The primary objective of this investigation is to evaluate changes on Peri-Wound skin from baseline to termination when using two different wound dressings The secondary objectives are to evaluate pain before, during, and after dressing removal from baseline to termination
A prospective randomized clinical investigation will be conducted at two sites in Sweden. Male or female, 18 years or older with following wound types: * traumatic, surgical or dehisced wounds, * venous leg ulcer or pressure ulcer will be included into the clinical investigation. 32 evaluated subjects (i:e 16 subjects per arm) will be followed during maximum three weeks. The treatment arm (either silicon adhesive dressing or acrylic adhesive dressing). Patients will be randomized using optimal allocation (minimization) balancing for the following baseline variables type of skin (normal/dry/flaky/oily/moist) and age. Eligible patients will be randomized to receive either silicon adhesive dressing or acrylic adhesive dressing in a ratio of 1:1 provided.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Sterile soft silicon adhesive dressing
Sterile acrylic adhesive dressing
Sundsvalls sjukhus
Sundsvall, Sweden
Norrlands Universitetssjukhus
Umeå, Sweden
Changes on Peri-Wound Skin
The primary objective of this investigation is to evaluate changes on Peri-Wound skin from baseline to termination when using two different wound dressings. The primary endpoint could not be calculated as intended because the baseline score was not evaluable due to missing values for the one subject that completed follow up. The primary outcome is therefore presented at 12 days. The total of the five scores provide a range from 0 to 15, with higher scores indicating a worse outcome. The primary endpoint was assessed through the change in the sum of Peri-Wound Skin outcome scores (0-15) collected at each visit (Visit 1 (baseline), Visit 2 (day 4), Visit 3 (day 7), Visit 4 last visit (day 12)) from baseline to termination. The sum of scores will be obtained from five separate data scores, Redness/Irritation, Flaky, Maceration, Blistering, Skin tears, which will be scored separately with a value between 0 and 3 (None=0, Mild=1, Moderate=2, Severe=3).
Time frame: Visit 4 last visit (day 12)
VAS Scale (0-100mm)
Pain level before, during and after dressing removal. A visual analog scale (VAS) was used by the subjects to assess pain, with a range from 0 to 100, where 100 indicates the worst possible pain.
Time frame: 0-12 days. Visit 1 (baseline), Visit 2 (day 4), Visit 3 (day 7), Visit 4 last visit (day 12)
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