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
Burns	Drug: cerium nitrate-silver sulfadiazine (cerium-flamazine)	Phase IV

Further Study Details: 

Primary Outcomes: number of days required for wound healing, judged clinically and assessed as both number of days till 95% and 100% re-epithelialisation by planimetry at the time the decision regarding surgery is made (8-10 pb) and as wounds are considered healed
Secondary Outcomes: Wound colonisation, assessed by swabs taken at 0 or 3 days pb, 7 days pb and subsequently every 7 days until wounds are healed or treated surgically, and on indication

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

Criteria

Inclusion Criteria:

• patients having partial thickness burns with TBSA of < 10%

Exclusion Criteria:

• patients not seen within 24 hours postburn
• patients with only facial burns
• patients with electrical or chemical burns
• patients or their parents/caregivers with mental or cognitive deficits that may interfere with providing informed consent

Please refer to this study by ClinicalTrials.gov identifier  NCT00156988

Marianne K Nieuwenhuis, PhD      +31 (0)50 5245560  Ext. 5565    m.k.nieuwenhuis@mzh.nl

Netherlands
      Burns Centre, Martini Hospital, Groningen,  9728NZ,  Netherlands; Recruiting

Study chairs or principal investigators

Marianne K Nieuwenhuis, PhD,  Principal Investigator,  Association Dutch Burns Centres   

Study ID Numbers:  WO/P04.103; WO/P04.103
Last Updated:  September 10, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00156988
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
ClinicalTrials.gov processed this record on 2005-09-13