Septic burns.
Conditions
Interventions
One single group will have lesions treated with Dermofural ointment once a day, after bandage removal and wound bath. Depending on the patient’s clinical and microbiological evolution, Dermofural can
Anti-Bacterial Agents
Anti-Infective Agents
Dermofural
Sponsors
Center for Genetic Engineering and Biotechnology (CIGB)
Chemical Bioactive Center. ''Marta Abreu'' Central University of Las Villas
Eligibility
Sex/Gender
All
Age
16 Years to 60 Years
Inclusion criteria
Inclusion criteria: Cuban patients, of both sexes and any race, with burns type A, AB or B, classified as slight, moderate or serious, requiring occlusion. Presence of sepsis, microbiologically confirmed in lesions, caused by Pseudomonas aeruginosa or any other bacterial agents. Patients aged 16 to 60. Burns by physical agents. Patient’s Informed Consent in writing to participate in the trial and undergo relevant tests.
Exclusion criteria
Exclusion criteria: Burns by electrical or chemical agents, inhalation, or both. Burns in anal and genital region, and face. Systemic or topical anti-microbial required. Patients who have been on steroid treatment in the last 3 months (any administration route). History of allergy or hypersensitivity to any formulation component. Diabetes mellitus. Immune disease diagnosed. Malignant neoplasia. Chronic kidney failure or liver disorder. Collagen disease. Pregnancy, breastfeeding or puerperium. Severe psychiatric disorder or mental handicap.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment safety, measuring time: 28 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical and microbiological response to sepsis, measuring time: 28 days. Negative microbiological test, measuring time: 28 days. Sepsis elimination, measuring time: 28 days. Lesion cicatrization: measuring time: 28 days. Lesion size: measuring time: 28 days | — |
Countries
Cuba
Contacts
Public ContactIdrian Garcia Garcia
Clinical Trials Division, Center for Biological Research
Outcome results
None listed