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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Silicon adhesive dressing | Experimental | Sterile soft silicon adhesive dressing |
|
| Acrylic adhesive dressing | Active Comparator | Sterile acrylic adhesive dressing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Silicon adhesive dressing | Device | Sterile soft silicon adhesive dressing |
| |
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marianne Bergstrom | Sundsvalls Sjukhus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sundsvalls sjukhus | Sundsvall | Sweden | ||||
| Norrlands Universitetssjukhus |
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| ID | Title | Description |
|---|---|---|
| FG000 | AvanceĀ® Film With SafetacĀ® | Sterile soft silicon adhesive dressing Silicon adhesive dressing: Sterile soft silicon adhesive dressing |
| FG001 | AvanceĀ® Transparent Film | Sterile acrylic adhesive dressing Acrylic adhesive dressing: Sterile acrylic adhesive dressing |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The clinical investigation was prematurely closed due to very slow recruitment. Only two subjects were enrolled. Only one went through all visits. No conclusion can be made from the report.
No statistical evaluation was performed because only 2 subjects were included into the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | AvanceĀ® Film With SafetacĀ® | Sterile soft silicon adhesive dressing Silicon adhesive dressing: Sterile soft silicon adhesive dressing |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | No statistical evaluation was performed because only 2 subjects were included into the study and 1 completed follow up (other subject withdrew consent). Due to missing values for the one subject that completed follow up, the primary outcome is presented at 12 days. | Posted | Number | score on a scale | Visit 4 last visit (day 12) |
First Subject In (FSI): 17 Oct 2016 Last Subject Out (LSO): 18 Apr 2017 The subject was followed for 18 days for AE/SAE.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AvanceĀ® Film With SafetacĀ® | Sterile soft silicon adhesive dressing Silicon adhesive dressing: Sterile soft silicon adhesive dressing |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blisters | Skin and subcutaneous tissue disorders | Systematic Assessment | One ADE was reported, blister with a probable relationship to the Investigational Product. |
Early termination of the study due to slow enrollment. Because baseline score was not evaluable for the one subject that completed follow up, primary outcome is presented at 12 days, and not as intended as the change from baseline to last visit.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Research Director | Mƶlnlycke Health Care | +46 31 722 30 00 | info@monlycke.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 11, 2015 | Jan 15, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| Acrylic adhesive dressing |
| Device |
Sterile acrylic adhesive dressing |
|
| UmeƄ |
| Sweden |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Baseline Pain | Pain level was obtained at baseline. 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. | Mean | Standard Deviation | score on a scale |
|
| ID | Title | Description |
|---|---|---|
| OG000 | AvanceĀ® Film With SafetacĀ® | Sterile soft silicon adhesive dressing Silicon adhesive dressing: Sterile soft silicon adhesive dressing |
|
|
| Secondary | 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. | No statistical evaluation was performed because only 2 subjects were included into the study and 1 completed follow up (other subject withdrew consent). All data is presented for the one subject throughout their follow up of 4 visits. | Posted | Number | score on a scale (0-100) | 0-12 days. Visit 1 (baseline), Visit 2 (day 4), Visit 3 (day 7), Visit 4 last visit (day 12) |
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| 0 |
| 2 |
| 0 |
| 2 |
| 1 |
| 2 |
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| Title | Measurements |
|---|---|
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| Visit 2: Pain AFTER removal of the covering film |
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| Visit 2: Pain BEFORE removal of the foam filler |
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| Visit 2: Pain DURING removal of the foam filler |
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| Visit 2: Pain AFTER removal of the foam filler |
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| Visit 3: Pain BEFORE removal of the covering film |
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| Visit 3: Pain DURING removal of the covering film |
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| Visit 3: Pain AFTER removal of the covering film |
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| Visit 3: Pain BEFORE removal of the foam filler |
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| Visit 3: Pain DURING removal of the foam filler |
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| Visit 3: Pain AFTER removal of the foam filler |
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| Visit 4: Pain BEFORE removal of the covering film |
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| Visit 4: Pain DURING removal of the covering film |
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| Visit 4: Pain AFTER removal of the covering film |
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| Visit 4: Pain BEFORE removal of the foam filler |
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| Visit 4: Pain DURING removal of the foam filler |
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| Visit 4: Pain AFTER removal of the foam filler |
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