Burns
Conditions
Keywords
burns, partial thickness, cerium flamazine, randomised clinical trial
Brief summary
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.
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.
Interventions
DRUGcerium nitrate-silver sulfadiazine (cerium-flamazine)
Sponsors
Dutch Burns Foundation
Association of Dutch Burn Centres
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Netherlands
Outcome results
None listed