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This study will be conducted in approximately 26 subjects in UK to yield 20 evaluable subjects at 3 sites with approximately 5-10 subjects/site. Subjects with acute vascular, surgical and orthopaedic medical care in the elderly admission, with a high risk to develop skin breakdown or subjects with category 1 pressure ulcer can be enrolled in this investigation.
The rational for this study is to evaluate the potential for Window in the prevention of pressure ulcers because of its ability to reduce shear and friction forces.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Window | Experimental | WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown. Window TM provides instant tack adhesion that minimizes the requirement of extra pressure in order to fixate well. The product does not leave residues and the adhesion level does not increase over time. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Window | Device | Dressing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Erythema ( No/Yes) | Total improvement of erythema | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Experience of Use of the Dressing | Investigator and Nurses evaluate the overall Experience of using of the dressing rated on a scale from Very Poor, Poor,Good, Very Good, Excellent, Not measured | 14 days |
| Evaluate the Dressing Shape |
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Inclusion Criteria:
acute vascular, surgical, orthopaedic, medical or care of the elderly admission
aged 18 years or over
have an expected total length of stay of 5 or more days
at high risk of PU development due to one or more of the following
give their written, informed consent to participate
expected to be able to comply with follow-up schedule
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carol Dealey, BSc | University Hospital Birmingham NHS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Birmingham NHS | Birmingham | B152TH | United Kingdom | |||
| Leeds General Infirmary |
There was no wash-out or run-in phase included in the study.
The recruitment period was from 03 October 2011-21 February 2012. The study was conducted at three wound care units in United Kingdom.
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| ID | Title | Description |
|---|---|---|
| FG000 | Window | WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Window | WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Erythema ( No/Yes) | Total improvement of erythema | Vulnerable subjects with high risk of skin breakdown. | Posted | Number | participants | 14 days |
|
|
Adverse Events were collected from baseline to termination (14days)
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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 | Window | WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ruptured blister - broken skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tina Kjellén | Molnlycke Health Care AB | +46317223098 | tina.kjellen@molnlycke.com |
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| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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Investigator and Nurses evaluated the shape of the dressing rated on a scale from Very Poor, Poor,Good, Very Good, Excellent
| 14 days |
| Leeds |
| LS1 3EX |
| United Kingdom |
| The Mid Yourkshire Hospitals NHS Trust | Wakefield | WF1 4DG | United Kingdom |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Overall Experience of Use of the Dressing | Investigator and Nurses evaluate the overall Experience of using of the dressing rated on a scale from Very Poor, Poor,Good, Very Good, Excellent, Not measured | Posted | Number | participants | 14 days |
|
|
|
| Secondary | Evaluate the Dressing Shape | Investigator and Nurses evaluated the shape of the dressing rated on a scale from Very Poor, Poor,Good, Very Good, Excellent | Posted | Number | participants | 14 days |
|
|
|
| 0 |
| 29 |
| 2 |
| 29 |
| Recurrence of ruptured blister in different | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Grade 2 area to L buttock 2mm x 2 mm | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| Very Good |
|
| Excellent |
|
| Not measured |
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| Very Good |
|
| Excellent |
|