework Analysis and interview data will be integrated with quantitative RCT data using the RE-AIM framework and the Pillar Integration Process. DISCUSSION: We describe the protocol for a process evaluation, designed to assess the implementation of the various venous leg ulcer compression therapies as evaluated in VenUS6, and the experiences of trial participants and nursing staff using these. This protocol provides one example of how an embedded mixed-method process evaluation can be conducted. TRIAL REGISTRATION: ISRCTN 67321719 ( https://doi.org/10.1186/ISRCTN67321719 ). Prospectively registered on 14 September 2020. Recruitment Infographic SWAT-MRC Hub for Trials Methodology Research SWAT repository #116. Registered on 13 April 2020. Retention Thank You Card SWAT-MRC Hub for Trials Methodology Research SWAT repository #119. Registered on 13 April 2020. Retention Newsletter SWAT-MRC Hub for Trials Methodology Research SWAT repository #28. Registered on 01 July 2007. Retention Pen SWAT-MRC Hub for Trials Methodology Research SWAT repository #92. Registered on 01 April 2019. PROTOCOL VERSION: V1.5, 26 May 2022.

Medical device-related pressure injury from compression therapy.

The use of compression therapy is known to be effective in the management of patients with venous leg ulceration and is commonly recommended as a first-line treatment. A rare but known complication of compression therapy is pressure damage to the limb, also referred to as bandage damage, which should be categorised as a medical device-related pressure injury. Patients should receive a comprehensive, holistic assessment before any compression therapy is applied. Risk factors for compression therapy injury include peripheral arterial disease, older age, fragile skin, pronounced bony prominences or tendons, calf atrophy, foot drop, neuropathy/absent sensation, limited movement, cognitive impairment and receiving end of life care. Risks can be mitigated through a variety of approaches, and practitioners should be aware that these can change depending on the patient's condition. A community improvement initiative, illustrated with a case study, introduced a clinical pathway that can facilitate the identification and management of patients who are at risk of developing pressure injuries as a result of compression therapy.

Using Compression Therapy to Treat Bilateral Lower Limb Edema in Patients with Lung Cancer: A Case Series.

ABSTRACT: Although rare, marked bilateral leg edema (BLE) can occur in patients with lung cancer. Systemic therapy for the underlying disease is important, but adjunct therapy might also be helpful. In this case series, the authors report on treating BLE in patients with lung cancer with compression therapy using elastic stockings and bandages. From April 2013 to March 2022, the authors conducted a retrospective survey of seven patients who developed marked BLE and received compression therapy. They evaluated effects based on improvements in subjective symptoms as well as objective findings 2 months after the start of the therapy. The bandage therapy was useful in patients who were driver-gene negative, but it was not effective in those who already had "progressive disease" with specific agents for their driver genes. No adverse events were observed. Compression therapy, even when attached or detached by nonmedical personnel, may provide favorable effects and should be considered as an adjunct treatment option in this population, in addition to effective systemic cancer therapy. These results indicate that a prospective clinical trial would be worthwhile.

Compression therapy for NHS inpatients with leg ulcers: a literature review.

OBJECTIVE: Leg ulcers are common, distressing and painful for patients, and are a significant financial burden to healthcare providers. Compression therapy is the mainstay of treatment for venous leg ulceration. Several studies have evaluated leg ulcer management and compression therapy in the community. However, little is known about the prevalence of leg ulceration and use of compression therapy in acute hospitals. The aim of this study was to explore the published literature on the use of compression therapy for inpatients with leg ulcers in UK National Health Service hospital settings. METHOD: A literature search was undertaken to identify published papers reporting on inpatient leg ulcer populations and the use of compression therapy in hospitals using the following databases: CINAHL, MEDLINE Complete, Embase and PubMed. RESULTS: The literature review identified 364 articles, of which three met the eligibility criteria. These studies reported on the prevalence of leg ulceration, the number of Doppler assessments conducted for patients and the use of compression therapy. CONCLUSION: This review confirmed a lack of information on the prevalence of hospital inpatients with leg ulcers, and identified the need to conduct prevalence audits, establish leg ulcer services to streamline inpatient leg ulcer care and provide staff and patient education programmes.

Aetiological treatment of venous leg ulcers with compression therapy: real-life outcomes with two different procedures.

OBJECTIVE: To evaluate the healing outcomes and costs associated with the aetiological management of venous leg ulcers (VLUs) treated with recommended multicomponent bandages (MCBs) and short-stretch bandages (SSBs). METHOD: This observational study is a retrospective comparative study (Level 2b), based on the French administrative healthcare database (Système National des Données de Santé, SNDS). It includes patients treated from onset with reimbursed MCBs and SSBs for a VLU episode, between July 2018 and September 2020. Although other compression systems, such as long-stretch bandages, are commonly used for the treatment of VLUs, they are not recommended by health authorities in France and thus, were not considered for this study. A binomial regression model was performed to estimate the adjusted relative risk of wound closure rates at three months for each group, based on potential confounding factors including, notably, age, sex, key comorbidities, and wound dressing size. The mean healthcare cost was calculated for patients whose VLUs healed within the study period. RESULTS: The reimbursement data (including prescribed compression systems and nursing care) of the 25,255 selected patients were analysed in the study. There were no significant differences between the MCBs and SSBs groups when considering patient characteristics. The healing rates after three months' treatment, were 42% and 35% (p<0.001) in the MCBs and SSBs groups, respectively. When adjusting the statistical model, the chance of healing at three months was still 12% higher with MCBs compared with SSBs (p<0.0001). The median healing time was estimated at 115 (interquartile range (IQR): 60-253) days in the MCB group versus 137 (IQR: 68-300) days in the SSBs group. The average treatment cost per patient with a healed ulcer was €2875±3647 in the MCB group and €3580±5575) in the SSBs group (p=0.0179), due to lower hospital stay and nursing costs in the MCB group. Differences in wound characteristics between the two groups cannot be totally excluded, due to the limited content of the database in terms of clinical data, but should have been addressed, to some extent, through the study selection criteria and the chosen regression model. CONCLUSION: In this study, this SNDS analysis seemed to confirm that the healing outcomes achieved in real-life with MCBs were in line with those reported in clinical trials, and superior to SSBs, which reinforces the current position from the guidelines.

A Novel Randomized Trial Protocol for Evaluating Wound Healing Interventions.

Background: Randomized controlled trials using complete healing as an endpoint suffer from poor statistical power, owing to the heterogeneity of wounds and their healing trajectories. The Food and Drug Administration (FDA) has recently consulted with expert groups to consider percentage area reduction (PAR) of the wound over a 4-week period as a valid intermediate endpoint, creating the opportunity for more powerful study designs. Methods: A within-subject controlled study design comparing the PAR of venous leg ulcers (VLU) in patients over 4 weeks receiving different interventions. Twenty-nine patients received multilayer compression over 4 weeks, followed by neuromuscular electrostimulation (NMES) of the leg muscle pump in addition to compression for a further 4 weeks. Paired comparison was then made of PAR between the two phases. A second cohort of 22 patients received only multilayer compression throughout both 4-week phases. Results: Patients randomized to NMES saw a significant increase in healing rate compared with compression alone, whereas patients receiving compression only saw no significant change in healing rate throughout the course of the study. Conclusions: Intermittent NMES of the common peroneal nerve significantly accelerates the healing of VLU. It is well tolerated by patients and deserves serious consideration as an adjuvant to compression therapy. PAR is a useful metric for comparing the performance of wound healing interventions, and the self-controlled trial design allows sensitive discrimination with a relatively small number of subjects over a reasonably short trial period. The study is reported according to the CONSORT reporting guidelines. Clinical Trial Registration: NCT03396731 (ClinicalTrials.gov).

Compression therapy in dermatology.

Compression therapy is a conservative therapy that can be used in many patients with dermatological conditions, especially those associated with edema. In addition to its well-established use in venous and lymphatic disorders, there is increasing evidence that compression therapy supports the healing of inflammatory dermatoses. The presence of edema, regardless of its etiology, is an indication for the use of compression therapy. Nowadays, a variety of materials and treatment options are available for compression therapy, each with their own advantages and disadvantages. Often, compression therapy with low resting pressures is sufficient for effective therapy and is better tolerated by patients. The main contraindications to compression therapy are advanced peripheral arterial disease and decompensated heart failure. Individual factors and economic considerations should be taken into account when deciding on compression therapy with the patient. Patient self-management should be encouraged whenever possible. This requires education and support tools.

Assessing the healthcare costs associated with venous leg ulcer compression bandages - A scoping review.

AIM: To determine the monetary costs identified in economic evaluations of treatment with compression bandages among adults with venous leg ulcers (VLU). METHOD: A scoping review of existing publications was conducted in February 2023. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were used. RESULTS: Ten studies met the inclusion criteria. To place the costs of treatment into context, these are reported in conjunction with the healing rates. Three comparisons were made: 1.4 layer compression versus no compression (3 studies). One study reported that 4 layer compression was more expensive than usual care (£804.03 vs £681.04, respectively), while the 2 other studies reported the converse (£145 vs £162, respectively) and all costs (£116.87 vs £240.28 respectively). Within the three studies, the odds of healing were statistically significantly greater with 4 layer bandaging (OR: 2.20; 95% CI: 1.54-3.15; p = 0.001).; 2.4 layer compression versus other compression (6 studies). For the three studies reporting the mean costs per patient associated with treatment (bandages alone), over the treatment period, analysis identified a mean difference (MD) in costs for 4 layer vs comparator 1 (2 layer compression, short-stretch compression, 2 layer compression hosiery, 2 layer cohesive compression, 2 layer compression) of -41.60 (95% CI: 91.40 to 8.20; p = 0.10). The OR of healing for 4 layer compression vs comparator 1 (2 layer compression, short-stretch compression, 2 layer compression hosiery, 2 layer cohesive compression, 2 layer compression) is: 0.70 (95% CI: 0.57-0.85; p = 0.004). For 4 layer vs comparator 2 (2 layer compression) the MD is: 14.00 (95% CI: 53.66 to -25.66; p < 0.49). The OR of healing for 4 layer compression vs comparator 2 (2 layer compression) is: 3.26 (95% CI: 2.54-4.18; p < 0.00001). For comparator 1 (2 layer compression, short-stretch compression, 2 layer compression hosiery, 2 layer cohesive compression, 2 layer compression) vs comparator 2 (2 layer compression) the MD in costs is: 55.60 (95% CI: 95.26 to -15.94; p = 0.006). The OR of healing with Comparator 1 (2 layer compression, short-stretch compression, 2 layer compression hosiery, 2 layer cohesive compression, 2 layer compression) is: 5.03 (95% CI:4.10-6.17; p < 0.00001). Three studies presented the mean annual costs per patient associated with treatment (all costs). The MD is 172 (150-194; p = 0.401), indicating no statistically significant difference in costs between the groups. All studies showed faster healing rates in the 4 layer study groups. 3. Compression wrap versus inelastic bandage (one study). Compression wrap was less expensive than inelastic bandage (£201 vs £335, respectively) with more wounds healing in the compression wrap group (78.8%, n = 26/33; 69.7%, n = 23/33). CONCLUSION: The results for the analysis of costs varied across the included studies. As with the primary outcome, the results indicated that the costs of compression therapy are inconsistent. Given the methodological heterogeneity among studies, future studies in this area are needed and these should use specific methodological guidelines to generate high-quality health economic studies.