Browsing by Author "Gefen, Amit"
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- An international consensus on device-related pressure ulcers: SECURE preventionPublication . Gefen, Amit; Alves, Paulo; Ciprandi, Guido; Coyer, Fiona; Milne, Catherine; Ousey, Karen; Ohura, Norihiko; Waters, Nicola; Worsley, Peter
- Clinical and cost effectiveness of a system for turning and positioning intensive care unit patients, when compared to usual care turning and positioning devices, for the prevention of hospital-acquired pressure injuriesPublication . Kapp, Suzanne; Gerdtz, Marie; Gefen, Amit; Padula, William; Alves, Paulo; Trevellini, Chenel; Ghosh, Angaj; Shea, Ashley; Cross, Anthony; Sousa, Ines; Santamaria, NickPressure injuries affect 13.1% to 45.5% of patients in the intensive care unit and lead to pain and discomfort for patients, burden on healthcare providers, and unnecessary cost to the health system. Turning and positioning systems offer improvements on usual care devices, however the evidence of the effectiveness of such systems is still emerging. We conducted an investigator initiated, prospective, single centre, two group, non-blinded, randomised controlled trial to determine the effectiveness of a system for turning and positioning intensive care unit patients, when compared to usual care turning and positioning devices, for preventing PIs. The trial was prematurely discontinued after enrolment of 78 participants due to COVID-19 pandemic related challenges and lower than expected enrolment rate. The study groups were comparable on baseline characteristics and adherence to the interventions was high. Four participants developed a PI (in the sacral, ischial tuberosity or buttock region), n = 2 each in the intervention and control group. Each participant developed one PI. As the trial is underpowered, these findings do not provide an indication of the clinical effectiveness of the interventions. There was no participant drop-out or withdrawal and there were no adverse events, device deficiencies, or adverse device effects identified or reported. The results of our study (in particular those pertaining to enrolment, intervention adherence and safety) provide considerations for future trials that seek to investigate how to prevent PIs among ICU patients.
- Clinical performance characteristics for bordered foam dressings in the treatment of complex wounds: an international wound dressing technology expert panel reviewPublication . Santamaria, Nick; Woo, Kevin; Beeckman, Dimitri; Alves, Paulo; Cullen, Breda; Gefen, Amit; Lázaro-Martínez, José Luis; Lev-Tov, Hadar; Najafi, Bijan; Sharpe, Andrew; Swanson, TerryThe aim of this article is to identify and describe clinical practice performance characteristics for bordered foam dressings in the treatment of complex wounds. Our recently published systematic review of outcomes and applied measurement instruments for the use of bordered foam dressings in complex wounds has led to us identifying a range of important clinical and patient-centred issues related to this dressing class. Specifically, here, we focus on an overview of performance criteria in the areas of application, adhesion, exudate management and debridement functions of bordered foam dressings. Our hope is that by highlighting the clinical performance criteria, future testing standards for wound dressings will more closely match our clinical expectations and, thereby, assist clinicians to make better wound treatment choices based on meaningful and clinically relevant dressing product performance standards. complex wounds, complex wound care, treatment, bordered foam dressings, dressing performance.
- Device related pressure ulcers: SECURE preventionPublication . Gefen, Amit; Alves, Paulo; Ciprandi, Guido; Coyer, Fiona; Milne, Catherine T; Ousey, Karen; Ohura, Norihiko; Waters, Nicola; Worsley, Peter
- Fluid handling by foam wound dressings: from engineering theory to advanced laboratory performance evaluationsPublication . Gefen, Amit; Alves, Paulo; Beeckman, Dimitri; Cullen, Breda; Lázaro-Martínez, José Luis; Lev-Tov, Hadar; Santamaria, Nick; Swanson, Terry; Woo, Kevin; Söderström, Bengt; Svensby, Anna; Malone, Matthew; Nygren, ErikThis article describes the contemporary bioengineering theory and practice of evaluating the fluid handling performance of foam-based dressings, with focus on the important and clinically relevant engineering structure– function relationships and on advanced laboratory testing methods for preclinical quantitative assessments of this common type of wound dressings. The effects of key wound dressing material-related and treatment-related physical factors on the absorbency and overall fluid handling of foam-based dressings are thoroughly and quantitively analysed. Discussions include exudate viscosity and temperature, action of mechanical forces and the dressing microstructure and associated interactions. Based on this comprehensive review, we propose a newly developed testing method, experimental metrics and clinical benchmarks that are clinically relevant and can set the standard for robust fluid handling performance evaluations. The purpose of this evaluative framework is to translate the physical characteristics and performance determinants of a foam dressing into achievable best clinical outcomes. These guiding principles are key to distinguishing desirable properties of a dressing that contribute to optimal performance in clinical settings.
- How should clinical wound care and management translate to effective engineering standard testing requirements from foam dressings? Mapping the existing gaps and needsPublication . Gefen, Amit; Alves, Paulo; Beeckman, Dimitri; Cullen, Breda; Lázaro-Martínez, José Luis; Lev-Tov, Hadar; Najafi, Bijan; Santamaria, Nick; Sharpe, Andrew; Swanson, Terry; Woo, KevinSignificance: Wounds of all types remain one of the most important, expensive, and common medical problems, for example, up to approximately two-thirds of the work time of community nurses is spent on wound management. Many wounds are treated by means of dressings. The materials used in a dressing, their microarchitecture, and how they are composed and constructed form the basis for the laboratory and clinical performances of any advanced dressing. Recent Advances: The established structure/function principle in material science is reviewed and analyzed in this article in the context of wound dressings. This principle states that the microstructure determines the physical, mechanical, and fluid transport and handling properties, all of which are critically important for, and relevant to the, adequate performances of wound dressings. Critical Issues: According to the above principle, once the clinical requirements for wound care and management are defined for a given wound type and etiology, it should be theoretically possible to translate clinically relevant characteristics of dressings into physical test designs resulting specific metrics of materials, mechanical, and fluid transport and handling properties, all of which should be determined to meet the clinical objectives and be measurable through standardized bench testing. Future Directions: This multidisciplinary review article, written by an International Wound Dressing Technology Expert Panel, discusses the translation of clinical wound care and management into effective, basic engineering standard testing requirements from wound dressings with respect to material types, microarchitecture, and properties, to achieve the desirable performance in supporting healing and improving the quality of life of patients.
- Mechanical and contact characteristics of foam materials within wound dressings: theoretical and practical considerations in treatmentPublication . Gefen, Amit; Alves, Paulo; Beeckman, Dimitri; Lázaro-Martínez, José Luis; Lev-Tov, Hadar; Najafi, Bijan; Swanson, Terry; Woo, KevinIn the treatment of acute and chronic wounds, the clinical performance of a given foam-based dressing, and, ultimately, the wound healing and cost of care outcomes are strongly influenced by the mechanical performance of the foam material/s within that dressing. Most aspects of the mechanical performance of foam materials, for example, their stiffness, frictional properties, conformability, swelling characteristics and durability, and the overall mechanical protection provided by a foam-based dressing to a wound strongly depend on the microstructure of the foam components, particularly on their microtopography, density and porosity. This article, therefore, provides, for the first time, a comprehensive, self-inclusive compilation of clinically relevant theoretical and practical considerations, based on published analytical and experimental research as well as clinical experience related to the mechanical performance of foams in foam-based wound dressings. The current bioengineering information is useful for establishing understanding of the importance of mechanical properties of foams in foam-based dressings among clinicians and researchers in industry and academia, and other potential stakeholders in the wound care field, for example, regulators and buyers. This information is also particularly important for the development of standardised test methods for the evaluation of foam-based wound dressings and resulting standard mechanical performance metrics for these dressings.
- Meeting report: Are you doing everything possible to prevent pressure injury throughout the patient’s hospital stay?Publication . Harding, Keith; Black, Joyce; Gefen, Amit; Santamaria, Nick; Alves, Paulo; Ohura, Norihoko; Brindle, Tod; Trevellini, Chenel
- Meeting report: pressure injury prevention: clinical outcomes explained by robust scientific evidence: a panel discussionPublication . Alves, Paulo; Creehan, Sue; Gefen, Amit; Santamaria, Nick; Trevellini, ChenelThis meeting report summarises the proceedings of a panel-led symposium that took place at the European Wound Management Association (EWMA) Conference,Amsterdam in May 2017. It looks at the crucial role of pressure injury prevention and the importance of robust clinical data in proving the positive impact — for patients, clinicians and the healthcare economy — of implementing strategies that include the use of prophylactic dressings, positioners, and turning and positioning systems. The expert panel provided guidance on how to implement changes in line with evidence-based consensus, and highlighted the importance of delivering optimal care to at-risk patients.
- Prevention and management of pressure injury to the heelPublication . Black, Joyce; Santamaria, Nick; Gefen, Amit; Brindle, Tod; Fletcher, Jacqui; Alves, PauloPressure injuries on the heels often occur in immobile patients. The risk factors for these injuries stem from the anatomy of the calcaneus, impairments in blood flow to the foot and neuropathic disease. There are many clinical considerations in the prevention of heel pressure injury. This article addresses the epidemiology and economic impact of heel injury, identifies risk factors and differential diagnosis of their development, discusses challenges in prevention across the continuum of care, and provides guidance for selecting appropriate interventions in the prevention of heel pressure injury through the review of existing evidence.