Pirfenidone and Its Role in Burn Wound Healing

Universidad Autonoma de Nuevo Leon

Status and phase: Completed; Phase 2

Conditions: Second-degree Burn

Treatments: Drug: Pirfenidone Oral Product

Study type: Interventional

Funder types: Other

Identifiers

NCT03530150

CP14-004

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

8 participants in 2 patient groups

Pirfenidone 600 mg

Active Comparator group

Description:

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.

Treatment:

Drug: Pirfenidone Oral Product

Usual Care

No Intervention group

Description:

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.