Pirfenidone and Its Role in Burn Wound Healing

Phase 2

Completed

• Conditions: Second-degree Burn
• Interventions: Drug: Pirfenidone Oral Product

• Registration Number: NCT03530150
• Lead Sponsor: Universidad Autonoma de Nuevo Leon

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-01
• Primary Completion: 2017-06-22
• Study Completion: 2017-06-22
• Status Verified: 2018-05
• Study First Submitted: 2018-05-07
• Study First Submitted QC: 2018-05-17
• Last Update Submitted: 2018-05-17
• Study First Posted: 2018-05-21
• Last Update Posted: 2018-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pirfenidone 600 mg	Pirfenidone Oral Product	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.

Primary Outcome Measures

Name	Time	Method
Epidermal re-epithelization	Day 7	Thickness of the epidermal re-epithelization measured in micrometers using a digitial image software

Secondary Outcome Measures

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