Sodic Heparin Effectiveness of the Treatment of Burns

Phase 2

Withdrawn

• Conditions: Burns
• Interventions: Drug: heparin; Drug: folder water

• Registration Number: NCT00701623
• Lead Sponsor: Azidus Brasil

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

Study Timeline

• Study Start: 2008-06
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Study First Submitted: 2008-06-17
• Study First Submitted QC: 2008-06-18
• Study First Posted: 2008-06-19
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-01
• Last Update Posted: 2022-11-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	heparin	Patients treated with heparin
3	folder water	patients treated with folder water directly on the injured area
1	heparin	patients treated with heparin

Primary Outcome Measures

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

Trial Locations

Locations (1)

LAL Clinica PPesquisa e Desenvolvimento; 🇧🇷 Valinhos, Sao Paulo, Brazil