Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2025-12-25 @ 2:42 PM
Study NCT ID:
NCT03530150
Status:
COMPLETED
Last Update Posted:
2018-05-21
First Post:
2018-05-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pirfenidone and Its Role in Burn Wound Healing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002056', 'term': 'Burns'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The principal investigator, the person in charge of gathering the data, and the person analyzing the data will be blinded'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Burn patients will be divided to receive either 600 mg of pirfenidone or usual care'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2017-06-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-17', 'studyFirstSubmitDate': '2018-05-07', 'studyFirstSubmitQcDate': '2018-05-17', 'lastUpdatePostDateStruct': {'date': '2018-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Epidermal re-epithelization', 'timeFrame': 'Day 7', 'description': 'Thickness of the epidermal re-epithelization measured in micrometers using a digitial image software'}], 'secondaryOutcomes': [{'measure': 'Presence of Fibrosis', 'timeFrame': 'Day 0 and 7', 'description': 'A qualitative assessment of the presence of fibrotic tissue in the extracellular matrix using a light field microscope.'}, {'measure': 'Basal Membrane Integrity', 'timeFrame': 'Day 0 and 7', 'description': 'A qualitative assessment of the presence and integrity of the basal membrane using a light field microscope.'}, {'measure': 'Presence of Collagen Fibers', 'timeFrame': 'Day 0 and 7', 'description': 'A qualitative assessment of the presence of collagen fibers in the dermis using a light field microscope.'}, {'measure': "Clinical Evaluations of Wound's Re-Epithelization", 'timeFrame': 'Day 7', 'description': "Clinical evaluation of wound's re-epithelization based on the judgement of an experienced plastic surgeon"}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Burns', 'Partial-thickness burn wounds', 'Re-epithelization', 'Second-Degree Wound', 'Pirfenidone', 'Wound Healing'], 'conditions': ['Second-degree Burn']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with second-degree burns from any etiology with less than 24 hours of evolution.\n\nExclusion Criteria:\n\n* Patients \\<18 years old\n* Patients allergic to pirfenidone\n* Pregnant patients\n* Patients with renal or hepatic failure\n* Patients who are not able to take the medication orally\n* Conditions or drugs that alter wound healing (i.e. any kind of diabetes, lupus, having a history of using steroids, rheumatoid arthritis)'}, 'identificationModule': {'nctId': 'NCT03530150', 'briefTitle': 'Pirfenidone and Its Role in Burn Wound Healing', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Autonoma de Nuevo Leon'}, 'officialTitle': 'Pirfenidone and Its Efficacy in Wound Re-Epithelization in Patients With Second-Degree Burns: A Proof-of-Concept Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'CP14-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pirfenidone 600 mg', '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.', 'interventionNames': ['Drug: Pirfenidone Oral Product']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care', '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.'}], 'interventions': [{'name': 'Pirfenidone Oral Product', 'type': 'DRUG', 'otherNames': ['Kitoscell'], 'description': 'A pill containing 600 mg of pirfenidone', 'armGroupLabels': ['Pirfenidone 600 mg']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Gabriel A Mecott-Rivera, MMS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad Autonoma de Nuevo Leon'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'Data will be available from May 2018 to May 2020', 'ipdSharing': 'YES', 'description': 'All information will be delivered by request.\n\nPossible individual participant data includes:\n\nDatabase Original Protocol Informed Consent'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Autonoma de Nuevo Leon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Gabriel Angel Mecott-Rivera', 'investigatorAffiliation': 'Universidad Autonoma de Nuevo Leon'}}}}