Treatment of second degree burns with Flaminal® versus Flammazine®

Conditions: Patients with partial thickness burns and/ or mixed depth of partial and full thickness burns
MedDRA version: 14.1Level: LLTClassification code 10015723Term: Extensive burnsSystem Organ Class: 100000004863
MedDRA version: 14.1Level: LLTClassification code 10006796Term: Burns eyesSystem Organ Class: 100000004863
MedDRA version: 14.1Level: LLTClassification code 10006795Term: Burns extensiveSystem Organ Class: 100000004863
MedDRA version: 16.0Level: LLTClassification code 10006794Term: Burns classified according to extent of body surface involvedSystem Organ Class: 100000004863
MedDRA version: 14.1Level: LLTClassification code 10043441Term: Third degree burnsSystem Organ Class: 100000004863
MedDRA version: 14.1Level: LLTClassification code 10006801Term: Burns of multiple specified sites, unspecified degreeSystem Organ Class: 100000004863
MedDRA 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: 100000004863
MedDRA version: 14.1Level: LLTClassification code 10028175Term: Multiple burnsSystem Organ Class: 100000004863
MedDRA version: 14.1Level: LLTClassification code 10039798Term: Second degree burnsSystem Organ Class: 100000004863

Registration Number: EUCTR2013-000901-21-NL

Lead Sponsor: Rode Kruis Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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