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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Burns

Intervention / Treatment
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* Drug: cerium nitrate-silver sulfadiazine (cerium-flamazine)


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: cerium nitrate-silver sulfadiazine (cerium-flamazine)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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burns, partial thickness, cerium flamazine, randomised clinical trial