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临床试验/NCT03530150
NCT03530150已完成2 期

Pirfenidone and Its Efficacy in Wound Re-Epithelization in Patients With Second-Degree Burns: A Proof-of-Concept Randomized Controlled Trial

Universidad Autonoma de Nuevo Leon0 个研究点目标入组 8 人开始时间: 2017年1月1日最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

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

发起方
Universidad Autonoma de Nuevo Leon
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gabriel Angel Mecott-Rivera

Principal Investigator

Universidad Autonoma de Nuevo Leon

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