School of Nursing, Faculty of Health Sciences, Queen's University, Kingston, ON, Canada.
Int Wound J. 2017 Dec;14(6):1029-1035. doi: 10.1111/iwj.12753. Epub 2017 May 16.
The objective of this prospective, non-randomised study was to evaluate the performance of an antibacterial foam dressing containing methylene blue and gentian violet (Hydrofera Blue Classic dressing ) for the management of chronic wounds with local infection. Patients in this study were ≥18 years of age (n = 29), and each had at least one chronic wound ≥1 cm in size that showed signs of localised infection or critical colonisation but with good potential for healing based on clinical assessment. To all of these wounds, the dressing was applied and changed three times per week over the 4-week study period. The primary endpoints of the study were: (i) changes in wound surface area measurement, (ii) changes in Pressure Ulcer Scale for Healing (PUSH) scores, (iii) changes in percent surface area of devitalised tissue (i.e., yellow slough or other necrotic tissue) and (iv) changes in clinical signs associated with localised wound infection/critical colonisation. Participants were evaluated at presentation (week 0 = baseline), week 2 and at week 4 (end of the study). The 29 patients completed the study, and at week 4, the following wound improvements were observed: (i) baseline mean wound surface area was significantly reduced by 42·5%, from 21·4 to 12·3 cm at week 4 (P = 0·005); (ii) baseline mean PUSH score decreased significantly from 13·3 to 10·7 at week 4 (P < 0·001); (iii) baseline mean wound coverage by devitalised tissue (%) was significantly reduced, from 52·6 % to 11·4% at week 4 (P < 0·001) and (iv) the mean UPPER and LOWER wound infection scores were reduced from 3·6 at baseline to 0·9 at week 4 (75%; P < 0.001). These results indicate that the Hydrofera Blue Classic dressing was effective at managing these chronic wounds and helped them progress onto a healing trajectory.
本前瞻性、非随机研究旨在评估一种含有亚甲蓝和龙胆紫的抗菌泡沫敷料（Hydrofera Blue Classic 敷料）在治疗局部感染的慢性伤口中的疗效。该研究纳入的患者年龄均≥18 岁（n=29），且每位患者至少有一个慢性伤口，其大小≥1cm，且表现出局部感染或临界定植的迹象，但根据临床评估具有良好的愈合潜力。在整个 4 周的研究期间，所有这些伤口均应用该敷料，每周更换 3 次。该研究的主要终点包括：（i）伤口表面积测量的变化，（ii）伤口愈合压力溃疡评分（PUSH）的变化，（iii）失活组织面积百分比（即黄色腐肉或其他坏死组织）的变化，以及（iv）与局部伤口感染/临界定植相关的临床体征的变化。在就诊时（第 0 周=基线）、第 2 周和第 4 周（研究结束时）对参与者进行评估。29 名患者完成了该研究，在第 4 周时观察到以下伤口改善：（i）基线时的平均伤口表面积显著减少了 42.5%，从第 0 周的 21.4cm2减少到第 4 周的 12.3cm2（P=0.005）；（ii）基线时的平均 PUSH 评分从 13.3 显著降低至 10.7（P＜0.001）；（iii）基线时失活组织（%）覆盖的平均伤口面积显著减少，从第 0 周的 52.6%减少至第 4 周的 11.4%（P＜0.001），以及（iv）平均 UPPER 和 LOWER 伤口感染评分从基线时的 3.6 降低至第 4 周时的 0.9（75%；P＜0.001）。这些结果表明，Hydrofera Blue Classic 敷料在治疗这些慢性伤口方面是有效的，有助于它们进入愈合轨道。
