Pirfenidone Oral Product
DrugA pill containing 600 mg of pirfenidone
Other names: Kitoscell
NCT Number: NCT03530150
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.
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Notify Me18 year–60 year
All sexes
Interventional
Phase 2
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A pill containing 600 mg of pirfenidone
Other names: Kitoscell
Time frame: Day 7
Thickness of the epidermal re-epithelization measured in micrometers using a digitial image software
Time frame: Day 0 and 7
A qualitative assessment of the presence of fibrotic tissue in the extracellular matrix using a light field microscope.
Time frame: Day 0 and 7
A qualitative assessment of the presence and integrity of the basal membrane using a light field microscope.
Time frame: Day 0 and 7
A qualitative assessment of the presence of collagen fibers in the dermis using a light field microscope.
Time frame: Day 7
Clinical evaluation of wound's re-epithelization based on the judgement of an experienced plastic surgeon
Universidad Autonoma de Nuevo Leon
Other
Pirfenidone and Its Efficacy in Wound Re-Epithelization in Patients With Second-Degree Burns: A Proof-of-Concept Randomized Controlled Trial
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