Clinical Investigation of Two Different Wound Dressings

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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A Randomized Open, Controlled Pilot Investigation Comparing Trauma to the Periwound Skin and Pain During Treatment With Avance NPWT System When Using Two Different Fixations

Conditions
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Wounds and Injuries

Intervention / Treatment
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* Device: Silicon adhesive dressing
* Device: Acrylic adhesive dressing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Traumatic, surgical or dehisced wounds, Venous Leg Ulcer, Diabetic Foot Ulcer or Pressure Ulcer indicated for treatment with NPWT therapy In case of multiple wounds the target wound must be ≥10 cm distant from other wounds. Selection of the target wound is according to the investigator's preference. Peri-wound skin assessable and 5 cm of peri-wound skin present around the wound Male or female, 18 years of age and above Signed Informed Consent Exclusion Criteria: Dressing sizes does not fit the target wound Unexplored blind tunnels or non-enteric fistula Untreated osteomyelitis Malignant wounds Subjects treated with systemic immunosuppressive or glucocorticosteroids, except subjects taking occasional doses or doses less than 10mg prednisolon/day or equivalent. Wounds with necrotic tissue or eschar (if not adequately debrided) Significantly bleeding wounds, as judged by the investigator Subject not suitable for the investigation according to the investigator's judgment Subject included in other ongoing clinical investigation which could interfere with this investigation, as judged by the investigator Known allergy/hypersensitivity to any of the components included into the investigation.

Ages Eligible for Study
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Minimum Age: 18 Years

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Silicon adhesive dressing<br>Sterile soft silicon adhesive dressing | Device: Silicon adhesive dressing<br>* Sterile soft silicon adhesive dressing<br>|
| Active Comparator: Acrylic adhesive dressing<br>Sterile acrylic adhesive dressing | Device: Acrylic adhesive dressing<br>* Sterile acrylic adhesive dressing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Visit 4 last visit (day 12) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 0-12 days. Visit 1 (baseline), Visit 2 (day 4), Visit 3 (day 7), Visit 4 last visit (day 12) |