Second-degree Burn
Conditions
Keywords
Burns, Partial-thickness burn wounds, Re-epithelization, Second-Degree Wound, Pirfenidone, Wound Healing
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.
Interventions
A pill containing 600 mg of pirfenidone
Sponsors
Universidad Autonoma de Nuevo Leon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
The principal investigator, the person in charge of gathering the data, and the person analyzing the data will be blinded
Intervention model description
Burn patients will be divided to receive either 600 mg of pirfenidone or usual care
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Epidermal re-epithelization | Day 7 | Thickness of the epidermal re-epithelization measured in micrometers using a digitial image software |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
Outcome results
None listed