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Sponsors and Collaborators: |
Association of Dutch Burn Centres Dutch Burns Foundation |
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Information provided by: | Association of Dutch Burn Centres |
ClinicalTrials.gov Identifier: | NCT00156988 |
The objective of the proposed study is to assess whether the application of flammacerium for 2 days is as good as, or even better than, the application of flammacerium for 10 days regarding woundhealing in partial thickness burns.
Condition | Intervention | Phase |
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Burns |
Drug: cerium nitrate-silver sulfadiazine (cerium-flamazine) |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | The Effect of Two Versus Ten Days Application of Flammacerium in Partial Thickness Burns |
Study Start Date: | March 2004 |
Estimated Study Completion Date: | December 2005 |
Cerium is suggested to halt the cytokine cascade ensuing burn injury by binding the 'burn toxin' and, when used in combination with silver-sulfadiazine, may enhance its antibacterial effect. Since 1984, the combination of cerium and silver sulfadiazine, flammacerium, has been used in our centre. Current practice is to treat acute, non-facial, burns with daily cleaning and (re-)application of flammacerium for a total of ten days. However, prolonged application of cerium is thought to be unnecessary - it is effective in the early stages after injury- and prolonged application of silver sulfadiazine has a negative effect on wound healing. The objective of the proposed study is therefore, to assess whether the application of flammacerium for 2 days is as good as, or even better than, the application of flammacerium for 10 days regarding woundhealing in partial thickness burns.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Netherlands | |
Burns Centre, Martini Hospital | |
Groningen, Netherlands, 9728NZ |
Principal Investigator: | Marianne K Nieuwenhuis, PhD | Association Dutch Burns Centres |
Study ID Numbers: | WO/P04.103, WO/P04.103 |
Study First Received: | September 8, 2005 |
Last Updated: | August 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00156988 History of Changes |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
burns partial thickness cerium flamazine randomised clinical trial |
Burns Anti-Infective Agents Anti-Infective Agents, Local Silver Sulfadiazine |
Wounds and Injuries Disorders of Environmental Origin Sulfadiazine Cerium nitrate |
Burns Anti-Infective Agents Antiprotozoal Agents Silver Sulfadiazine Wounds and Injuries Disorders of Environmental Origin Pharmacologic Actions |
Anti-Infective Agents, Local Antiparasitic Agents Therapeutic Uses Sulfadiazine Coccidiostats Cerium nitrate |