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

This study has been terminated.
(Slow patient recruitment)
Sponsor:
Information provided by:
Biotec Pharmacon ASA
ClinicalTrials.gov Identifier:
NCT00283426
First received: January 27, 2006
Last updated: March 16, 2007
Last verified: March 2007

January 27, 2006
March 16, 2007
January 2006
Not Provided
  • 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
Same as current
Complete list of historical versions of study NCT00283426 on ClinicalTrials.gov Archive Site
  • 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
  • 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
Not Provided
Not Provided
 
Efficacy and Safety Study of Soluble Beta-1,3/1,6-Glucan in Thermal Burns
An Open Clinical Feasibility Study to Evaluate Efficacy and Safety of Soluble Beta-1,3/1,6-Glucan in Thermal Burns

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.

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 infection. Such agents may have adverse local or systemic effects and may impede on the wound healing process itself. The use of synthetic or biologic materials for wound covering is becoming increasingly popular, but most of the clinical information about efficacy of such products are anecdotal.

A primary objective in burn care is to have all wounds healed within 1 month. With longer healing periods, there is an increasing likelihood of developing hypertropic scaring and alterations in pigmentation. The development of an effective wound healing agent would therefore be highly beneficial for the suffering patient in terms of decreased healing time and improved cosmetic results.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Burns
Drug: Soluble beta-1,3/1,6-glucan
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
10
March 2007
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00283426
SBG-1-10
Not Provided
Not Provided
Biotec Pharmacon ASA
Not Provided
Principal Investigator: Tjostolv Lund, Dr.med. Haukeland University Hospital
Biotec Pharmacon ASA
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP