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
  Purpose

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 Intervention Phase
Burns
Drug: Soluble beta-1,3/1,6-glucan
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Biotec Pharmacon ASA:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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

Estimated Enrollment: 10
Study Start Date: January 2006
Estimated Study Completion Date: March 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00283426

Locations
Norway
Haukeland University Hospital
Bergen, Norway, 5021
Sponsors and Collaborators
Biotec Pharmacon ASA
Investigators
Principal Investigator: Tjostolv Lund, Dr.med. Haukeland University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00283426     History of Changes
Other Study ID Numbers: SBG-1-10
Study First Received: January 27, 2006
Last Updated: March 16, 2007
Health Authority: Norway: Norwegian Medicines Agency

Additional relevant MeSH terms:
Burns
Wounds and Injuries

ClinicalTrials.gov processed this record on July 26, 2014