Skip to main content
OpenTrials
Completed

NCT Number: NCT03530150

Pirfenidone and Its Role in Burn Wound Healing

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with second-degree burns from any etiology with less than 24 hours of evolution.

Exclusion criteria

  • 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)

Treatment and study plan

Pirfenidone Oral Product

Drug

A pill containing 600 mg of pirfenidone

Other names: Kitoscell

Primary outcomes

  1. Epidermal re-epithelization

    Time frame: Day 7

    Thickness of the epidermal re-epithelization measured in micrometers using a digitial image software

Secondary outcomes

  1. Presence of Fibrosis

    Time frame: Day 0 and 7

    A qualitative assessment of the presence of fibrotic tissue in the extracellular matrix using a light field microscope.

  2. Basal Membrane Integrity

    Time frame: Day 0 and 7

    A qualitative assessment of the presence and integrity of the basal membrane using a light field microscope.

  3. Presence of Collagen Fibers

    Time frame: Day 0 and 7

    A qualitative assessment of the presence of collagen fibers in the dermis using a light field microscope.

  4. Clinical Evaluations of Wound's Re-Epithelization

    Time frame: Day 7

    Clinical evaluation of wound's re-epithelization based on the judgement of an experienced plastic surgeon

Sponsors and collaborators

Lead sponsor

Universidad Autonoma de Nuevo Leon

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 21, 2018
Registry last updated
May 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.