Sodic Heparin Effectiveness of the Treatment of Burns

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Clinical Efficacy of Product Alimax ® (Sodic Heparin) in Treatment of Burns: Comparative Study of Raw Materials Between Two Suppliers

Conditions
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Burns

Intervention / Treatment
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* Drug: heparin
* Drug: heparin
* Drug: folder water


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>patients treated with heparin | Drug: heparin<br>* patients will receive the application of one of two types of heparin directly on the injured area<br>|
| Experimental: 2<br>Patients treated with heparin | Drug: heparin<br>* patients will receive the application of one of two types of heparin directly on the injured area<br>|
| Active Comparator: 3<br>patients treated with folder water directly on the injured area | Drug: folder water<br>* patients will receive the application of folder water directly on the injured area<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary: immediate decrease in pain. Secondary: analgesic request for 10 minutes after application of heparin, signs of intolerance and adverse events. |  | healing | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sodium heparin, burns of the skin