Pirfenidone and Its Efficacy in Wound Re-Epithelization in Patients With Second-Degree Burns: A Proof-of-Concept Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 主要终点
- Epidermal re-epithelization
研究概览
简要总结
Burn patients which skin has been lost a rapid growth of the skin is a foremost in their treatment. Due to the injury, burn patients undergo a systemic inflammation that helps the skin heal faster. However, several studies have shown that this inflammation increases the levels of several inflammatory molecules that impairs skin growing, which further delays the recovery of burn patients. As such, by inhibiting these inflammatory molecules with the administration of a medication called pirfenidone burn patients might present faster rates of skin growth and recovery. Thus, patients suffering from a burn injury will be recruited at the emergency department of the Hospital University in Monterrey Mexico. Afterward, patients will be randomized to either receive pirfenidone 600 mg orally once per day or usual care consisting of covering the wound with hydrocolloid dressings. To assess the amount of newly growth skin investigators will take a small piece of the skin to further evaluate it through a microscope.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
The principal investigator, the person in charge of gathering the data, and the person analyzing the data will be blinded
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with second-degree burns from any etiology with less than 24 hours of evolution.
排除标准
- •Patients <18 years old
- •Patients allergic to pirfenidone
- •Pregnant patients
- •Patients with renal or hepatic failure
- •Patients who are not able to take the medication orally
- •Conditions or drugs that alter wound healing (i.e. any kind of diabetes, lupus, having a history of using steroids, rheumatoid arthritis)
研究组 & 干预措施
Pirfenidone 600 mg
Burn patients randomly allocated to this group will receive pirfenidone 600 mg orally once per day for 21 days additionally to the coverage of the wound with non-adherent gauzes and bandages. The aforementioned coverings will be changed every 3 or 4 days until a complete re-epithelization is achieved.
干预措施: Pirfenidone Oral Product (Drug)
结局指标
主要结局
Epidermal re-epithelization
时间窗: Day 7
Thickness of the epidermal re-epithelization measured in micrometers using a digitial image software
次要结局
- Presence of Fibrosis(Day 0 and 7)
- Basal Membrane Integrity(Day 0 and 7)
- Presence of Collagen Fibers(Day 0 and 7)
- Clinical Evaluations of Wound's Re-Epithelization(Day 7)
研究者
Gabriel Angel Mecott-Rivera
Principal Investigator
Universidad Autonoma de Nuevo Leon
