West Boca Center for Wound Healing, Coconut Creek, FL.
Surgical Services, Berger Health System, Circleville, OH.
Wounds. 2022 Apr;34(4):E34-E36. doi: 10.25270/wnds/2022.e34e36.
This is the second of 3 planned articles reporting on a prospective, multicenter, randomized controlled trial assessing the efficacy of fish skin graft in the management of diabetic foot ulcers in comparison with the standard of care (collagen alginate dressing).
The primary end point of this prospective randomized trial is the number of closed wounds at 12 weeks.
As of the time of this writing, 94 patients had completed the protocol. At 12-week follow-up, healing was achieved in 63.0% of index ulcers (29 of 46 patients) in the acellular fish skin graft group compared with 31.3% in the control group (15 of 48 patients) (P =.0036). In both groups, the mean time to healing was 7 weeks. The median number of applications of the fish skin graft to achieve healing was 6.
A clinically and statistically significant difference in healing was observed between patients treated with acellular fish skin graft and those treated with a collagen alginate dressing. The data support the completion of this prospective randomized trial.
这是 3 篇计划中的第 2 篇文章，报告了一项前瞻性、多中心、随机对照临床试验的结果，该试验评估了鱼皮移植物在治疗糖尿病足溃疡方面的疗效，与标准治疗（胶原-藻酸盐敷料）相比。
本前瞻性随机试验的主要终点是 12 周时闭合的伤口数量。
截至本报告撰写之时，94 例患者已完成方案。在 12 周随访时，脱细胞鱼皮移植物组的指数溃疡（46 例患者中的 29 例）愈合率为 63.0%，而对照组（48 例患者中的 15 例）为 31.3%（P =.0036）。在两组中，平均愈合时间均为 7 周。实现愈合所需的鱼皮移植物中位数使用次数为 6 次。
与接受胶原-藻酸盐敷料治疗的患者相比，接受脱细胞鱼皮移植物治疗的患者在愈合方面存在显著的临床和统计学差异。数据支持完成这项前瞻性随机试验。
