The Effect of Two Versus Ten Days Application of Flammacerium in Partial Thickness Burns

A

Association of Dutch Burn Centres

Status and phase

Completed
Phase 4

Conditions

Burns

Treatments

Drug: cerium nitrate-silver sulfadiazine (cerium-flamazine)

Study type

Interventional

Funder types

Other

Identifiers

NCT00156988
WO/P04.103

Details and patient eligibility

About

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.

Full 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.

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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