Lowering the Acquisition of Multi-drug Resistant Organism (MDROs) with Pulsed-xenon (LAMP) Study: a cluster randomized controlled, double-blinded, interventional crossover trial.

BACKGROUND: Environmental disinfection is essential for reducing spread of healthcare associated infections (HAIs). Previous studies report conflicting results regarding the effects of ultraviolet light (UV) in reducing infections. This trial evaluated the impact of adding pulsed xenon UV (PX-UV) to standard terminal cleaning in reducing environmentally-implicated HAIs (eiHAIs). METHODS: The LAMP trial was conducted in 2 hospitals (15 inpatient wards) utilizing a cluster randomized controlled, double-blinded, interventional crossover trial comparing standard terminal cleaning followed by either pulsed xenon ultraviolet (PX-UV) disinfection (intervention arm) or sham disinfection (control arm). The primary outcome was incidence of eiHAIs from clinical microbiology tests on the 4th day of stay or later or within 3 days after discharge from the study unit. EiHAIs included clinical cultures positive for vancomycin-resistant enterococci (VRE), extended spectrum beta-lactamase-producing Escherichia coli or Klebsiella pneumonia, methicillin-resistant Staphylococcus aureus (MRSA), and Acinetobacter baumannii, and stool PCR positive for Clostridiodes difficile. FINDINGS: Between May 18, 2017 to Jan 7, 2020, 25,732 patients were included, with an incidence of 601 eiHAI and 180,954 patient days. There was no difference in the rate of eiHAIs in the intervention and sham arms (3.49 vs 3.17 infections/1000 patient days respectively, RR 1.10 CI (0.94, 1.29, p= 0.23)). Study results were similar when stratified by eiHAI type, hospital, and unit type. CONCLUSION: The LAMP study failed to demonstrate an effect of the addition of UV light disinfection following terminal cleaning on reductions in rates of eiHAIs. Further investigations targeting hospital environmental surfaces and the role of no touch technology to reduce HAIs are needed.

A purified reconstituted bilayer matrix shows improved outcomes in treatment of non-healing diabetic foot ulcers when compared to the standard of care: Final results and analysis of a prospective, randomized, controlled, multi-centre clinical trial.

As the incidence of diabetic foot ulcers (DFU) increases, better treatments that improve healing should reduce complications of these ulcers including infections and amputations. We conducted a randomized controlled trial comparing outcomes between a novel purified reconstituted bilayer membrane (PRBM) to the standard of care (SOC) in the treatment of non-healing DFUs. This study included 105 patients who were randomized to either of two treatment groups (n = 54 PRBM; n = 51 SOC) in the intent to treat (ITT) group and 80 who completed the study per protocol (PP) (n = 47 PRBM; n = 33 SOC). The primary endpoint was the percentage of wounds closed after 12 weeks. Secondary outcomes included percent area reduction, time to healing, quality of life, and cost to closure. The DFUs that had been treated with PRBM healed at a higher rate than those treated with SOC (ITT: 83% vs. 45%, p = 0.00004, PP: 92% vs. 67%, p = 0.005). Wounds treated with PRBM also healed significantly faster than those treated with SOC with a mean of 42 versus 62 days for SOC (p = 0.00074) and achieved a mean wound area reduction within 12 weeks of 94% versus 51% for SOC (p = 0.0023). There were no adverse events or serious adverse events that were related to either the PRBM or the SOC. In comparison to the SOC, DFUs healed faster when treated with PRBM. Thus, the use of this PRBM is an effective option for the treatment of chronic DFUs.

Counting the Cost of Cellular and/or Tissue-Based Products in Diabetic Foot Ulcers: Is There a Justifiable Price Limit per Square Centimeter?

Objective: To identify how cellular and/or tissue-based products (CTPs) relate to value in terms of cost per quality-adjusted life years (QALYs) in wound care in comparison with treatments in other medical fields. Approach: This is a cross-sectional study and a cost-effectiveness analysis. Payment limits for each CTP were obtained via the Healthcare Common Procedure Coding System Q codes and formulated as cost inputs into a cost-utility model published for treatment of Wagner 1 diabetic foot ulcers using dehydrated human amnion and chorion allograft versus standard of care (SOC). Additional changes to cap the number of CTP applications and adjustments for recent inflation were made. The literature was searched for other cost-utility models in other diabetes-related diseases as a comparison. Results: When the payment limit was ≤$140 per square centimeter, interventions were dominant (less costly, better outcomes) compared with SOC. When the limit exceeded $430 per square centimeter, the cost-effectiveness threshold of $100,000/QALY was exceeded. Newer Q codes are generally much more expensive and likely to not be cost-effective, similar to the results for many other chronic diabetes-related diseases . Innovation: This study presents decision makers with tools, by which they can determine as to whether a given CTP is likely to be cost-effective for patients. Conclusion: Over a third of all CTPs will very likely result in noncost-effective interventions. This number is likely to be higher when wounds are larger or used in other wound types where they are less efficacious. The recent trend in much higher costs for CTPs is worrisome.

Better Wound Care Begins With Better Evidence: Outcomes of the Wound Care Evidence Summit.

In 2022, the Alliance of Wound Care Stakeholders convened the 2-day Wound Care Evidence Summit™. The Summit brought together a multidisciplinary group of stakeholders that included payers, government agency policymakers, prominent researchers, wound care medical specialty societies, patient and clinical associations, wound care clinics, and manufacturers to discuss wound care evidence and coverage issues. The Summit focused on a wide variety of wound care topics, with an emphasis on the processes payers use to create their coverage policies and the type, quantity, and characteristics of clinical evidence payers require. The most valuable outcome of the Summit was the frank and open discourse among stakeholders, with unprecedented participation from payers and the U.S. Food and Drug Administration (FDA) on the subjects of trial design, product-approval pathways, and coverage policy determination. Stakeholders provided actionable ideas for ways to improve clinical trial research and design that will yield better evidence and ultimately better wound care. This article examines the quality, adequacy, and relevance of the existing chronic wound care research base and discusses the gaps, associated problems, and implications for clinical trial design and execution as identified by Summit participants.

PEG hydrogel sealant versus fibrin glue in posterior fossa surgery: an economic comparison across five European countries.

Aim: Posterior cranial fossa (PCF) surgery is associated with complications, including cerebrospinal fluid (CSF) leakage. Dural sealants such as polyethylene glycol (PEG)-based hydrogels and fibrin glue can prevent CSF leaks, with evidence suggesting PEG hydrogels may outperform fibrin glue. However, the budget impact of using PEG hydrogels in PCF surgeries in Europe is unclear. Materials & methods: A decision tree was developed based on a previous US model, to assess the budget impact of switching from fibrin glue to PEG hydrogel in PCF surgery across five European countries. Input costs were derived from published sources for the financial year 2022/2023. Health outcomes, including CSF leaks, were considered. Results: The model predicted that using PEG hydrogel instead of fibrin glue in PCF surgery can lead to cost savings in five European countries. Cost savings per patient ranged from EUR 419 to EUR 1279, depending on the country. Sensitivity analysis showed that the incidence of CSF leaks and pseudomeningoceles had a substantial impact on the model's results. Conclusion: PEG hydrogels may be a cost-effective alternative to fibrin glue in PCF surgery. The model predicted that cost savings would be mainly driven by a reduction in the incidence of postoperative CSF leaks, resulting in reduced reliance on lumbar drains, reparative surgery and shortened hospital stays.

Complexities and challenges of surgical data collection from cataract patients: comparison of cataract surgery rates between 2001 and 2008 in all provinces of Argentina / Complexidades e desafios da coleta de dados cirúrgicos de catarata: comparação das taxas de cirurgia de catarata em todas as províncias da Argentina de 2001 em relação a 2008

Purpose: To compare the cataract surgical rate (CSR) in 2001 with that in 2008 in all Argentinean provinces using current reporting methods and verify the accuracy of CSRs by crosschecking these methods with the number of sold intraocular lenses (IOLs) within the country. Methods: A longitudinal study including public and private setups was conducted, and it included 40 ophthalmologists from 22 provinces who provided cataract surgery data for 2001 and 2008. Other data were obtained from the Ministry of Health. Estimates were crosschecked against the market data for sold intraocular lens (IOLs) in 2008 and 2010. Results: The number of cataract surgeries increased 2.7-fold, from 62,739 in 2001 to 169,762 in 2008, with increases in every province except Mendoza. Although the population also increased by 9.4% during the same time period, the apparent CSR jumped from 1,744 to 4,313 per million population. The number of IOLs sold in Argentina in 2008 was 186,652, suggesting that the number of cataract surgeries performed was slightly greater than anticipated. Crosschecks with other countries using IOL sales data did not show discrepancies when compared with previously reported CSRs. Conclusions: Although the CSR in Argentina increased considerably from 2001 to 2008 for several reasons, the main reason was that thorough crosschecking between the number of surgeries reported and the number of IOLs sold revealed that the number of surgeries performed annually were being underestimated as a result of incomplete reporting by private practitioners. Furthermore, the presence of multiple societies of ophthalmology in the country complicated the process of obtaining accurate data. .

Objetivo: Comparar a taxa de cirurgia de catarata (TCC) em todas as províncias da Argentina entre 2001 e 2008, utilizando métodos de relatórios convencionais e verificar a precisão da TCC por meio do cruzamento desses métodos com o número de lentes intraoculares (LIOs) vendidas no país. Métodos: Estudo longitudinal realizado em clínicas públicas e privadas, com a participação de 40 oftalmologistas de 22 províncias, que forneceram dados sobre cirurgias de catarata para 2001 e 2008. Outros dados foram obtidos a partir do Ministério da Saúde. As observações foram cruzadas com os dados de mercado para LIOs no período de 2008 a 2010. Resultados: O número de cirurgias de catarata aumentaram 2,7 vezes, de 62.739 em 2001 para 169.762 em 2008, com aumentos em todas as províncias, exceto Mendoza. Embora a população também tenha aumentado 9,4 % durante o mesmo período de tempo, a aparente TCC saltou de 1.744 para 4.313 por milhão de população. O número de LIOs vendidas na Argentina em 2008 foi de 186.652, o que pode significar que tenham sido realizadas um pouco mais de cirurgias de catarata do que o estimado. Verificações cruzadas com outros países que utilizam dados de vendas de LIOs não apresentam discrepâncias quando comparado a TCC anteriormente relatadas. Conclusões: De 2001 a 2008, a TCC na Argentina aumentou consideravelmente por várias razões mas, principalmente, porque foi revelada, por meio do cruzamento de dados sobre cirurgias relatadas com o número de LIOs vendidas, que o número de cirurgias realizadas anualmente foi hipoestimado no passado, como resultado de relatórios incompletos feitos por médicos privados. Há também várias sociedades de oftalmologia no país, o que dificulta a obtenção de dados precisos. .