Pirfenidone and Its Role in Burn Wound Healing

NCT03530150 | Completed Phase 2 DMC

• 1 other identifier: CP14-004
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Second-degree Burn

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Epidermal re-epithelization

  Thickness of the epidermal re-epithelization measured in micrometers using a digitial image software

  Day 7

Secondary Outcomes (4)

• Presence of Fibrosis

  Day 0 and 7

• Basal Membrane Integrity

  Day 0 and 7

• Presence of Collagen Fibers

  Day 0 and 7

• Clinical Evaluations of Wound's Re-Epithelization

  Day 7

Study Arms (2)

Pirfenidone 600 mg

ACTIVE COMPARATOR

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

Usual Care

NO INTERVENTION

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.

Interventions

Pirfenidone Oral Product DRUG

A pill containing 600 mg of pirfenidone

Also known as: Kitoscell

Pirfenidone 600 mg

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with second-degree burns from any etiology with less than 24 hours of evolution.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Universidad Autonoma de Nuevo Leon: lead

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Gabriel A Mecott-Rivera, MMS

  Universidad Autonoma de Nuevo Leon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The principal investigator, the person in charge of gathering the data, and the person analyzing the data will be blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Burn patients will be divided to receive either 600 mg of pirfenidone or usual care

Study Record Dates

• First Submitted: May 7, 2018
• First Posted: May 21, 2018
• Study Start: January 1, 2017
• Primary Completion: June 22, 2017
• Study Completion: June 22, 2017
• Last Updated: May 21, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be available from May 2018 to May 2020