Pirfenidone and Its Role in Burn Wound Healing

Second-degree Burn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03530150
• Other study ID #: CP14-004
• Status: Completed
• Phase: Phase 2
• Start date: January 1, 2017
• Est. completion date: June 22, 2017

Study information

• Verified date: May 2018
• Source: Universidad Autonoma de Nuevo Leon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: June 22, 2017
• Est. primary completion date: June 22, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Burns
• Second-degree Burn

Intervention

Drug:
• Pirfenidone Oral Product
A pill containing 600 mg of pirfenidone

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Autonoma de Nuevo Leon

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Epidermal re-epithelization	Thickness of the epidermal re-epithelization measured in micrometers using a digitial image software	Day 7
Secondary	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
Secondary	Basal Membrane Integrity	A qualitative assessment of the presence and integrity of the basal membrane using a light field microscope.	Day 0 and 7
Secondary	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
Secondary	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