Clinical Efficacy of Product Alimax ® (Sodic Heparin) in Treatment of Burns: Comparative Study of Raw Materials Between Two Suppliers
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Primary: immediate decrease in pain. Secondary: analgesic request for 10 minutes after application of heparin, signs of intolerance and adverse events.
研究概览
简要总结
Burns are injuries caused by agents thermal, chemical, electrical or radioactive who act in the tissue lining of the human body and may partially or totally destroy the skin and its annexes, to the deeper layers, as subcutaneous tissue, muscles, tendons and bones .
Studies show that topical heparin has, in addition to the already known anticoagulant activity, anti-inflammatory properties, analgesic, and neoangiogenic, stimulating blood flow and increasing the repair of the fabric as well as the restoration of collagen and reepiteliztion. Moreover, the use of heparin reduces the need for painful medical procedures, as debridations, surgeries and transplants The intention of this work is to verify the effectiveness and safety of sodium heparin in the treatment of burns of the skin.
详细描述
Patients with burns that come to the emergency room will be informed about the
Inclusion Criteria
- Patients aged above 12 years who have suffered thermal burns of 2nd degree burns or mixed 2 and 3 degrees in up to 10% of body surface and indication of outpatient treatment.
Exclusion Criteria
- Area burned more than 10% of body surface
- the presence of the 3 rd degree burns
- burns in the face or genitals
- burns in poly-traumatized
- respiratory injury
- disorders of coagulation
- thrombocytopenia
- erosive gastro cases
- clinically relevant bleeding
- hypersensitivity to anticoagulants
- liver disease
- nephropathy
- diabetes
- 35
- serious allergy
- descontrole emotional
- pregnancy
- anemia
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged above 12 years who have suffered thermal burns of 2nd degree burns or mixed 2 and 3 degrees in up to 10% of body surface and indication of outpatient treatment.
排除标准
- •Area burned more than 10% of body surface
- •the presence of the 3 rd degree burns
- •burns in the face or genitals
- •burns in poly-traumatized
- •respiratory injury
- •disorders of coagulation
- •thrombocytopenia
- •erosive gastro cases
- •clinically relevant bleeding
- •hypersensitivity to anticoagulants
- •liver disease
- •nephropathy
- •serious allergy
- •descontrole emotional
- •pregnancy
研究组 & 干预措施
1
patients treated with heparin
干预措施: heparin (Drug)
2
Patients treated with heparin
干预措施: heparin (Drug)
3
patients treated with folder water directly on the injured area
干预措施: folder water (Drug)
结局指标
主要结局
Primary: immediate decrease in pain. Secondary: analgesic request for 10 minutes after application of heparin, signs of intolerance and adverse events.
时间窗: healing
次要结局
未报告次要终点
研究者
Azidus Brasil
Principal Investigator Dr. Alexandre Frederico
Azidus Brasil