The Effect of Two Versus Ten Days Application of Flammacerium in Partial Thickness Burns - Full Text View

Sponsor:	Association of Dutch Burn Centres
Collaborator:	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

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

Resource links provided by NLM:

MedlinePlus related topics: Burns Surgery

Drug Information available for: Sulfadiazine Silver sulfadiazine Cerium-flamazine

U.S. FDA Resources

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

Locations

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

Sponsors and Collaborators

Association of Dutch Burn Centres

Dutch Burns Foundation

Investigators

Principal Investigator:

Marianne K Nieuwenhuis, PhD

Association Dutch Burns Centres

More Information

No publications provided

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)

Keywords provided by Association of Dutch Burn Centres:

burns
partial thickness
cerium flamazine
randomised clinical trial

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on November 05, 2009