Caravaggi Carlo, Grigoletto Francesco, Scuderi Nicolò
1Diabetic Foot Department, Istituto Clinico Città Studi, Milano, Italy; Email:
Department of Environmental Medicine and Public Health, University of Padua, Italy.
Wounds. 2011 Aug;23(8):228-35.
The FAST study evaluated the performance and safety of Hyalomatrix® PA (a dermal substitute) in the treatment of chronic wounds of different etiology. This was a multicenter, prospective, observational study involving 70 Italian centers and 262 elderly patients. Patients were observed from the start of treatment with a dermal substitute (Hyalomatrix® PA [HPA]) until healthy dermal tissue suitable for a thin autograft was visible or until the growth of new epithelium from the wound edge was reported. Tracking the wound edge advancement was used to assess the dermal substitute's performance. The main endpoint was the reduction in threshold area (≥ 10%) of the ulcer. Treated ulcers were characterized as follows: 46% vascular, 25% diabetic foot, 12% traumatic wounds, 2% pressure ulcers and 15% other. Re-epithelization (≥ 10%) was achieved in 83% of ulcers in a median time of 16 days. Twenty-six percent (26%) of wounds achieved 75% re-epithelization within the 60-day follow-up period using only HPA treatment. A follow-up showed that 84% of ulcers achieved complete re-epithelialization by secondary intention. These findings indicate that HPA is a safe and effective dermal substitute. The results show that the re-epithelization process following HPA treatment is independent upon etiology, area, and depth of the ulcer, and treatment is more effective on acute ulcer formation.
FAST研究评估了Hyalomatrix® PA（一种真皮替代物）治疗不同病因慢性伤口的性能和安全性。这是一项多中心、前瞻性、观察性研究，涉及70个意大利中心和262名老年患者。从开始使用真皮替代物（Hyalomatrix® PA [HPA]）治疗起观察患者，直至可见适合薄自体移植的健康真皮组织，或直至报告伤口边缘有新上皮生长。通过追踪伤口边缘进展来评估真皮替代物的性能。主要终点是溃疡阈值面积减少（≥10%）。治疗的溃疡特征如下：46%为血管性，25%为糖尿病足，12%为创伤性伤口，2%为压疮，15%为其他。83%的溃疡在中位时间16天内实现了再上皮化（≥10%）。仅使用HPA治疗，26%的伤口在60天随访期内实现了75%的再上皮化。随访显示，84%的溃疡通过二期愈合实现了完全再上皮化。这些发现表明HPA是一种安全有效的真皮替代物。结果表明，HPA治疗后的再上皮化过程与溃疡的病因、面积和深度无关，且对急性溃疡形成的治疗更有效。
