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

• Status: Terminated
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: All

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: Soluble beta-1,3/1,6-glucan will through its immunomodulating activities improve wound healing of thermal burns and non-injured skin where skin grafts are harvested.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biotec Pharmacon ASA

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