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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00701623
Other study ID # HEPCRI0208
Secondary ID
Status Withdrawn
Phase Phase 2/Phase 3
First received
Last updated
Start date June 2008
Est. completion date June 2008

Study information

Verified date November 2022
Source Azidus Brasil
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date June 2008
Est. primary completion date June 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
heparin
patients will receive the application of one of two types of heparin directly on the injured area
heparin
patients will receive the application of one of two types of heparin directly on the injured area
folder water
patients will receive the application of folder water directly on the injured area

Locations

Country Name City State
Brazil LAL Clinica PPesquisa e Desenvolvimento Valinhos Sao Paulo

Sponsors (1)

Lead Sponsor Collaborator
Azidus Brasil

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Primary: immediate decrease in pain. Secondary: analgesic request for 10 minutes after application of heparin, signs of intolerance and adverse events. healing
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