Sodic Heparin Effectiveness of the Treatment of Burns - Full Text View

Sponsored by:	L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
Information provided by:	L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier:	NCT00701623

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 II Phase III

MedlinePlus related topics: Blood Thinners Burns Drinking Water

Drug Information available for: Heparin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Clinical Efficacy of Product Alimax ® (Sodic Heparin) in Treatment of Burns: Comparative Study of Raw Materials Between Two Suppliers

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
1: Experimental patients treated with heparin	Drug: heparin patients will receive the application of one of two types of heparin directly on the injured area
2: Experimental Patients treated with heparin	Drug: heparin patients will receive the application of one of two types of heparin directly on the injured area
3: Active Comparator 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

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

Contacts

Contact: Alexandre Frederico, Investigator

55-19-3829-3822

dr.alexandre.@lalclinica.com.br

Locations

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

Sponsors and Collaborators

L.A.L Clinica Pesquisa e Desenvolvimento Ltda.

More Information

Responsible Party:	LAL Clinica ( Alexandre Frederico )
Study ID Numbers:	HEPCRI0208
Study First Received:	June 17, 2008
Last Updated:	June 18, 2008
ClinicalTrials.gov Identifier:	NCT00701623
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.

Study placed in the following topic categories:

Burns
Calcium, Dietary
Wounds and Injuries

Disorders of Environmental Origin
Heparin
Calcium heparin

Additional relevant MeSH terms:

Fibrin Modulating Agents
Anticoagulants
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Hematologic Agents
Fibrinolytic Agents
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009