BurnsPhase 2/3HeparinNCT00701623
Sodic Heparin Effectiveness of the Treatment of Burns
A Phase 2/3 study testing heparin and folder water in people with Burns, run by Azidus Brasil at 1 site in Brazil.
Trial 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 . Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Burns
- What is being tested?
- heparin and folder water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2008to Jun 2008
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 18Show fewer
- thrombocytopenia
- erosive gastro cases
- clinically relevant bleeding
- hypersensitivity to anticoagulants
- liver disease
- nephropathy
- diabetes
- 35
- serious allergy
- descontrole emotional
- pregnancy
- anemia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Burns
- Being tested
- heparin, folder water
- Keywords
- sodium heparin, burns of the skin
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
heparinDrug
patients will receive the application of one of two types of heparin directly on the injured area
heparinDrug
patients will receive the application of one of two types of heparin directly on the injured area
folder waterDrug
patients will receive the application of folder water directly on the injured area
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | patients treated with heparin Receives: Drug: heparin |
| 2 | Experimental | Patients treated with heparin Receives: Drug: heparin |
| 3 | Active comparator | patients treated with folder water directly on the injured area Receives: Drug: folder water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary: immediate decrease in pain. Secondary: analgesic request for 10 minutes after application of heparin, signs of intolerance and adverse events.
Measured: healing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azidus Brasil
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Azidus Brasil, Azidus Brasil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00701623
- Sponsor's protocol ID
- HEPCRI0208
- Acronym
- Heparin
- Status last verified
- Nov 2022
- First submitted
- 17 Jun 2008
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Product Alimax ® (Sodic Heparin) in Treatment of Burns: Comparative Study of Raw Materials Between Two Suppliers
- ClinicalTrials.gov ID
- NCT00701623
- Acronym / sponsor ID
- Heparin / HEPCRI0208
- Conditions
- Burns
- Keywords
- sodium heparin, burns of the skin
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Azidus BrasilIndustry (pharma, biotech, devices)
- Study start
- Jun 2008 (actual)
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 19 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: heparinpatients treated with heparin |
| 2 | Experimental | Drug: heparinPatients treated with heparin |
| 3 | Active comparator | Drug: folder waterpatients treated with folder water directly on the injured area |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| heparinpatients will receive the application of one of two types of heparin directly on the injured area | Drug | 1 |
| heparinpatients will receive the application of one of two types of heparin directly on the injured area | Drug | 2 |
| folder waterpatients will receive the application of folder water directly on the injured area | Drug | 3 |
Primary outcome
Primary: immediate decrease in pain. Secondary: analgesic request for 10 minutes after application of heparin, signs of intolerance and adverse events.
Time frame: healing
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing heparin and folder water in people with Burns, run by Azidus Brasil at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary: immediate decrease in pain. Secondary: analgesic request for 10 minutes after application of heparin, signs of intolerance and adverse events. (time frame: healing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022.