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The Effect of Two Versus Ten Days Application of Flammacerium in Partial Thickness Burns
This study is currently recruiting participants.
Verified by Association of Dutch Burn Centres, September 2005
Sponsors and Collaborators: Association of Dutch Burn Centres
Dutch Burns Foundation
Information provided by: Association of Dutch Burn Centres
ClinicalTrials.gov Identifier: NCT00156988
  Purpose

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

MedlinePlus related topics: Burns
Drug Information available for: Sulfadiazine Silver sulfadiazine Cerium-flamazine
U.S. FDA Resources
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

Further study details as provided by Association of Dutch Burn Centres:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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

Study Start Date: March 2004
Estimated Study Completion Date: December 2005
Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00156988

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

Locations
Netherlands
Burns Centre, Martini Hospital Recruiting
Groningen, Netherlands, 9728NZ
Contact: Marianne K Nieuwenhuis, PhD     +31 (0)50 5245560 ext 5565     m.k.nieuwenhuis@mzh.nl    
Principal Investigator: Marianne K Nieuwenhuis, PhD            
Sponsors and Collaborators
Association of Dutch Burn Centres
Dutch Burns Foundation
Investigators
Principal Investigator: Marianne K Nieuwenhuis, PhD Association Dutch Burns Centres
  More Information

Study ID Numbers: WO/P04.103, WO/P04.103
Study First Received: September 8, 2005
Last Updated: September 8, 2005
ClinicalTrials.gov Identifier: NCT00156988  
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Association of Dutch Burn Centres:
burns
partial thickness
cerium flamazine
randomised clinical trial

Study placed in the following topic categories:
Burns
Silver Sulfadiazine
Wounds and Injuries
Disorders of Environmental Origin
Sulfadiazine
Cerium nitrate

Additional relevant MeSH terms:
Anti-Infective Agents
Anti-Infective Agents, Local
Antiparasitic Agents
Antiprotozoal Agents
Therapeutic Uses
Coccidiostats
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009