Gibson Angela L F, Holmes James H, Shupp Jeffrey W, Smith David, Joe Victor, Carson Joshua, Litt Jeffrey, Kahn Steven, Short Tracee, Cancio Leopoldo, Rizzo Julie, Carter Jeffrey E, Foster Kevin, Lokuta Mary A, Comer Allen R, Smiell Janice M, Allen-Hoffmann B Lynn
Department of Surgery, University of Wisconsin School of Medicine and Public Health, 600 Highland Avenue, Madison, WI 53792, United States.
Department of Surgery, Wake Forest University School of Medicine, Medical Center Boulevard, Winston-Salem, NC 27157, United States.
Burns. 2021 Aug;47(5):1024-1037. doi: 10.1016/j.burns.2021.04.021. Epub 2021 Apr 23.
This phase 3 study evaluated StrataGraft construct as a donor-site sparing alternative to autograft in patients with deep partial-thickness (DPT) burns.
Patients aged ≥18 years with 3-49% total body surface area (TBSA) thermal burns were enrolled. In each patient, 2 DPT areas (≤2000cm total) of comparable depth after excision were randomized to either cryopreserved StrataGraft or autograft. Coprimary endpoints were: the difference in percent area of StrataGraft treatment site and autograft treatment site autografted at Month 3 (M3), and the proportion of patients achieving durable wound closure of the StrataGraft site without autograft at M3. Safety assessments were performed in all patients. Efficacy and safety follow-up continued to 1 year.
Seventy-one patients were enrolled. By M3, there was a 96% reduction in mean percent area of StrataGraft treatment sites that required autografting, compared with autograft treatment sites (4.3% vs 102.1%, respectively; P<.0001). StrataGraft treatment resulted in durable wound closure at M3 without autografting in 92% (95% CI: 85.6, 98.8; n/n 59/64) of patients for whom data were available. The most common StrataGraft-related adverse event was pruritus (15%).
Both coprimary endpoints were achieved. StrataGraft may offer a new treatment for DPT burns to reduce the need for autografting.
NCT03005106.
本3期研究评估了StrataGraft构建物作为深部部分厚度（DPT）烧伤患者自体移植供区保留替代物的效果。
纳入年龄≥18岁、总体表面积（TBSA）为3%-49%的热烧伤患者。在每位患者中，将切除后深度相当的2个DPT区域（总面积≤2000cm）随机分配至冷冻保存的StrataGraft或自体移植组。共同主要终点为：第3个月（M3）时StrataGraft治疗部位和自体移植治疗部位自体移植面积百分比的差异，以及M3时StrataGraft部位在未进行自体移植情况下实现持久伤口闭合的患者比例。对所有患者进行安全性评估。疗效和安全性随访持续至1年。
共纳入71例患者。到M3时，与自体移植治疗部位相比，StrataGraft治疗部位需要自体移植的平均面积百分比降低了96%（分别为4.3%和102.1%；P<0.0001）。对于有可用数据的患者，StrataGraft治疗在M3时未进行自体移植的情况下实现了92%（95%CI：85.6，98.8；n/n 59/64）的持久伤口闭合。最常见的与StrataGraft相关的不良事件是瘙痒（15%）。
两个共同主要终点均达成。StrataGraft可能为DPT烧伤提供一种新的治疗方法，以减少自体移植的需求。
NCT03005106。
