Sodic Heparin Effectiveness of the Treatment of Burns

Burns Clinical Trial

— Heparin  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00701623
• Other study ID #: HEPCRI0208
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• 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
• 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• Status: Withdrawn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

Related Conditions & MeSH terms

• Burns

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