NCT05766982撤回不适用
Fish Skin Grafts With Platelet-rich Plasma Compared to Fish Skin Grafts for Chronic Wound Healing: Randomized, Prospective Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Time to wound being deemed healed or 6 months
研究概览
简要总结
This prospective, randomized pilot study compares the use of a xenograft with PRP to a xenograft alone for chronic, nonhealing wounds.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is over the age of 18 years;
- •The targeted wound is deemed a chronic, nonhealing wound after six weeks of treatment; - - Patient of Dr. Eldridge, Dr. Glenn, or Dr. Worley;
- •Target wound size must be between 2 cm x 2 cm x 0.1 cm deep and 10 cm x 10 cm x 5 cm deep;
- •Surgical candidate for standard of care Kerecis® xenograft surgery.
排除标准
- •Patient with hemoglobin values less than 6.9 g/dL drawn at least 30 days prior to the Kerecis® xenograft surgery;
- •Patient with a known allergy or other sensitivity to fish material;
- •Patient is currently undergoing chemotherapy or radiation therapy;
- •The targeted wound is of autoimmune origin; and Non-English-speaking patients.
结局指标
主要结局
Time to wound being deemed healed or 6 months
时间窗: 6 months
Assessed by time, surface area of wound, wound volume and relative surface size
次要结局
- Wound quality of life(6 months)
研究者
研究点 (2)
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