Cost-effectiveness of Compression Therapy With Early Endovenous Ablation in Venous Ulceration for a Medicare Population.

Importance: Venous leg ulcers (VLU) are the most common cause of lower extremity ulceration that commonly occur among older individuals and are characterized by a slow healing trajectory and frequent recurrence; in the United States, VLUs affect more than 600 000 people per year with an estimated cost of $3.5 billion. Clinical trial data show that early intervention with endovenous ablation substantially improves the healing rate and reduces recurrence among patients with VLUs, but there is a need to assess the cost-effectiveness of early endovenous ablation in the US context. Objectives: To evaluate the cost-effectiveness of early endovenous ablation of superficial venous reflux in patients with VLU from the US Medicare perspective. Design, Setting, and Participants: This economic evaluation used a Markov model to simulate the disease progression of VLU for patients receiving compression therapy with early vs deferred ablation over 3 years. The simulated cohort included patients with VLU aged 65 years and older who had clinical characteristics similar to those in the randomized Early Venous Reflux Ablation trial in the United Kingdom. Data were analyzed from September 2021 to June 2022. Main Outcomes and Measures: Direct medical costs, quality-adjusted life years (QALYs), and the incremental monetary benefits at a willingness-to-pay threshold of $100 000/QALY. Univariate and probabilistic sensitivity analyses were performed to test uncertainty of model results. Results: This model used a simulated cohort of patients with VLU aged 65 years and older enrolled in Medicare. Early ablation dominated, with a lower per-patient cost of $12 527 and an increase of 2.011 QALYs, whereas compression therapy with deferred ablation yielded a per-patient cost of $15 208 and 1.985 QALYs gained. At a $100 000/QALY cost-effectiveness threshold, the incremental net monetary benefit was $5226 per patient in favor of early ablation. Probability of healing, followed by the probability of recurrence, was the parameter with greatest impact on model uncertainty. The probabilistic sensitivity analysis showed that early ablation was cost-effective in 59.2% of simulations at the $100 000/QALY threshold. Conclusions and Relevance: In this economic evaluation of compression therapy with early endovenous ablation, early intervention was dominant, as it was cost saving and generated greater QALYs over 3 years from the US Medicare perspective. Payers should prioritize coverage for early ablation to prevent VLU complications rather than treat a costly outcome that also reduces patient well-being.

Long-term Clinical and Cost-effectiveness of Early Endovenous Ablation in Venous Ulceration: A Randomized Clinical Trial.

Importance: One-year outcomes from the Early Venous Reflux Ablation (EVRA) randomized trial showed accelerated venous leg ulcer healing and greater ulcer-free time for participants who are treated with early endovenous ablation of lower extremity superficial reflux. Objective: To evaluate the clinical and cost-effectiveness of early endovenous ablation of superficial venous reflux in patients with venous leg ulceration. Design, Setting, and Participants: Between October 24, 2013, and September 27, 2016, the EVRA randomized clinical trial enrolled 450 participants (450 legs) with venous leg ulceration of less than 6 months' duration and superficial venous reflux. Initially, 6555 patients were assessed for eligibility, and 6105 were excluded for reasons including ulcer duration greater than 6 months, healed ulcer by the time of randomization, deep venous occlusive disease, and insufficient superficial venous reflux to warrant ablation therapy, among others. A total of 426 of 450 participants (94.7%) from the vascular surgery departments of 20 hospitals in the United Kingdom were included in the analysis for ulcer recurrence. Surgeons, participants, and follow-up assessors were not blinded to the treatment group. Data were analyzed from August 11 to November 4, 2019. Interventions: Patients were randomly assigned to receive compression therapy with early endovenous ablation within 2 weeks of randomization (early intervention, n = 224) or compression with deferred endovenous treatment of superficial venous reflux (deferred intervention, n = 226). Endovenous modality and strategy were left to the preference of the treating clinical team. Main Outcomes and Measures: The primary outcome for the extended phase was time to first ulcer recurrence. Secondary outcomes included ulcer recurrence rate and cost-effectiveness. Results: The early-intervention group consisted of 224 participants (mean [SD] age, 67.0 [15.5] years; 127 men [56.7%]; 206 White participants [92%]). The deferred-intervention group consisted of 226 participants (mean [SD] age, 68.9 [14.0] years; 120 men [53.1%]; 208 White participants [92%]). Of the 426 participants whose leg ulcer had healed, 121 (28.4%) experienced at least 1 recurrence during follow-up. There was no clear difference in time to first ulcer recurrence between the 2 groups (hazard ratio, 0.82; 95% CI, 0.57-1.17; P = .28). Ulcers recurred at a lower rate of 0.11 per person-year in the early-intervention group compared with 0.16 per person-year in the deferred-intervention group (incidence rate ratio, 0.658; 95% CI, 0.480-0.898; P = .003). Time to ulcer healing was shorter in the early-intervention group for primary ulcers (hazard ratio, 1.36; 95% CI, 1.12-1.64; P = .002). At 3 years, early intervention was 91.6% likely to be cost-effective at a willingness to pay of £20 000 ($26 283) per quality-adjusted life year and 90.8% likely at a threshold of £35 000 ($45 995) per quality-adjusted life year. Conclusions and Relevance: Early endovenous ablation of superficial venous reflux was highly likely to be cost-effective over a 3-year horizon compared with deferred intervention. Early intervention accelerated the healing of venous leg ulcers and reduced the overall incidence of ulcer recurrence. Trial Registration: ClinicalTrials.gov identifier: ISRCTN02335796.

Early versus deferred endovenous ablation of superficial venous reflux in patients with venous ulceration: the EVRA RCT.

BACKGROUND: Venous ulceration is a common and costly health-care issue worldwide, with poor healing rates greatly affecting patient quality of life. Compression bandaging has been shown to improve healing rates and reduce recurrence, but does not address the underlying cause, which is often superficial venous reflux. Surgical correction of the reflux reduces ulcer recurrence; however, the effect of early endovenous ablation of superficial venous reflux on ulcer healing is unclear. OBJECTIVES: To determine the clinical effectiveness and cost-effectiveness of compression therapy with early endovenous ablation of superficial venous reflux compared with compression therapy with deferred endovenous ablation in patients with venous ulceration. DESIGN: A pragmatic, two-arm, multicentre, parallel-group, open randomised controlled trial with a health economic evaluation. SETTING: Secondary care vascular centres in England. PARTICIPANTS: Patients aged ≥ 18 years with a venous leg ulcer of between 6 weeks' and 6 months' duration and an ankle-brachial pressure index of ≥ 0.8 who could tolerate compression and were deemed suitable for endovenous ablation of superficial venous reflux. INTERVENTIONS: Participants were randomised 1 : 1 to either early ablation (compression therapy and superficial endovenous ablation within 2 weeks of randomisation) or deferred ablation (compression therapy followed by endovenous ablation once the ulcer had healed). MAIN OUTCOME MEASURES: The primary outcome measure was time from randomisation to ulcer healing, confirmed by blinded assessment. Secondary outcomes included 24-week ulcer healing rates, ulcer-free time, clinical success (in addition to quality of life), costs and quality-adjusted life-years (QALYs). All analyses were performed on an intention-to-treat basis. RESULTS: A total of 450 participants were recruited (224 to early and 226 to deferred superficial endovenous ablation). Baseline characteristics were similar between the two groups. Time to ulcer healing was shorter in participants randomised to early superficial endovenous ablation than in those randomised to deferred ablation [hazard ratio 1.38, 95% confidence interval (CI) 1.13 to 1.68; p = 0.001]. Median time to ulcer healing was 56 (95% CI 49 to 66) days in the early ablation group and 82 (95% CI 69 to 92) days in the deferred ablation group. The ulcer healing rate at 24 weeks was 85.6% in the early ablation group, compared with 76.3% in the deferred ablation group. Median ulcer-free time was 306 [interquartile range (IQR) 240-328] days in the early ablation group and 278 (IQR 175-324) days in the deferred endovenous ablation group (p = 0.002). The most common complications of superficial endovenous ablation were pain and deep-vein thrombosis. Differences in repeated measures of Aberdeen Varicose Vein Questionnaire scores (p < 0.001), EuroQol-5 Dimensions index values (p = 0.03) and Short Form questionnaire-36 items body pain (p = 0.05) over the follow-up period were observed, in favour of early ablation. The mean difference in total costs between the early ablation and deferred ablation groups was £163 [standard error (SE) £318; p = 0.607]; however, there was a substantial and statistically significant gain in QALY over 1 year [mean difference between groups 0.041 (SE 0.017) QALYs; p = 0.017]. The incremental cost-effectiveness ratio of early ablation at 1 year was £3976 per QALY, with a high probability (89%) of being more cost-effective than deferred ablation at conventional UK decision-making thresholds (currently £20,000 per QALY). Sensitivity analyses using alternative statistical models give qualitatively similar results. LIMITATIONS: Only 7% of screened patients were recruited, treatment regimens varied significantly and technical success was assessed only in the early ablation group. CONCLUSIONS: Early endovenous ablation of superficial venous reflux, in addition to compression therapy and wound dressings, reduces the time to healing of venous leg ulcers, increases ulcer-free time and is highly likely to be cost-effective. FUTURE WORK: Longer-term follow-up is ongoing and will determine if early ablation will affect recurrence rates in the medium and long term. TRIAL REGISTRATION: Current Controlled Trials ISRCTN02335796. 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. 23, No. 24. See the NIHR Journals Library website for further project information.

Venous leg ulcers are open wounds occurring on the legs of patients with venous disease. They are common, painful and distressing and reduce patient quality of life. Leg ulcers often result from valves in the leg veins not working properly. The valves normally force blood back up towards the heart; however, blood can flow backwards (reflux) when valves do not work properly, and this can cause swelling and ulceration. Compression therapy (wrapping bandages around the legs) has been shown to help ulcers heal, but it does not treat the underlying reflux problem with the veins. Newer, less invasive, techniques (known as endovenous ablation) have taken over from surgery to correct venous reflux and are more acceptable to patients as they can be performed quickly under local anaesthetic. The aim of the trial was to find out if treating patients with leg ulcers by early endovenous ablation (within 2 weeks) and standard compression therapy can increase ulcer healing compared with standard compression therapy and delayed endovenous ablation once the ulcer has healed. In total, 450 people agreed to take part in this study and were treated in 20 hospitals across England. Participants were randomly allocated to either early or delayed endovenous ablation and followed up for 12 months. The trial found that treating the veins early resulted in quicker ulcer healing than delaying treatment until the ulcer had healed. The trial also showed that participants had more time without an ulcer if the treatment was performed early rather than after ulcer healing. No safety issues with early intervention were identified. There is some evidence that quality of life was better in the early treatment group and that people in this group had less body pain. Treating ulcers early appears likely to be more cost-effective (i.e. a better use of NHS resources) than delayed treatment. Future work will focus on collecting longer-term follow-up data to find out if early endovenous ablation also reduces the chances of the ulcer coming back.

Cost-effectiveness analysis of a randomized clinical trial of early versus deferred endovenous ablation of superficial venous reflux in patients with venous ulceration.

BACKGROUND: Treatment of superficial venous reflux in addition to compression therapy accelerates venous leg ulcer healing and reduces ulcer recurrence. The aim of this study was to evaluate the costs and cost-effectiveness of early versus delayed endovenous treatment of patients with venous leg ulcers. METHODS: This was a within-trial cost-utility analysis with a 1-year time horizon using data from the EVRA (Early Venous Reflux Ablation) trial. The study compared early versus deferred endovenous ablation for superficial venous truncal reflux in patients with a venous leg ulcer. The outcome measure was the cost per quality-adjusted life-year (QALY) over 1 year. Sensitivity analyses were conducted with alternative methods of handling missing data, alternative preference weights for health-related quality of life, and per protocol. RESULTS: After early intervention, the mean(s.e.m.) cost was higher (difference in cost per patient £163(318) (€184(358))) and early intervention was associated with more QALYs at 1 year (mean(s.e.m.) difference 0·041(0·017)). The incremental cost-effectiveness ratio (ICER) was £3976 (€4482) per QALY. There was an 89 per cent probability that early venous intervention is cost-effective at a threshold of £20 000 (€22 546)/QALY. Sensitivity analyses produced similar results, confirming that early treatment of superficial reflux is highly likely to be cost-effective. CONCLUSION: Early treatment of superficial reflux is highly likely to be cost-effective in patients with venous leg ulcers over 1 year. Registration number: ISRCTN02335796 (http://www.isrctn.com).

A Randomized Trial of Early Endovenous Ablation in Venous Ulceration.

BACKGROUND: Venous disease is the most common cause of leg ulceration. Although compression therapy improves venous ulcer healing, it does not treat the underlying causes of venous hypertension. Treatment of superficial venous reflux has been shown to reduce the rate of ulcer recurrence, but the effect of early endovenous ablation of superficial venous reflux on ulcer healing remains unclear. METHODS: In a trial conducted at 20 centers in the United Kingdom, we randomly assigned 450 patients with venous leg ulcers to receive compression therapy and undergo early endovenous ablation of superficial venous reflux within 2 weeks after randomization (early-intervention group) or to receive compression therapy alone, with consideration of endovenous ablation deferred until after the ulcer was healed or until 6 months after randomization if the ulcer was unhealed (deferred-intervention group). The primary outcome was the time to ulcer healing. Secondary outcomes were the rate of ulcer healing at 24 weeks, the rate of ulcer recurrence, the length of time free from ulcers (ulcer-free time) during the first year after randomization, and patient-reported health-related quality of life. RESULTS: Patient and clinical characteristics at baseline were similar in the two treatment groups. The time to ulcer healing was shorter in the early-intervention group than in the deferred-intervention group; more patients had healed ulcers with early intervention (hazard ratio for ulcer healing, 1.38; 95% confidence interval [CI], 1.13 to 1.68; P=0.001). The median time to ulcer healing was 56 days (95% CI, 49 to 66) in the early-intervention group and 82 days (95% CI, 69 to 92) in the deferred-intervention group. The rate of ulcer healing at 24 weeks was 85.6% in the early-intervention group and 76.3% in the deferred-intervention group. The median ulcer-free time during the first year after trial enrollment was 306 days (interquartile range, 240 to 328) in the early-intervention group and 278 days (interquartile range, 175 to 324) in the deferred-intervention group (P=0.002). The most common procedural complications of endovenous ablation were pain and deep-vein thrombosis. CONCLUSIONS: Early endovenous ablation of superficial venous reflux resulted in faster healing of venous leg ulcers and more time free from ulcers than deferred endovenous ablation. (Funded by the National Institute for Health Research Health Technology Assessment Program; EVRA Current Controlled Trials number, ISRCTN02335796 .).

Cost analysis of negative-pressure wound therapy with instillation for wound bed preparation preceding split-thickness skin grafts for massive (>100 cm(2)) chronic venous leg ulcers.

OBJECTIVE: Massive (≥100 cm(2)) venous leg ulcers (VLUs) demonstrate very low closure rates with standard compression therapy and are costly to manage. Negative-pressure wound therapy (NPWT), followed by a split-thickness skin graft (STSG), can be a cost-effective alternative to this standard care. We performed a cost analysis of these two treatments. METHODS: A retrospective review was performed of 10 ulcers treated with surgical debridement, 7 days of inpatient NPWT with topical antiseptic instillation (NPWTi), and STSG, with 4 additional days of inpatient NPWT bolster over the graft. Independent medical cost estimators were used to compare the cost of this treatment protocol with standard outpatient compression therapy. RESULTS: The average length of time ulcers were present before patients entered the study was 38 months (range, 3-120 months). Eight of 10 patients had complete VLU closure by 6 months after NPWTi with STSG. The 6-month costs of the proposed treatment protocol and standard twice-weekly compression therapy were estimated to be $27,000 and $28,000, respectively. CONCLUSIONS: NPWTi with STSG treatment is more effective for closure of massive VLUs at 6 months than that reported for standard compression therapy. Further, the cost of the proposed treatment protocol is comparable with standard compression therapy.

Comparison of outcomes in patients with venous leg ulcers treated with compression therapy alone versus combination of surgery and compression therapy: a systematic review.

BACKGROUND: Venous leg ulcers (VLUs) are the most prevalent type of lower extremity ulcers and can be difficult to manage. Clinicians are challenged to provide care and recommendations that promote timely healing, minimize the risk of recurrence, and are cost-effective. Compression therapy is generally considered the primary intervention for both ulcer management and prevention of recurrence. However, recent studies suggest that surgical correction of venous insufficiency may enhance healing of venous ulcers or help prevent recurrence. PURPOSE: The objective of this systematic review was to compare wound healing and recurrence rates in patients managed with compression therapy alone versus compression therapy plus surgery. SEARCH STRATEGY: The author conducted a literature review selecting primary studies published between 2002 and 2012, using the electronic databases MEDLINE/PubMed and CINAHL/EBSCOhost. The following key words were applied: leg ulcer; varicose ulcer; bandage; "stockings, compression," venous ulceration; venous ulcer; compressive therapy; compression therapy; stocking; venous surgery. Inclusion criteria included randomized controlled trials that compared VLU healing rates and recurrence rates among patients receiving compression therapy alone, and patients receiving both compression therapy and surgical intervention to correct venous incompetence. Studies published in English, Spanish, or Portuguese were included. RESULTS: Sixty-seven studies were retrieved and 4 were identified that met inclusion criteria. In 3 of the studies, researchers reported no differences in healing rates for patients managed with compression plus surgery when compared to patients managed with compression alone. One study reported higher healing rates in the surgical group. Most studies revealed lower recurrence rates in patients who were managed with surgery plus compression, but these differences were not statistically significant. CONCLUSIONS: Existing evidence supports compression therapy as the most critical element in the management of venous leg ulcers. However, evidence also suggests that surgical obliteration of incompetent perforator veins may promote longer ulcerfree periods and lower rates of recurrence.

Tratamento da úlcera varicosa dos membros inferiores mediante cirurgia e bota de Unna: uma economia para o sistema de saúde brasileiro / Treatment of varicose ulcer of the lower limbs by surgery and Unna boot: savings for the Brazilian healthcare system

Objective: To perform an analysis of the costs of treatment of varicose ulcers by radical surgery of varices and the use of Unna boot. Methods: Fifteen outpatients were selected to receive treatment of varicose ulcers with radical surgery and Unna boot. The total cost of treatment was calculated (hospitalization, surgery, dressings, and outpatient?s follow-up visits) and compared to the cost of clinical follow-up with daily simple dressing changes. Results: The proposed treatment was on average 55.71% more economical than the management with daily dressings (approximately US$452.32 versus US$1,021.39). Conclusion: Radical varicose vein surgery associated with the useof the Unna boot proved meaningly less expensive for the public health system than clinical follow-up with daily dressings.

Objetivo: Realizar uma análise de custo do tratamento da úlcera varicosa mediante cirurgia radical de varizes e uso de bota de Unna. Métodos: quinze pacientes foram selecionados ambulatorialmente para receber o tratamento da úlcera varicosa com cirurgia radical de varizes e bota de Unna, sendo o custo total do tratamento contabilizado (internação, cirurgia, curativos e retornos ambulatoriais) e comparado ao custo do acompanhamento clínico com curativos simples trocados diariamente. Resultados: O tratamento proposto foi em média 55,71% mais econômico que o manejo com curativos diários (R$ 717,84 x R$ 1.620,95 ou aproximadamente US$ 452.32 x US$ 1,021.39). Conclusão: O emprego da cirurgia radical de varizes associado ao uso de bota de Unna provou-se expressivamente menos dispendioso para a saúde pública do que o acompanhamento clínico com curativos diários.

[Cost-benefit analysis of amniotic membrane transplantation for venous ulcers of the legs that are refractory to conventional treatment]. / Estudio coste-beneficio del trasplante de membrana amniótica para úlceras venosas de extremidades inferiores refractarias a tratamiento convencional.

BACKGROUND: Standard compression therapy for venous ulcers of the legs does not promote healing. Although autografting accelerates tissue repair, it is difficult to use in patients with concomitant diseases or when multiple grafts are required. The amniotic membrane has been used as a covering material and promotes epithelialization, making it a good potential treatment option when autografts are not indicated. OBJECTIVES: To analyze the literature on the safety and efficacy of amniotic membrane grafting and compare the cost of currently available grafts (autografts, amniotic membrane grafts, and biocompatible skin substitutes) to promote tissue repair in venous ulcers. MATERIAL AND METHODS: A systematic review of the literature on the use of amniotic membrane grafts for the treatment of venous ulcers was performed up to 2010. A cost-minimization analysis of direct healthcare costs was then performed (at 3 and 6 months). A sensitivity analysis was performed to confirm the stability of the results. RESULTS: Only 1 study addressing safety and efficacy was identified. The cost-minimization analysis showed that autografts are always the least-expensive option (€ 1053 compared with € 1825 for amniotic membrane grafts and € 5767 for biocompatible skin grafts). At 6 months, however, amniotic membrane grafts would have cost € 6765 less than the use of biocompatible skin substitutes. CONCLUSIONS: Despite having excellent therapeutic potential for the re-epithelialization of venous ulcers that do not respond to conventional treatment, amniotic membrane transplant remains an experimental therapy. Autograft is the most efficient treatment but amniotic membrane graft is less expensive than the use of biocompatible skin substitutes.

[Correlation of risk factors and complications in the conventional surgery of varicose veins]. / Corelatii între factorii de risc si complicatii în chirurgia conventionala a bolii varicoase.

The primary varicose vein disease, a largely spread affection, constitutes a present challenge and a major health concern because of its increased prevalence and the high expenses of treatment and patient care. Due to the modern instruments, preoperative investigations and the increased understanding of the physiopathological mechanisms in the alteration of venous return, this objective can be achieved easier. Nevertheless, according to ananalytical retrospective observational study performed at the Surgery Clinic II, Cluj-Napoca, on 957 patients with varices of lower extremities, postoperative complications occur in 11 percent, due to additional costs and patients' negative social and professional consequences. Another study performed at the same clinic on 1066 patients with primary varicose disease reveals the high incidence of the risk factors (62%) and progressive complications (44%). Furthermore, the study shows that patients tend to seek help at late stages of disease, which requires a longer hospitalization period and implicitly higher costs of postoperative care and treatment. A correct sanitary education of the affected population would reduce the treatment expenses. In addition, a more efficiently control of the disease, the prevention of progressive complications incidents, and the adequate surgical procedure that prevent the postoperative complications, would also reduce the costs. Considering the high number of surgical interventions involved in varicose disease treatment, the results presented in this study are of great significance for both surgeons and the institutions that provide the funds for treatment. surgical procedure that prevent the postoperative complications, would also reduce the costs. Considering the high number of surgical interventions involved in varicose disease treatment, the results presented in this study are of great significance for both surgeons and the institutions that provide the funds for treatment.

Endovenous treatments for varicose veins--over-taking or over-rated?

OBJECTIVES: A variety of endovenous therapies for the treatment of superficial venous incompetence are currently available. The aim of this study was to evaluate the prevalence of endovenous techniques used by consultant vascular surgeons in the United Kingdom. METHODS: An anonymous online survey of 16 multiple choice questions relating to the nature and provision of treatment for varicose veins was devised. Consultant members of the Vascular Society of Great Britain and Ireland were invited to participate by email. RESULTS: A total of 108/352 (31%) surgeons completed the survey. The majority offered surgery as the first-line treatment for primary great saphenous vein (GSV) and small saphenous vein (SSV) incompetence (69% and 74%, respectively). Endovenous procedures were offered as first-line treatment by 32/108 (29.6%) for GSV reflux, 36/51 (70.6%) surgeons performed these under local anaesthetic and 21/51 (41.2%) were performed as an outpatient procedure. The most important factor influencing treatment decisions was considered to be patient preference by 77/108 (71.3%) surgeons, although 48/61 (78.7%) respondents were restricted by primary care trusts with regard to endovenous treatments, and 33/108 (30.6%) offered different treatments to private patients. CONCLUSION: Traditional surgery remains the most commonly offered treatment for patients with varicose veins. The provision of endovenous therapies varies greatly, and there are significant differences in local availability regarding these treatments.

Best practice for assessment of patients with varicose veins.

BACKGROUND: Varicose veins are a significant health problem which attract much medicolegal attention. Recent publications have suggested "best practice" regarding assessment of patients with varicose veins. A retrospective audit was performed comparing clinical practice in a New Zealand teaching hospital with suggested standards. METHODS: Clinic letters from 80 patients awaiting varicose vein surgery were reviewed. Data were collated regarding presenting problem, relevant medical history, clinical findings on examination, further investigations, and outcome. RESULTS: Presenting complaint was noted for 99% of patients but actual symptoms were only recorded for 41%. The degree of disability caused by varicose veins was documented for 33% and patient concerns in 4%. Half of the patients presented with leg ulcers but ankle-brachial indices (ABPIs) were only recorded in 26% of clinic letters. Duplex scanning was recommended prior to surgery for 69% of patients and hand held Doppler assessment of venous disease was recorded in 61% cases. Clinic letters did not specify the nature and extent of disease in 6% of cases, and although every patient was recommended for surgery, the exact procedure was specified in only 24%. Details of surgical risks and complications were only present in 20% of letters, and only 21% of patients received a printed information sheet. CONCLUSIONS: The quality of the data recorded in the clinic letters of fell below suggested standards for assessment of patients with varicose veins. Improving the documentation of patient assessment will allow better communication between providers of healthcare and make clinical errors less likely.

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 specialized wound care center: a 7-year experience at a tertiary care hospital.

Multidisciplinary wound care centers have proliferated as a result of an increasing need for care of nonhealing wounds. Information regarding types of wounds treated, length of treatment, compliance with treatment, and rates of healing was collected from a tertiary care hospital-based wound center over a 7-year period. Venous stasis ulcers were the most common type of wound treated (21%) and were also the most likely to heal. Pressure ulcers (20%), diabetic neuropathic ulcers (14%), ischemic ulcers (6%), and postsurgical wounds (6%) comprised the remainder of wounds treated. The success of treating wounds varied greatly with the wound's etiology. Despite the chronic nature of these wounds, most patients did not become long-term patients of the wound center. This study provides baseline outcome measures, which can serve as the basis for the comparison of treatment protocols and the development of prospective clinical trials.

[Cost-effectiveness in wound care]. / Kosteneffektivität in der Wundbehandlung.

INTRODUCTION: In Germany, treatment costs for pressure ulcer, diabetic foot ulcer and ulcus cruris sum up to Euro 5 billion p. a. (cost of materials only). The question is to be answered how much money could be saved to sick funds, if the treatment is switched from traditional wound care, e. g. hydro-colloids to Vacuum Assisted Closure (V.A.C.). METHODS: Clinical studies are analysed with regard to complication rates and speed of wound healing V.A.C. vs. traditional. Daily costs and the length of treatment are then correlated and compared. RESULTS: V.A.C. therapy significantly reduces the time for the wound closing process, hospital admissions and complication rates. Despite higher daily treatment costs (cost of material, only), the V.A.C. therapy turns out to be the superior cost-effective method by far. Assumed V.A.C. therapy substitutes other methods by 50 %, sick funds could have saved Euro 0.7 billion p. a. DISCUSSION: The V.A.C. related saving potential is not available to sick funds because the approval process for home care use is still (Jan 2006) ongoing since 1999. The improvement of the relevant decision making process is strongly required to faster provide better care and savings at the same time.

Ulcera varicosa / It ulcerates varicose

Presenta estudio de procesos de enfermería en paciente con diagnóstico de Ulcera Varicosa miembro inferior derecho, en el servicio de Cirugía del Hospital Alfonso Moncada Guillén de Ocotal. El principal objetivo de este estudio es brindar atención con calidad, eficacia y equidad a la usuaria aplicando herramientas aprendidas durante el aprendizaje de las enfermeras. En la realización del trabajo se logro obtener una nueva experiencia de enriquecimiento de los conocimientos teóricos y prácticos en el quehacer profesional de las enfermeras, la aplicación de los cuidados a través de planes de cuidados obteniendo resultados positivos en la paciente durante su hospitalización. Se mencionan logros y se dan algunas recomendaciones...

Treatment of leg ulcers with split skin grafts: early and late results.

Sixty patients (mean age 73.5 years) with 88 leg ulcers that had not responded to conservative treatment had split skin grafts applied at the Department of Plastic Surgery, Linköping, Sweden. Of 51 venous leg ulcers 45 (88%) healed after a mean of 15 days (range 5-30); and 13 (62%) of the 21 arterial ulcers healed after a mean of 18 days (range 8-30). Additional skin grafting was done on nine of the venous and on three of the arterial ulcers. Twenty-two (49%) of the healed venous ulcers recurred after a mean of four months while only two (15%) of the healed arterial ulcers recurred after a mean of 10 months. At late follow up after a mean of four years 18 of the patients were dead and 10 had had the leg in question amputated. Of the 34 patients still alive who had not had amputations, 31 were investigated at open ward or interviewed by telephone and 23 patients were examined with colour duplex scan. Seven of these patients had open leg ulcers. At duplex scan six patients had no venous or arterial insufficiency that could cause a leg ulcer. Of 16 patients with venous insufficiency 10 patients had only an inadequate superficial system. The mean cost for treating one leg ulcer by skin grafting is estimated at SEK 89000 (US$11125). We conclude that leg ulcers often heal with skin grafting but that venous ulcers often recur. To reduce the recurrence rate we suggest a better preoperative aetiological evaluation and improved postoperative treatment with a compression bandage.