Pirfenidone and Its Role in Burn Wound Healing

Study Overview
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Brief Summary
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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.

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

Conditions
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Second-degree Burn

Intervention / Treatment
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* Drug: Pirfenidone Oral Product


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Burn patients will be divided to receive either 600 mg of pirfenidone or usual care
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pirfenidone 600 mg<br>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. | Drug: Pirfenidone Oral Product<br>* A pill containing 600 mg of pirfenidone<br>* Other names: Kitoscell;|
| No Intervention: Usual Care<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epidermal re-epithelization | Thickness of the epidermal re-epithelization measured in micrometers using a digitial image software | Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of Fibrosis | A qualitative assessment of the presence of fibrotic tissue in the extracellular matrix using a light field microscope. | Day 0 and 7 | 
| Basal Membrane Integrity | A qualitative assessment of the presence and integrity of the basal membrane using a light field microscope. | Day 0 and 7 | 
| Presence of Collagen Fibers | A qualitative assessment of the presence of collagen fibers in the dermis using a light field microscope. | Day 0 and 7 | 
| Clinical Evaluations of Wound's Re-Epithelization | Clinical evaluation of wound's re-epithelization based on the judgement of an experienced plastic surgeon | Day 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pirfenidone, Burns, Partial-thickness burn wounds, Re-epithelization, Second-Degree Wound, Wound Healing