University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Hamburg Institute for Hygiene and Environment, Hamburg, Germany.
J Wound Care. 2023 Jul 2;32(7):422-427. doi: 10.12968/jowc.2023.32.7.422.
By default, the antimicrobial efficacy of antiseptics used in wound management is tested in vitro under standardised conditions according to European standard DIN EN 13727, with albumin and sheep erythrocytes used as organic challenge. However, it is not clear whether these testing conditions adequately reflect the wound bed environment and its interaction with antiseptic products intended to be used in wounds in humans.
This study compared the efficacy of different commercial antiseptic products based on octenidine dihydrochloride (OCT), polyhexamethylene biguanide (PHMB) and povidone-iodine under challenge with human wound exudate collected from the hard-to-heal wounds of patients, compared to the standardised organic load, in an in vitro setting according to DIN EN 13727.
The bactericidal efficacy of the tested products was reduced to a different extent when challenged with human wound exudate, compared to the standardised conditions. Overall, OCT-based products showed the necessary germ count reductions at the shortest exposure times (e.g., 15 seconds for Octenisept (Schülke & Mayr GmbH, Germany)). PHMB-based products were the least efficient. In addition to the protein content, other components of wound exudate, such as the microbiota, seem to influence the efficacy of antiseptics.
This study demonstrated that the standardised in vitro test conditions may only partially reflect actual wound bed conditions in humans.
根据欧洲标准 DIN EN 13727,默认情况下,用于伤口管理的防腐剂的抗菌功效是在标准化条件下通过体外测试进行检测的,使用白蛋白和绵羊红细胞作为有机挑战物。然而,目前尚不清楚这些测试条件是否充分反映了伤口床环境及其与拟用于人体伤口的防腐剂产品的相互作用。
本研究根据 DIN EN 13727 标准,比较了不同市售基于奥替尼啶二盐酸盐(OCT)、聚六亚甲基双胍(PHMB)和聚维酮碘的防腐剂产品在受到来自患者难愈性伤口的人源伤口渗出液挑战时的功效,与标准化的有机负荷进行了比较。
与标准化条件相比,测试产品在受到人源伤口渗出液挑战时,杀菌功效不同程度地降低。总体而言,基于 OCT 的产品在最短暴露时间(例如,Octenisept(德国舒尔克和梅尔有限公司)为 15 秒)下显示出必要的细菌计数减少。基于 PHMB 的产品效率最低。除了蛋白质含量外,伤口渗出液的其他成分,例如微生物群,似乎也会影响防腐剂的功效。
本研究表明,标准化的体外测试条件可能仅部分反映实际的人体伤口床条件。