Back to results

Sodic Heparin Effectiveness of the Treatment of Burns (Heparin)

Primary Purpose

Burns

Status

Withdrawn

Phase

Phase 2

Locations

Brazil

Study Type

Interventional

Intervention

heparin

folder water

About this trial

This is an interventional treatment trial for Burns focused on measuring sodium heparin, burns of the skin

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

LAL Clinica PPesquisa e Desenvolvimento

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

patients treated with heparin

Patients treated with heparin

patients treated with folder water directly on the injured area

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00701623

First Posted

June 17, 2008

Last Updated

November 1, 2022

Sponsor

Azidus Brasil

1. Study Identification

Unique Protocol Identification Number

NCT00701623

Brief Title

Sodic Heparin Effectiveness of the Treatment of Burns

Acronym

Heparin

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Withdrawn

Study Start Date

June 2008 (Actual)

Primary Completion Date

June 2008 (Actual)

Study Completion Date

June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Azidus Brasil

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Burns

Keywords

sodium heparin, burns of the skin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

patients treated with heparin

Arm Title

Arm Type

Experimental

Arm Description

Patients treated with heparin

Arm Title

Arm Type

Active Comparator

Arm Description

patients treated with folder water directly on the injured area

Intervention Type

Drug

Intervention Name(s)

heparin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

heparin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

folder water

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

healing

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

LAL Clinica PPesquisa e Desenvolvimento

City

Valinhos

State/Province

Sao Paulo

Country

Brazil

12. IPD Sharing Statement

Learn more about this trial

Sodic Heparin Effectiveness of the Treatment of Burns

We'll reach out to this number within 24 hrs