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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00283426
Recruitment Status : Terminated (Slow patient recruitment)
First Posted : January 30, 2006
Last Update Posted : March 19, 2007
Information provided by:
Biotec Pharmacon ASA

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.

Condition or disease Intervention/treatment Phase
Burns Drug: Soluble beta-1,3/1,6-glucan Phase 1

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, 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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Clinical Feasibility Study to Evaluate Efficacy and Safety of Soluble Beta-1,3/1,6-Glucan in Thermal Burns
Study Start Date : January 2006
Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

Primary Outcome Measures :
  1. Efficacy parameters:
  2. oedema
  3. bleeding
  4. pain on physical contact
  5. exudation
  6. capillary refill
  7. reepithelialization
  8. rubor
  9. paleness
  10. infectious discharge
  11. smell
  12. adherence of dressing
  13. time since last dressing change
  14. The efficacy parameters will be recorded during regular wound procedures

Secondary Outcome Measures :
  1. Safety parameters:
  2. vital signs (heart rate, blood pressure, body temperature)
  3. adverse events
  4. laboratory parameters
  5. The safety parameters will be recorded daily during the first week of treatment and weekly thereafter

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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


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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00283426

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Haukeland University Hospital
Bergen, Norway, 5021
Sponsors and Collaborators
Biotec Pharmacon ASA
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Principal Investigator: Tjostolv Lund, Haukeland University Hospital
Layout table for additonal information Identifier: NCT00283426    
Other Study ID Numbers: SBG-1-10
First Posted: January 30, 2006    Key Record Dates
Last Update Posted: March 19, 2007
Last Verified: March 2007
Additional relevant MeSH terms:
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Wounds and Injuries