Sodic Heparin Effectiveness of the Treatment of Burns

Azidus

Status and phase: Withdrawn; Phase 3; Phase 2

Conditions: Burns

Treatments: Drug: folder water; Drug: heparin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00701623

HEPCRI0208

Details and patient eligibility

About

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.

Full description

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

Sex: All

Ages: 12+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 3 patient groups

1

Experimental group

Description:

patients treated with heparin

Treatment:

Drug: heparin

Drug: heparin

2

Experimental group

Description:

Patients treated with heparin

Treatment:

Drug: heparin

Drug: heparin

3

Active Comparator group

Description:

patients treated with folder water directly on the injured area

Treatment:

Drug: folder water