Mrugala Andrew, Sui Audrey, Plummer Malgorzata, Altman Igor, Papineau Elaine, Frandsen Devn, Hill Danielle, Ennis William J
Saint Louis University School of Medicine, St. Louis, MO, USA.
Chicago College Osteopathic Medicine, Midwestern University, Downers Grove, IL, USA.
Int Wound J. 2016 Aug;13(4):485-92. doi: 10.1111/iwj.12458. Epub 2015 May 14.
A case series of five patients with a total of six chronic non-healing wounds (>30 day duration) were non-randomly selected to evaluate the performance, safety and handling properties of dehydrated human amnion/chorion membrane allograft, an amniotic membrane scaffolding product. The patients had lower extremity wounds that had previously failed standard of care within a university outpatient/inpatient wound healing programme. Five wounds treated with dehydrated amnion/chorion membrane allograft showed a mean 43% area reduction from baseline (51% median) at 3 weeks into treatment and completely healed with a 64-day median time to closure (SD ±27·6 days). One wound worsened at 3 weeks and was found to have a complete central vein obstruction that was treated with long-term mild compression but still eventually healed at 6 months. Removing this outlier, the four responding wounds had a 72% mean and 69% median change in area from baseline, at the 3 week point. All five patients received only one application of dehydrated human amnion/chorion membrane allograft, and there were no adverse events. The product was easy to use, administer and handle. In summary, dehydrated human amnion/chorion membrane allograft appears to be a safe, effective and easy to use therapy for chronic non-healing wounds. This study describes the details of these clinical cases and provides an overview of the current evidence on the use of amniotic tissue in clinical practice.
非随机选取了5例患者共6处慢性难愈合伤口(持续时间>30天),以评估脱细胞人羊膜/绒毛膜同种异体移植片(一种羊膜支架产品)的性能、安全性和操作特性。这些患者的下肢伤口在大学门诊/住院伤口愈合项目中先前未达到标准护理效果。5处用脱细胞羊膜/绒毛膜同种异体移植片治疗的伤口在治疗3周时平均面积较基线减少43%(中位数为51%),并完全愈合,中位愈合时间为64天(标准差±27.6天)。有一处伤口在3周时恶化,发现有完全性中央静脉阻塞,采用长期轻度压迫治疗,但最终仍在6个月时愈合。去除这一异常值后,4处有反应的伤口在3周时面积较基线平均变化72%,中位数变化69%。所有5例患者仅接受了一次脱细胞人羊膜/绒毛膜同种异体移植片治疗,且无不良事件发生。该产品易于使用、给药和操作。总之,脱细胞人羊膜/绒毛膜同种异体移植片似乎是一种安全、有效且易于使用的慢性难愈合伤口治疗方法。本研究描述了这些临床病例的细节,并概述了目前临床实践中使用羊膜组织的证据。