Pirfenidone and Its Role in Burn Wound Healing

NCT ID: NCT03530150

Last Updated: 2018-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2017-06-22

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Pirfenidone Oral Product

Intervention Type: DRUG

A pill containing 600 mg of pirfenidone

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Pirfenidone Oral Product

A pill containing 600 mg of pirfenidone

Intervention Type: DRUG

Other Intervention Names

Kitoscell

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Autonoma de Nuevo Leon

OTHER

Sponsor Role: lead

Responsible Party

Gabriel Angel Mecott-Rivera

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gabriel A Mecott-Rivera, MMS

Role: PRINCIPAL_INVESTIGATOR

Universidad Autonoma de Nuevo Leon

Other Identifiers

CP14-004

Identifier Type: -

Identifier Source: org_study_id