Platelets in Acute Wounds: A Punch Biopsy Study (PAWS II)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Medtronic
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Time to 100% wound closure, measured at Days 7, 14, 21, 28, 35
研究概览
简要总结
This study will examine whether platelet gel positively affects wound healing. Platelet gel will be used to treat punch biopsy wounds and the results will be compared to results from wounds treated with a control treatment.
详细描述
Platelets contribute to the healing process in soft tissue by providing the initial hemostasis that occurs following injury, a framework for fibrin matrix formation and contribution of growth factors.
According to the US National Institutes of Health, surgical procedures are considered a form of controlled injury, so many of the complications faced by surgery patients are very similar to those faced by trauma patients. Scientists are currently investigating ways to treat wounds caused by trauma, burns or surgical inventions with biological agents (i.e. growth factors) or new drugs. Growth factor priming of acute wound sites pre-activates the cellular and molecular components of tissue repair, prior to tissue injury.
Objectives are aimed at gathering information to establish evidence that autologous platelet gel positively effects the healing of acute wounds.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Normal volunteers
- •18 years old or older
排除标准
- •Pregnant or lactating
- •Diabetic, keloid former, collagen vascular disease
- •Body mass index >30kg/m2
- •Known history of HIV/AIDS; Hepatitis A, B, or C
- •Bleeding disorder
- •Aspirin, non-steroidal anti-inflammatory drug (NSAID) or anticoagulant user
- •Cancer, or treatment for cancer, in past 5 years
结局指标
主要结局
Time to 100% wound closure, measured at Days 7, 14, 21, 28, 35
次要结局
- Measurements of wound depth at each visit
- Measurement of residual scarring at 6 months post wounding