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

NCT00283426 | Terminated Phase 1

• 1 other identifier: SBG-1-10
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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: 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.

Conditions

Burns

Outcome Measures

Primary Outcomes (14)

• Efficacy parameters:

• oedema

• bleeding

• pain on physical contact

• exudation

• capillary refill

• reepithelialization

• rubor

• paleness

• infectious discharge

• smell

• adherence of dressing

• time since last dressing change

• The efficacy parameters will be recorded during regular wound procedures

Secondary Outcomes (5)

• Safety parameters:

• vital signs (heart rate, blood pressure, body temperature)

• adverse events

• laboratory parameters

• The safety parameters will be recorded daily during the first week of treatment and weekly thereafter

Interventions

Soluble beta-1,3/1,6-glucan DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biotec Pharmacon ASA: lead

Study Sites (1)

Haukeland University Hospital

Bergen, 5021, Norway

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Tjostolv Lund, Dr.med.

  Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 27, 2006
• First Posted: January 30, 2006
• Study Start: January 1, 2006
• Study Completion: March 1, 2007
• Last Updated: March 19, 2007

Record last verified: 2007-03

Locations

NO (1)