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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Askina Calgitrol Paste | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Askina Calgitrol Paste | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| The quantification of the amount of silver found in plasma during the treatment | Change from Baseline in Blood at 3 days | |
| The quantification of the amount of silver found in plasma during the treatment | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At each dressing change (an expected average of one day) |
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Inclusion Criteria:
Exclusion Criteria:
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| 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. | 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. | 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. | At each dressing change (an expected average of one day) |
| Adverse Events or Adverse device related event | At each dressing change |