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.

Study Overview

• Status: Completed
• Conditions: Second-degree Burn
• Intervention / Treatment: Drug: Pirfenidone Oral Product

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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.	Drug: Pirfenidone Oral Product; A pill containing 600 mg of pirfenidone; Other Names: Kitoscell
NO_INTERVENTION: Usual Care; 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?

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

Collaborators and Investigators

• Sponsor: Universidad Autonoma de Nuevo Leon
• Investigators: Principal Investigator: Gabriel A Mecott-Rivera, MMS, Universidad Autonoma de Nuevo Leon

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2017
• Primary Completion (ACTUAL): June 22, 2017
• Study Completion (ACTUAL): June 22, 2017

Study Registration Dates

• First Submitted: May 7, 2018
• First Submitted That Met QC Criteria: May 17, 2018
• First Posted (ACTUAL): May 21, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 21, 2018
• Last Update Submitted That Met QC Criteria: May 17, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Pirfenidone; Wound Healing; Burns; Partial-thickness burn wounds; Re-epithelization; Second-Degree Wound
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Pirfenidone
• Other Study ID Numbers: CP14-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

All information will be delivered by request.

Possible individual participant data includes:

Database Original Protocol Informed Consent

• IPD Sharing Time Frame: Data will be available from May 2018 to May 2020
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No