Clinical trial NCT00283426: Efficacy and Safety Study of Soluble Beta-1,3/1,6-Glucan in Thermal Burns
Official title: An Open Clinical Feasibility Study to Evaluate Efficacy and Safety of Soluble Beta-1,3/1,6-Glucan in Thermal Burns
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Burns
Lead sponsor: Biotec Pharmacon ASA
Sponsor class: INDUSTRY
First posted: 2006-01-30
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Efficacy parameters:
measure: oedema
measure: bleeding
measure: pain on physical contact
measure: exudation
measure: capillary refill
measure: reepithelialization
measure: rubor
measure: paleness
measure: infectious discharge
measure: smell
measure: adherence of dressing
measure: time since last dressing change
measure: The efficacy parameters will be recorded during regular wound procedures
Secondary outcomes:
measure: Safety parameters:
measure: vital signs (heart rate, blood pressure, body temperature)
measure: adverse events
measure: laboratory parameters
measure: The safety parameters will be recorded daily during the first week of treatment and weekly thereafter
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
Study officials:
affiliation: Haukeland University Hospital
name: Tjostolv Lund, Dr.med.
role: PRINCIPAL_INVESTIGATOR
References: