Sodic Heparin Effectiveness of the Treatment of Burns
Heparin
Clinical Efficacy of Product Alimax ® (Sodic Heparin) in Treatment of Burns: Comparative Study of Raw Materials Between Two Suppliers
1 other identifier
interventional
N/A
1 country
1
Brief 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.
Trial Health
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Started Jun 2008
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 17, 2008
CompletedFirst Posted
Study publicly available on registry
June 19, 2008
CompletedNovember 3, 2022
November 1, 2022
Same day
June 17, 2008
November 1, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary: immediate decrease in pain. Secondary: analgesic request for 10 minutes after application of heparin, signs of intolerance and adverse events.
healing
Study Arms (3)
1
EXPERIMENTALpatients treated with heparin
2
EXPERIMENTALPatients treated with heparin
3
ACTIVE COMPARATORpatients treated with folder water directly on the injured area
Interventions
patients will receive the application of one of two types of heparin directly on the injured area
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- serious allergy
- descontrole emotional
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Azidus Brasillead
Study Sites (1)
LAL Clinica PPesquisa e Desenvolvimento
Valinhos, São Paulo, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator Dr. Alexandre Frederico
Study Record Dates
First Submitted
June 17, 2008
First Posted
June 19, 2008
Study Start
June 1, 2008
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
November 3, 2022
Record last verified: 2022-11