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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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

Other trials in United Kingdom

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

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 groups in NCT01438541
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.

Sep 2011Apr 2012

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Efficacy and Safety of ZKARE® Gel and Its Accessory ZKAPI® in the Treatment of Chronic Ulcers.
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The Effectiveness of a Caregiver-Based Multicomponent Intervention to Prevent Pressure Ulcers in Home-Cared-For Individuals With Dementia
Dementia, Home Care for Elderly or Disabled Individuals
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Hypertrophic Scar Prosthetic Pressure in Burn Amputee
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All Pressure Ulcer trials

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.

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

Results posted to the registry on 14 Oct 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Window	29	22

Primary outcome: Erythema ( No/Yes)

Time frame: 14 days. Number. Unit: participants

Measure	Window n = 29
Erytehma Baseline No	5
Erytema Baseline Yes	24
Erythema Last visit No	16
Erytehma Last visit Yes	13

Population analysed: Vulnerable subjects with high risk of skin breakdown.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events were collected from baseline to termination (14days). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Window	0 of 29 (0%)	2 of 29 (6.9%)	Not reported

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.

Related trials for Pressure Ulcer

Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Not yet recruiting
Pulsed High Intensity Laser Versus Negative Pressure Therapy On Neuropathic Ulcers
Neuropathic Ulcers
Recruiting
Efficacy and Safety of ZKARE® Gel and Its Accessory ZKAPI® in the Treatment of Chronic Ulcers.
Chronic Ulcers
Not yet recruiting
The Effectiveness of a Caregiver-Based Multicomponent Intervention to Prevent Pressure Ulcers in Home-Cared-For Individuals With Dementia
Dementia, Home Care for Elderly or Disabled Individuals
Not yet recruitingObservational study
Hypertrophic Scar Prosthetic Pressure in Burn Amputee
Amputation Stump, Burn Injury

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?

On the ClinicalTrials.gov record for NCT01438541.

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.