The Effect of Two Versus Ten Days Application of Flammacerium in Partial Thickness Burns
Information source: Association of Dutch Burn Centres
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Burns
Intervention: cerium nitrate-silver sulfadiazine (cerium-flamazine) (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Association of Dutch Burn Centres Official(s) and/or principal investigator(s):
Marianne K Nieuwenhuis, PhD, Principal Investigator, Affiliation: Association Dutch Burns Centres
Overall contact:
Marianne K Nieuwenhuis, PhD, Phone: +31 (0)50 5245560, Ext: 5565, Email: m.k.nieuwenhuis@mzh.nl
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.
Clinical Details
Official title: The Effect of Two Versus Ten Days Application of Flammacerium in Partial Thickness Burns
Study design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: 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: 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
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
Minimum age: N/A.
Maximum age: N/A.
Gender(s): 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
Locations and Contacts
Marianne K Nieuwenhuis, PhD, Phone: +31 (0)50 5245560, Ext: 5565, Email: m.k.nieuwenhuis@mzh.nl
Burns Centre, Martini Hospital, Groningen 9728NZ, Netherlands; Recruiting
Marianne K Nieuwenhuis, PhD, Phone: +31 (0)50 5245560, Ext: 5565, Email: m.k.nieuwenhuis@mzh.nl
Marianne K Nieuwenhuis, PhD, Principal Investigator
Additional Information
Starting date: March 2004
Ending date: December 2005
Last updated: September 8, 2005
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