Sodic Heparin Effectiveness of the Treatment of Burns (SODIC HEPARIN)

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier:
NCT00701623
First received: June 17, 2008
Last updated: October 26, 2010
Last verified: February 2008
  Purpose

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.


Condition Intervention Phase
Burns
Drug: heparin
Drug: folder water
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Efficacy of Product Alimax ® (Sodic Heparin) in Treatment of Burns: Comparative Study of Raw Materials Between Two Suppliers

Resource links provided by NLM:


Further study details as provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:

Primary Outcome Measures:
  • Primary: immediate decrease in pain. Secondary: analgesic request for 10 minutes after application of heparin, signs of intolerance and adverse events. [ Time Frame: healing ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 84
Study Start Date: June 2008
Estimated Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
patients treated with heparin
Drug: heparin
patients will receive the application of one of two types of heparin directly on the injured area
Experimental: 2
Patients treated with heparin
Drug: heparin
patients will receive the application of one of two types of heparin directly on the injured area
Active Comparator: 3
patients treated with folder water directly on the injured area
Drug: folder water
patients will receive the application of folder water directly on the injured area

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

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00701623

Locations
Brazil
LAL Clinica PPesquisa e Desenvolvimento
Valinhos, Sao Paulo, Brazil
Sponsors and Collaborators
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
  More Information

No publications provided

Responsible Party: Alexandre Frederico, LAL Clinica
ClinicalTrials.gov Identifier: NCT00701623     History of Changes
Other Study ID Numbers: HEPCRI0208
Study First Received: June 17, 2008
Last Updated: October 26, 2010
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:
The intention of this work is to verify the effectiveness and safety of sodium heparin in the treatment of burns of the skin.

Additional relevant MeSH terms:
Burns
Wounds and Injuries
Calcium heparin
Heparin
Anticoagulants
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014