Status:
WITHDRAWN
Askina Calgitrol Paste Burns
Lead Sponsor:
BBraun Medical SAS
Conditions:
Third Degree Burns
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of the study is to demonstrate that Askina® Calgitrol® Paste is safe to use on III degree burns by quantifying the concentration of silver in the blood during treatment and thus to show th...
Eligibility Criteria
Inclusion
- Adults (≥\>18 years age). No upper age limit
- III degree thermal burns from 2-30% TBSA as determined by the Rule of Nines
- Patients who underwent initial treatment within 24 hours after the injury at the latest
- Patients who underwent initial treatment directly at the Burn Centre of FNKV or the initial treatment was in accordance with the standard of care of the Centre
- All patients will have been hospitalised
- Patients who are capable of giving signing informed consent and have done so.
Exclusion
- Patients with electrical or chemical burns
- Patients with already infected wounds
- Patients taking systemic antibiotics on admission
- Patients pregnant or lactating
- Patients who fall into "vulnerable population" group with respect to informed consent or who are not capable of giving informed consent
- Patients who used or were treated with silver products for other reasons than treatment of the acute burn in the last 3 months
- Patients whose other burn wounds are being treated with silver products.
- Patients receiving renal dialysis
- Known allergy or sensitivity to any of the ingredients in Askina® Calgitrol® Paste.
- Simultaneous participation in another interventional clinical trial
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01911858
Start Date
April 1 2013
Last Update
August 22 2014
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