CompletedPhase 4

A Multi-centre Evaluation of the Performance of Window Dressings on Subjects With High Risk Pressure Ulceration

United Kingdom29 participantsStarted 2011-09

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

. risk area which doesn't fit the dressing size 6\*7cm, 10\*12 cm and 15\*20cm

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Erythema ( No/Yes)

Timeframe: 14 days

Trial details

NCT IDNCT01438541

SponsorMolnlycke Health Care AB

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-02

Results submitted2016-05-13

View on ClinicalTrials.gov More Pressure Ulcer trials