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

Study Overview
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Brief Summary
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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
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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.

Official Title
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An Open Clinical Feasibility Study to Evaluate Efficacy and Safety of Soluble Beta-1,3/1,6-Glucan in Thermal Burns

Conditions
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Burns

Intervention / Treatment
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* Drug: Soluble beta-1,3/1,6-glucan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Soluble beta-1,3/1,6-glucan|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  |