Status:
TERMINATED
Efficacy and Safety Study of Soluble Beta-1,3/1,6-Glucan in Thermal Burns
Lead Sponsor:
Biotec Pharmacon ASA
Conditions:
Burns
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine whether soluble beta-1,3/1,6-glucan is an effective and safe treatment of thermal burns and non-injured skin where skin grafts are harvested. Hypothesis: Sol...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
End Date :
March 1 2007
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00283426
Start Date
January 1 2006
End Date
March 1 2007
Last Update
March 19 2007
Active Locations (1)
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1
Haukeland University Hospital
Bergen, Norway, 5021