Sodic Heparin Effectiveness of the Treatment of Burns (Heparin)

November 1, 2022 updated by: Azidus Brasil

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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

Study Type

Interventional

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azidus Brasil

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2008

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

June 17, 2008

First Submitted That Met QC Criteria

June 18, 2008

First Posted (Estimate)

June 19, 2008

Study Record Updates

Last Update Posted (Actual)

November 3, 2022

Last Update Submitted That Met QC Criteria

November 1, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HEPCRI0208

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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