Sodic Heparin Effectiveness of the Treatment of Burns

NCT ID: NCT00701623

Last Updated: 2022-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2008-06-30

Brief Summary

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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

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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

Conditions

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Burns

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

patients treated with heparin

Group Type EXPERIMENTAL

heparin

Intervention Type DRUG

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

2

Patients treated with heparin

Group Type EXPERIMENTAL

heparin

Intervention Type DRUG

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

3

patients treated with folder water directly on the injured area

Group Type ACTIVE_COMPARATOR

folder water

Intervention Type DRUG

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

Interventions

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heparin

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

Intervention Type DRUG

heparin

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

Intervention Type DRUG

folder water

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Azidus Brasil

INDUSTRY

Sponsor Role lead

Responsible Party

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Azidus Brasil

Principal Investigator Dr. Alexandre Frederico

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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LAL Clinica PPesquisa e Desenvolvimento

Valinhos, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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HEPCRI0208

Identifier Type: -

Identifier Source: org_study_id

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