Pirfenidone and Its Role in Burn Wound Healing

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

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.

Burns, Partial-thickness burn wounds, Re-epithelization, Second-Degree Wound, Pirfenidone, Wound Healing

The principal investigator, the person in charge of gathering the data, and the person analyzing the data will be blinded

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.

Burn patients randomly allocated to this group will only be treated by the usual care of our hospital which consists in covering the wound with non-adherent gauzes and bandages. These covering will be changed every 3 or 4 days until a complete re-epithelization is achieved.

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

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

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

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

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)

All information will be delivered by request. Possible individual participant data includes: Database Original Protocol Informed Consent