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 that the amount of silver absorbed will be no greater than those reported in the literature.
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
The quantification of the amount of silver found in plasma during the treatment
Time frame: Change from Baseline in Blood at 3 days
The quantification of the amount of silver found in plasma during the treatment
Time frame: Change from Baseline in Blood immediately after the removal of the last investigational dressing (the day before necrotomy, an expected average between 3-10 days after inclusion)
Wound bed and periwound skin conditions
Data will not be recorded at specific time points due to individual changing patterns. The investigator will make a subjective description of the wound bed covered by necrosis, slough/fibrin, granulation tissue and epithelialisation and by the condition of the peri-wound skin.
Time frame: At each dressing change (an expected average of one day)
Clinical signs of infection
Data will not be recorded at specific time points due to individual changing patterns. The presence and intensity of clinical signs of infection will be assessed at the start of the study and at each dressing change using clinical judgment and a scoring system modified from the one published by Trial and al.
Time frame: At each dressing change (an expected average of one day)
Patient comfort
Data will not be recorded at specific time points due to individual changing patterns. The investigator will complete a Likert scale score (1-4, Poor, Fair, Good, Excellent) for each ease of application and ease of removal of Askina Calgitrol Paste at each dressing change.
Time frame: At each dressing change (an expected average of one day)
Number of dressing changes
Data will not be recorded at specific time points due to individual changing patterns.
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Time frame: At each dressing change (an expected average of one day)
Adverse Events or Adverse device related event
Time frame: At each dressing change