Pressure UlcerPhase 4NCT01438541
A Multi-centre Evaluation of the Performance of Window Dressings on Subjects With High Risk Pressure Ulceration
A Phase 4 study testing Window in people with Pressure Ulcer, run by Molnlycke Health Care AB at 3 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Ulcer
- What is being tested?
- Window
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Sep 2011to Apr 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- bedfast/chairfast AND completely immobile/very limited mobility
- category 1 PU on any pressure area skin site (see appendix G)
- give their written, informed consent to participate
- expected to be able to comply with follow-up schedule
Who cannot join
- risk area which doesn't fit the dressing size 6*7cm, 10*12 cm and 15*20cm
- subject has category 2-4 pressure ulcer
- subject has documented skin disease at time of enrolment, as judged by the investigator
- known allergy/hypersensitivity to any of the components in the dressing
- previous enroled in the present study
- subject included in other ongoing clinical investigation at present, as judged by the investigator
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
University Hospitals Birmingham NHS
Birmingham, B152TH
Leeds General Infirmary
Leeds, LS1 3EX
The Mid Yourkshire Hospitals NHS Trust
Wakefield, WF1 4DG
About this study
Official title: A Multi-centre, Post CE-mark, Open Study to Evaluate the Performance of Thin Self-adherent Dressing Coated With a Soft Silicone Layer on Subjects With High Risk of Category 2 or Above Pressure Ulceration
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.
- Conditions
- Pressure Ulcer
- Being tested
- Window
- Keywords
- No skin breakdown, Prevention, protection of the skin
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WindowDevice
Dressing
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Window |
What is being measured
The primary outcome is the main question the study is designed to answer.
Erythema ( No/Yes)
Total improvement of erythema
Measured: 14 days
Secondary outcomes (2)
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
Measured: 14 days
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
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionFeb 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pressure UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Molnlycke Health Care AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carol Dealey, BSc, Principal investigator, University Hospital Birmingham NHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01438541
- Sponsor's protocol ID
- Window 02
- Status last verified
- Aug 2016
- First submitted
- 13 Sep 2011
- Last updated
- 14 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre, Post CE-mark, Open Study to Evaluate the Performance of Thin Self-adherent Dressing Coated With a Soft Silicone Layer on Subjects With High Risk of Category 2 or Above Pressure Ulceration
- ClinicalTrials.gov ID
- NCT01438541
- Acronym / sponsor ID
- Window 02
- Conditions
- Pressure Ulcer
- Keywords
- No skin breakdown, Prevention, protection of the skin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Molnlycke Health Care ABIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 22 Sep 2011 (estimated)
- Results
- Posted 14 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Window | Experimental | Device: WindowWindowTM 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- risk area which doesn't fit the dressing size 6*7cm, 10*12 cm and 15*20cm
- subject has category 2-4 pressure ulcer
- subject has documented skin disease at time of enrolment, as judged by the investigator
- known allergy/hypersensitivity to any of the components in the dressing
- previous enroled in the present study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WindowDressing | Device | Window |
Primary outcome
Erythema ( No/Yes)
Time frame: 14 days
Total improvement of erythema
2 secondary outcomes
Overall Experience of Use of the Dressing
Time frame: 14 days
Evaluate the Dressing Shape
Time frame: 14 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carol Dealey, BSc principal investigator
University Hospital Birmingham NHS
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Window in people with Pressure Ulcer, run by Molnlycke Health Care AB at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Erythema ( No/Yes) (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2016.