EUCTR2013-000901-21-NL
Active, not recruiting
Not Applicable
A randomized clinical trial on the effectiveness, cost-effectiveness and quality of life of Flaminal® versus Flammazine® in the treatment of superficial and deep partial thickness burns - Flam study
Rode Kruis Ziekenhuis0 sitesJune 6, 2013
ConditionsPatients with partial thickness burns and/ or mixed depth of partial and full thickness burnsMedDRA version: 14.1Level: LLTClassification code 10015723Term: Extensive burnsSystem Organ Class: 100000004863MedDRA version: 14.1Level: LLTClassification code 10006796Term: Burns eyesSystem Organ Class: 100000004863MedDRA version: 14.1Level: LLTClassification code 10006795Term: Burns extensiveSystem Organ Class: 100000004863MedDRA version: 16.0Level: LLTClassification code 10006794Term: Burns classified according to extent of body surface involvedSystem Organ Class: 100000004863MedDRA version: 14.1Level: LLTClassification code 10043441Term: Third degree burnsSystem Organ Class: 100000004863MedDRA version: 14.1Level: LLTClassification code 10006801Term: Burns of multiple specified sites, unspecified degreeSystem Organ Class: 100000004863MedDRA version: 16.0Level: LLTClassification code 10012087Term: Deep necrosis of underlying tissues due to burns (dtd) of multiple specified sites w/o mention lobpSystem Organ Class: 100000004863MedDRA version: 14.1Level: LLTClassification code 10028175Term: Multiple burnsSystem Organ Class: 100000004863MedDRA version: 14.1Level: LLTClassification code 10039798Term: Second degree burnsSystem Organ Class: 100000004863MedDRA version: 16.0Level: LLTClassification code 10031700Term: Other burns of eyelids and periocular areaSystem Organ Class: 100000004863Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
DrugsFlammazine®
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Patients with partial thickness burns and/ or mixed depth of partial and full thickness burns
- Sponsor
- Rode Kruis Ziekenhuis
- Status
- Active, not recruiting
- Last Updated
- 12 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Competent or temporary incompetent (because of sedation and/ or intubation) patients with partial thickness burns and/ or mixed depth of partial and full thickness burns
- •\- Hospital admission within 48 hour of burn injury
- •\- Written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 80
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 10
Exclusion Criteria
- •\- Age \< 18 years
- •\- Total body surface area (TBSA) of \> 20%
- •\- Burns caused by chemicals, electricity or radiation
- •\- Patients in whom local therapy with a topical agent has already started
- •\- Patients who are expected (according to the responsible medical doctor) to be non\-compliant to the study protocol
Outcomes
Primary Outcomes
Not specified
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