RCT protocol development to evaluate MPPT in venous leg ulcers

“伤口和溃疡难以愈合或无法愈合的主要原因是感染。在过去的十年里，使用抗菌剂治疗伤口感染一直是标准的医疗实践，但几项临床研究表明，它们的影响很小，而且很好，FDA不再鼓励使用它们。此外，抗生素和防腐剂都是造成抗菌素耐药性的重要因素，这是一个全球性的健康问题。微孔微粒技术(MPPT)是一种新的方法，可以作为伤口感染和愈合的被动免疫疗法。MPPT破坏武器细菌和真菌对免疫系统的使用，结果是免疫系统重新控制伤口和伤口愈合过程。在一项比较临床研究中，MPPT消除伤口感染和开始愈合的速度比抗生素和防腐剂快60%，住院天数减少31%。仅在英国，每年就有2.2个磨坊伤口需要治疗，这给NHS造成了53亿GB的直接成本。据估计，MPPT可以将伤口护理成本降低21%，并可以帮助许多受创伤影响较大的患者。MPPT获得了专利，有望满足全球未得到满足的临床需求。MPPT不是抗菌剂，也不会导致耐药性的产生。支持引入新的医疗保健技术的一个关键因素是获得NICE的评估，NICE评估所有数据并就该方法的健康益处提供意见。该项目的目的是为接受这种评估做好第一阶段的准备。一旦实现，这将被用来支持在英国引入这项技术，并支持出口努力，因为世界上大多数国家都在密切研究良好的建议。“

"The main reason wounds and ulcers have difficulty or fail to heal is infection. For the past decade, it has been standard medical practice to use antimicrobials to treat wound infections, but several clinical studies have shown that they have minimal effects and NICE and the FDA no longer encourage their use. Furthermore, both antibiotics and antiseptics strongly contribute to the creation of antimicrobial resistance, a global health problem.Micropore particle technology (MPPT) is a novel approach which acts as a passive immunotherapy for wound infection and healing. MPPT disrupts the weaponry bacteria and fungi use against the immune system with the result that the immune system regains control of the wound and the wound healing process. In a comparative clinical study MPPT removed wound infections and initiated healing 60% quicker than an antibiotic and an antiseptic and it reduced the number of hospitalisation days by 31%. Annually in the UK alone, 2.2 mill wounds require treatment causing direct costs to the NHS of £5.3 bn. Estimates indicate that MPPT can reduce the costs of wound care by 21% and can assist many patients who are strongly affected by wounds. MPPT is patented and expected to meet a global unmet clinical need. MPPT is not antimicrobial and will not contribute to the creation of resistance.A key factor in supporting the introduction of a new healthcare technology is to obtain an appraisal from NICE, which evaluates all data and offers an opinion on the health benefits of the approach. The purpose of this project is to prepare the first phase towards receiving such an appraisal. Once achieved, this will be used to support the introduction of the technology in the UK as well as to support export efforts as NICE recommendations are closely stuied in most countries worldwide."