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Sodic Heparin Effectiveness of the Treatment of Burns

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

Status
Withdrawn
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00701623
Acronym
Heparin
Enrollment
0
Registered
2008-06-19
Start date
2008-06-30
Completion date
2008-06-30
Last updated
2022-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burns

Keywords

sodium heparin, burns of the skin

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.

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

Interventions

DRUGheparin

patients will receive the application of one of two types of heparin directly on the injured area

DRUGfolder water

patients will receive the application of folder water directly on the injured area

Sponsors

Azidus Brasil
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026