Mueller S, Vogt P M, Steinau H-U, Leuner C, Hopp M, Bosse B, Fleischer W, Reimer K
Mundipharma Research GmbH & Co. KG, Limburg/Lahn, Germany.
Dermatology. 2006;212 Suppl 1:77-81. doi: 10.1159/000089203.
Various standardized and/or validated models exist to test wound healing products. This article discusses their usefulness in clinical practice.
Major barriers to wound healing have been identified after intense interaction of research and practitioners. Although extensively tested, wound healing products are still associated with trial and error due to the high variability and complexity associated with the treatment of wounds. Therefore, the results of preclinical testing are compared and contrasted with clinical observations of a liposomal hydrogel containing 3% povidone-iodine (Repithel, PVP-ILH) to assess their expressiveness and to give the practitioner more guidance in application.
Testing of PVP-ILH included physicochemical testing according to ISO norms, testing in in vitro and in vivo models. The obtained results are compared to the clinical profile of the obtained product in randomized controlled trials and ultimately expressive case studies.
PVP-ILH displays good local tolerance, the basis for use in sensitive and predamaged tissue. As observed in laboratory testing, it readily provides moisture and takes up limited amounts of moisture. This was also seen in the clinical testing, as the ability to keep wounds moist and incorporate a certain -- but not large -- amount of exudates. Clinical results also show clean, well-debrided wounds, an effect that (in the absence of an established model for wound cleansing) was traced to the hydrogel component carbomer.
Recent consensus advocates the concept of wound bed preparation as a systematic approach to removing barriers to healing (TIME). Based on the results, tissue (removing non-viable tissue and debris) and moisture (balance) can now be better understood, and infection/inflammation (control) and edge (progressing, non-advancing or undermining wound edges) are reviewed together with previously published data to assess all aspects potentially impeding wound healing.
PVP-ILH successfully removes barriers to wound healing, thus laying the foundation to high-quality wound closure. Results from many scientific disciplines can help the user to better understand a product, standardization of testing is the only way of making results comparable.
存在多种标准化和/或经过验证的模型来测试伤口愈合产品。本文讨论了它们在临床实践中的实用性。
经过研究人员与从业者的深入交流,已确定了伤口愈合的主要障碍。尽管伤口愈合产品经过了广泛测试,但由于伤口治疗存在高度变异性和复杂性,其使用仍存在尝试和错误的情况。因此,将含3%聚维酮碘的脂质体水凝胶(Repithel,PVP - ILH)的临床前测试结果与临床观察结果进行比较和对比,以评估其有效性,并为从业者在应用中提供更多指导。
PVP - ILH的测试包括根据ISO标准进行的理化测试、体外和体内模型测试。将获得的结果与该产品在随机对照试验以及最终的典型病例研究中的临床情况进行比较。
PVP - ILH显示出良好的局部耐受性,这是其用于敏感和预先受损组织的基础。正如在实验室测试中观察到的,它能轻易提供水分且吸收的水分量有限。这在临床测试中也有体现,即保持伤口湿润并容纳一定量(但不多)渗出液的能力。临床结果还显示伤口清洁、清创良好,这种效果(在缺乏既定的伤口清创模型的情况下)可追溯到水凝胶成分卡波姆。
最近的共识提倡将伤口床准备作为一种消除愈合障碍的系统方法(TIME)。基于这些结果,现在可以更好地理解组织(清除无活力组织和碎片)和水分(平衡),并结合先前发表的数据对感染/炎症(控制)和边缘(伤口边缘进展、无进展或破坏)进行评估,以评估所有可能阻碍伤口愈合的方面。
PVP - ILH成功消除了伤口愈合的障碍,从而为高质量伤口闭合奠定了基础。许多科学学科的结果可以帮助使用者更好地理解一种产品,测试标准化是使结果具有可比性的唯一方法。