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。在过去的十年中，使用抗菌药物治疗伤口感染一直是标准的医疗实践，但一些临床研究表明，它们的作用很小，NICE和FDA不再鼓励使用它们。此外，抗生素和防腐剂都强烈有助于产生抗菌素耐药性，这是一个全球性的健康问题。微孔颗粒技术（MPPT）是一种新的方法，作为被动免疫治疗伤口感染和愈合。MPPT破坏细菌和真菌对抗免疫系统的武器，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消除了伤口感染，比抗生素和防腐剂快60%，并将住院天数减少了31%。仅在英国，每年就有220万伤口需要治疗，导致NHS的直接成本达到53亿英镑。据估计，MPPT可以将伤口护理成本降低21%，并可以帮助许多受伤口严重影响的患者。MPPT已获得专利，有望满足全球未满足的临床需求。MPPT不具有抗菌性，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，该评估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，这将用于支持在英国引进该技术以及支持出口工作，因为NICE的建议在全球大多数国家都得到了密切的研究。"

"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."