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

Sponsored by:	Biotec Pharmacon ASA
Information provided by:	Biotec Pharmacon ASA
ClinicalTrials.gov Identifier:	NCT00283426

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 I

MedlinePlus related topics: Burns

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open Clinical Feasibility Study to Evaluate Efficacy and Safety of Soluble Beta-1,3/1,6-Glucan in Thermal Burns

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

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

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

Study placed in the following topic categories:

Burns
Wounds and Injuries
Disorders of Environmental Origin

ClinicalTrials.gov processed this record on January 16, 2009