Sodic Heparin Effectiveness of the Treatment of Burns | NCT00701623

Studies
Sodic Heparin Effectiveness of the Treatment of Burns

NCT00701623

Sponsor

Azidus Brasil

Status

Withdrawn

Last Update Posted

Nov 3, 2022Actual

Enrollment

0Actual

Phase

Phase 2Phase 3

Conditions

Burns

Interventions

heparin
heparin
folder water

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2022

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2008Actual

Primary Completion Date

Jun 2008Actual

Completion Date

Jun 2008Actual

First Submitted Date

Jun 17, 2008

First Submission Date that Met QC Criteria

Jun 18, 2008

First Posted Date

Jun 19, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 1, 2022

Last Update Posted Date

Nov 3, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Azidus Brasil, Principal Investigator Dr. Alexandre Frederico, Azidus BrasilPrincipal Investigator

Lead Sponsor

Azidus BrasilINDUSTRY

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	patients treated with heparin	Drug: heparin
2	Experimental	Patients treated with heparin	Drug: heparin
3	Active Comparator	patients treated with folder water directly on the injured area	Drug: folder water

Interventions

Name	Type	Description	Arm Group Labels	Other Names
heparin	Drug	patients will receive the application of one of two types of heparin directly on the injured area	1

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
LAL Clinica PPesquisa e Desenvolvimento		Valinhos	São Paulo		Brazil

Condition Browse Module

MeSH Terms

ID	Term
D002056	Burns

Ancestor Terms

ID	Term
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006493	Heparin

Ancestor Terms

ID	Term
D006025	Glycosaminoglycans
D011134	Polysaccharides
D002241	Carbohydrates

Browse Leaves

Not provided

Browse Branches

Not provided