Pressure Ulcer
Conditions
Keywords
No skin breakdown, Prevention, protection of the skin
Brief summary
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.
Interventions
DEVICEWindow
Dressing
Sponsors
Molnlycke Health Care AB
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. acute vascular, surgical, orthopaedic, medical or care of the elderly admission 2. aged 18 years or over 3. have an expected total length of stay of 5 or more days 4. at high risk of PU development due to one or more of the following * bedfast/chairfast AND completely immobile/very limited mobility * category 1 PU on any pressure area skin site (see appendix G) 5. give their written, informed consent to participate 6. expected to be able to comply with follow-up schedule
Exclusion criteria
1. risk area which doesn't fit the dressing size 6\*7cm, 10\*12 cm and 15\*20cm 2. subject has category 2-4 pressure ulcer 3. subject has documented skin disease at time of enrolment, as judged by the investigator 4. known allergy/hypersensitivity to any of the components in the dressing 5. previous enroled in the present study 6. subject included in other ongoing clinical investigation at present, as judged by the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Erythema ( No/Yes) | 14 days | Total improvement of erythema |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Experience of Use of the Dressing | 14 days | 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 |
| Evaluate the Dressing Shape | 14 days | Investigator and Nurses evaluated the shape of the dressing rated on a scale from Very Poor, Poor,Good, Very Good, Excellent |
Countries
United Kingdom
Participant flow
Recruitment details
The recruitment period was from 03 October 2011-21 February 2012. The study was conducted at three wound care units in United Kingdom.
Pre-assignment details
There was no wash-out or run-in phase included in the study.
Participants by arm
| Arm | Count |
|---|---|
| Window WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown. | 29 |
| Total | 29 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | discharge from the hospital | 5 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Window |
|---|---|
| Age, Continuous | 68.6 years STANDARD_DEVIATION 16.9 |
| Region of Enrollment United Kingdom | 29 participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 29 |
| serious Total, serious adverse events | 0 / 29 |
Outcome results
Primary
Erythema ( No/Yes)
Total improvement of erythema
Time frame: 14 days
Population: Vulnerable subjects with high risk of skin breakdown.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Window | Erythema ( No/Yes) | Erytehma Baseline No | 5 participants |
| Window | Erythema ( No/Yes) | Erytema Baseline Yes | 24 participants |
| Window | Erythema ( No/Yes) | Erythema Last visit No | 16 participants |
| Window | Erythema ( No/Yes) | Erytehma Last visit Yes | 13 participants |
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
Time frame: 14 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Window | Evaluate the Dressing Shape | Very Poor | 0 participants |
| Window | Evaluate the Dressing Shape | Poor | 4 participants |
| Window | Evaluate the Dressing Shape | Good | 22 participants |
| Window | Evaluate the Dressing Shape | Very Good | 1 participants |
| Window | Evaluate the Dressing Shape | Excellent | 2 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
Time frame: 14 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Window | Overall Experience of Use of the Dressing | Excellent | 1 participants |
| Window | Overall Experience of Use of the Dressing | Very Poor | 1 participants |
| Window | Overall Experience of Use of the Dressing | Poor | 10 participants |
| Window | Overall Experience of Use of the Dressing | Good | 15 participants |
| Window | Overall Experience of Use of the Dressing | Very Good | 0 participants |
| Window | Overall Experience of Use of the Dressing | Not measured | 2 participants |