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Sodic Heparin Effectiveness of the Treatment of Burns

Information source: L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Burns

Intervention: heparin (Drug); heparin (Drug); folder water (Drug)

Phase: Phase 2/Phase 3

Status: Withdrawn

Sponsored by: L.A.L Clinica Pesquisa e Desenvolvimento Ltda.

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Primary: immediate decrease in pain. Secondary: analgesic request for 10 minutes after application of heparin, signs of intolerance and adverse events.

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

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

LAL Clinica PPesquisa e Desenvolvimento, Valinhos, Sao Paulo, Brazil
Additional Information

Starting date: June 2008
Last updated: October 26, 2010

Page last updated: August 23, 2015

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