Clinical trial NCT00701623: Sodic Heparin Effectiveness of the Treatment of Burns
Official title: Clinical Efficacy of Product Alimax ® (Sodic Heparin) in Treatment of Burns: Comparative Study of Raw Materials Between Two Suppliers
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Burns
Keywords: sodium heparin
burns of the skin
Lead sponsor: Azidus Brasil
Sponsor class: INDUSTRY
First posted: 2008-06-19
Enrollment: 0
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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

Eligibility criteria: 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

Primary outcomes:
measure: Primary: immediate decrease in pain. Secondary: analgesic request for 10 minutes after application of heparin, signs of intolerance and adverse events.
timeFrame: healing
Secondary outcomes:
Other outcomes:
Locations:
city: Valinhos
country: Brazil
facility: LAL Clinica PPesquisa e Desenvolvimento
state: Sao Paulo
Study officials:
References: