An Open Clinical Feasibility Study to Evaluate Efficacy and Safety of Soluble Beta-1,3/1,6-Glucan in Thermal Burns
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Efficacy parameters:
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Efficacy parameters:
oedema
bleeding
time since last dressing change
The efficacy parameters will be recorded during regular wound procedures
pain on physical contact
exudation
capillary refill
reepithelialization
rubor
paleness
infectious discharge
smell
adherence of dressing
次要结局
- 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