Efficacy and Safety Study of Soluble Beta-1,3/1,6-Glucan in Thermal Burns

Launched by BIOTEC PHARMACON ASA · Jan 27, 2006

Keywords

ClinConnect Summary

In severe cases, burn patients commonly exhibit a clinical picture of systemic inflammation with a variety of manifestations ranging from the presence of tachycardia, tachypnea, fever and leukocytosis, and may progress to refractory hypotension. Shock and multiple organ system dysfunction may subsequently occur. Sepsis, caused by infection or bacteremia, is also a common occurrence and a major complication in burn patients.

After cooling the burned area, pain control is important. Local burn wound care starts with cleansing the wound followed by application of topical agents to prevent inf...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • age \>= 18 years
• • written informed consent
• • Group A - patients with thermal burns
• • partial thickness burns (2nd degree) requiring non-surgical primary treatment
• • primarily 5-15% TBSA burns, but burn patients with injury size from 1 to 40% TBSA may be included
• • or
• • Group B - patients with thermal burns
• • non-grafted partial thickness burns (2nd degree) in patients requiring autotransplantation in the early phase
• • primarily 5-15% TBSA burns, but burn patients with injury size from 1 to 40% TBSA may be included
• • or
• • Group C - patients with thermal burns
• • donor site(s) on the ventral side of the body and limbs in deep partial thickness burns (2nd degree) and/or full thickness burns patients requiring autotransplantation during the first 1-3 weeks after injury
• • primarily 5-15% TBSA burns, but burn patients with injury size from 1 to 40% TBSA may be included
• Exclusion Criteria:
• • inhalation injury to airways and lungs
• • chemical or high voltage electrical burn
• • pregnancy, lactation
• • clinical signs or symptoms of acute infection
• • any prescription or non-prescription topical medication administered within one week prior to study start
• • hematological and clinical/chemical parameteres judged as unacceptable by the investigator
• • donor sites with re-harvesting
• • previous treatment with soluble beta-1,3/1,6-glucan
• • participation in other clinical studies in the last 4 weeks