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Keep this study
Lead
Molnlycke Health Care AB
In- and/or out-patients at ten centers in the United States were included in this investigation. Subjects included were 5 years of age and older who suffered from partial thickness burns. Every patient was followed for 3 weeks.
Age
5–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patients with a second degree burn covering 5% to 20% BSA. TBSA covered with burn is allowed to be up to 25%, allowing a maximum of 10% to be third degree burn (only the Second degree burn should be treated)
Burn of thermal origin
Both gender with an age ≥ 5 years at randomization
Signed informed consent
Subjects who are younger than the legal consenting age must have a legally authorized representative
You may not be if
\- Burns equal to or older than 36 hours
Burns of chemical and electrical origin
Clinically infected Burn (as judged by the investigator)
Treatment of the burn with an active agent before study entry, SSD is allowed up to 24 hours prior to randomization
Patients with necrotising leucocytic vasculitis or pyoderma gangrenosa.
Diagnosed underlying disease(s) (e.g. HIV/AIDS, cancer and severe anaemia) judged by the investigator to be a potential interference in the treatment.
Patients with insulin dependent diabetes mellitus
Patients treated with systemic glucocorticosteroids, except patients taking occasional doses or doses less than 10mg prednisolon/day or equivalent.
Use of immunosuppressive agents, radiation or chemotherapy within the past 30 days.
Known allergy/hypersensitivity to any of the components of the investigation products.
Patients with physical and/or mental conditions that are not expected to comply with the investigation.
Participation in other clinical investigation(s) within 1 month prior to start of the investigation