Pressure UlcerNCT03725787
Pressure Ulcer Incidence Cat. II+ on a Static Air Mattress: a Multicenter Cohort Study in Nursing Home Residents at Risk
A study testing CuroCell S.A.M. ® pro mattress in people with Pressure Ulcer and Pressure Injury, run by University Ghent at 8 sites in Belgium.
Trial summary
Pressure Ulcers are a serious and common problem for residents admitted to long-term care facilities and community care patients. They represent a major burden to patients, carers and the Healthcare system, affecting approximately 1 in 20 community patients. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pressure Ulcer, Pressure Injury, Pressure Sore
- What is being tested?
- CuroCell S.A.M. ® pro mattress
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 8 sitesBelgium
- Study dates
- 4 Mar 2018to 6 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- At risk of pressure ulcer development based on a Braden score ≤ 17
- Bedbound or chair bound
- Aged ≥ 65
Who cannot join
- Short-stay residents (expected length of stay ≤14 days)
- End of life care
- Medical contraindication for patient repositioning/turning
- Pressure ulcer Cat. II+ present on initial evaluation
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Belgium8 sites
WZC Sint-Vincentius
Deinze, Oost-Vlaanderen, 9800
WZC Sint-Jozef
Ghent, Oost-Vlaanderen, 9000
WZC Sint-Vincentius
Kaprijke, Oost-Vlaanderen, 9970
WZC Sint-Rafaël
Liedekerke, Vlaams-Brabant, 1770
WZC Brugse Vaart
Mariakerke, Oost-Vlaanderen, 9030
Provinciaal Zorgcentrum Lemberge
Merelbeke, Oost-Vlaanderen, 9820
WZC Onderdale
Ursel, Oost-Vlaanderen, 9910
Residentie Vroonstalle
Wondelgem, Oost-Vlaanderen, 9032
About this study
Official title: Pressure Ulcer Incidence Cat. II+ on the CuroCell SAM® PRO Static Air Mattress: a Multicenter Cohort Study in Nursing Home Residents at Risk
Pressure Ulcers are a serious and common problem for residents admitted to long-term care facilities and community care patients. They represent a major burden to patients, carers and the Healthcare system, affecting approximately 1 in 20 community patients. International guidelines recommend the use of pressure redistribution support surfaces, systematic patient repositioning and preventive skin care to prevent pressure ulcers.
It has been acknowledged that a significant proportion of pressure ulcers are avoidable. The prevalence of pressure ulcers is 1 of the 4 common harms recorded in the UK NHS Safety Thermometer, a local improvement tool for measuring, monitoring and analyzing patient harms across a range of settings, including nursing homes, community nursing and hospitals on a monthly basis.
Read more
Static or reactive overlay mattresses are an example of a low-tech constant low-pressure support. Static air mattresses maintain a continuous low air pressure that exerts a pressure redistributing effect. Serraes and Beeckman found a pressure ulcer incidence of 5.1% in patients placed on static air support (mattress overlay, heel wedge and seat cushion) in a high risk population in a nursing home setting in Belgium.
The CuroCell SAM PRO (Care of Sweden AB) is a static air mattress overlay system used as prevent and treat pressure ulcers (up to category 3) and for pain therapy. The aim of current study is to measure pressure ulcer incidence on the CuroCell Sam PRO static air mattress in nursing home residents at risk for pressure ulcer development over a 30-day period in Belgium.
- Conditions
- Pressure Ulcer, Pressure Injury, Pressure Sore, Bed Sore
- Being tested
- CuroCell S.A.M. ® pro mattress
- Keywords
- Static air support surface, Support device, Elderly, Prevention
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CuroCell S.A.M. ® pro mattressDevice
During 30 days, participants will use the static air mattress.
| Study group | Role | What they receive |
|---|---|---|
| CuroCell S.A.M. ® pro mattress | Experimental | Mattresses of eligible participants will be replaced by a static air pressure redistribution mattress (CuroCell S.A.M. ® Pro). Receives: Device: CuroCell S.A.M. ® pro mattress |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure ulcer incidence (Cat. II+), (NPUAP classification system)
Development of at least 1 pressure ulcer Cat. II+ during study period, not associated with the use of medical devices
Measured: 30 days
Secondary outcomes (2)
Incidence rate of Cat. I pressure ulcers, (NPUAP classification system)
Development of at least 1 pressure ulcer Cat. I during study period, not associated with the use of medical devices
Measured: 30 days
Comfort of participants (self developed questionnaire)
A quantitative approach to obtain insight in residents' experiences and perceptions of comfort by using a questionnaire
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2018
- Study start4 Mar 2018
- Primary completion6 Feb 2019
- Study completion6 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pressure UlcerStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Care of Sweden
- Responsible party
- Sponsor
- Investigators
- Dimitri Beeckman, Phd, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03725787
- Sponsor's protocol ID
- EC/2018/0091
- Other IDs
- B670201835095
- Status last verified
- Oct 2018
- First submitted
- 25 Oct 2018
- Last updated
- 6 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel and Pan Pacific Pressure Injury Alliance. Prevention and Treatment of Pressure Ulcers: Quick Reference Guide. Emily Haesler (Ed.). Cambridge Media: Osborne Park, Western Australia; 201.
Levy A, Kopplin K; BS; Gefen A. Computer simulations of efficacy of air-cell-based cushions in protecting against reoccurrence of pressure ulcers. J Rehabil Res Dev. 2014;51(8):1297-319. doi: 10.1682/JRRD.2014.02.0048.
PubMed 25625315Brown S, Smith IL, Brown JM, Hulme C, McGinnis E, Stubbs N, Nelson EA, Muir D, Rutherford C, Walker K, Henderson V, Wilson L, Gilberts R, Collier H, Fernandez C, Hartley S, Bhogal M, Coleman S, Nixon JE. Pressure RElieving Support SUrfaces: a Randomised Evaluation 2 (PRESSURE 2): study protocol for a randomised controlled trial. Trials. 2016 Dec 20;17(1):604. doi: 10.1186/s13063-016-1703-8.
PubMed 27993145
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pressure Ulcer Incidence Cat. II+ on the CuroCell SAM® PRO Static Air Mattress: a Multicenter Cohort Study in Nursing Home Residents at Risk
- ClinicalTrials.gov ID
- NCT03725787
- Acronym / sponsor ID
- EC/2018/0091
- Conditions
- Pressure Ulcer, Pressure Injury, Pressure Sore, Bed Sore
- Keywords
- Static air support surface, Support device, Elderly, Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- Care of Sweden
- Study start
- 4 Mar 2018 (actual)
- Primary completion
- 6 Feb 2019 (actual)
- Study completion
- 6 Oct 2020 (actual)
- First posted
- 31 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pressure Ulcers are a serious and common problem for residents admitted to long-term care facilities and community care patients. They represent a major burden to patients, carers and the Healthcare system, affecting approximately 1 in 20 community patients. International guidelines recommend the use of pressure redistribution support surfaces, systematic patient repositioning and preventive skin care to prevent pressure ulcers.
It has been acknowledged that a significant proportion of pressure ulcers are avoidable. The prevalence of pressure ulcers is 1 of the 4 common harms recorded in the UK NHS Safety Thermometer, a local improvement tool for measuring, monitoring and analyzing patient harms across a range of settings, including nursing homes, community nursing and hospitals on a monthly basis.
Static or reactive overlay mattresses are an example of a low-tech constant low-pressure support. Static air mattresses maintain a continuous low air pressure that exerts a pressure redistributing effect. Serraes and Beeckman found a pressure ulcer incidence of 5.1% in patients placed on static air support (mattress overlay, heel wedge and seat cushion) in a high risk population in a nursing home setting in Belgium.
The CuroCell SAM PRO (Care of Sweden AB) is a static air mattress overlay system used as prevent and treat pressure ulcers (up to category 3) and for pain therapy. The aim of current study is to measure pressure ulcer incidence on the CuroCell Sam PRO static air mattress in nursing home residents at risk for pressure ulcer development over a 30-day period in Belgium.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CuroCell S.A.M. ® pro mattress | Experimental | Device: CuroCell S.A.M. ® pro mattressMattresses of eligible participants will be replaced by a static air pressure redistribution mattress (CuroCell S.A.M. ® Pro). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- At risk of pressure ulcer development based on a Braden score ≤ 17
- Bedbound or chair bound
- Aged ≥ 65
Key exclusion criteria (4 listed)
- Short-stay residents (expected length of stay ≤14 days)
- End of life care
- Medical contraindication for patient repositioning/turning
- Pressure ulcer Cat. II+ present on initial evaluation
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 |
|---|---|---|
| CuroCell S.A.M. ® pro mattressDuring 30 days, participants will use the static air mattress. | Device | CuroCell S.A.M. ® pro mattress |
Primary outcome
Pressure ulcer incidence (Cat. II+), (NPUAP classification system)
Time frame: 30 days
Development of at least 1 pressure ulcer Cat. II+ during study period, not associated with the use of medical devices
2 secondary outcomes
Incidence rate of Cat. I pressure ulcers, (NPUAP classification system)
Time frame: 30 days
Comfort of participants (self developed questionnaire)
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
- BackgroundNational Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel and Pan Pacific Pressure Injury Alliance. Prevention and Treatment of Pressure Ulcers: Quick Reference Guide. Emily Haesler (Ed.). Cambridge Media: Osborne Park, Western Australia; 201.
- Background: PubMed 25625315Levy A, Kopplin K; BS; Gefen A. Computer simulations of efficacy of air-cell-based cushions in protecting against reoccurrence of pressure ulcers. J Rehabil Res Dev. 2014;51(8):1297-319. doi: 10.1682/JRRD.2014.02.0048.
- Background: PubMed 27993145Brown S, Smith IL, Brown JM, Hulme C, McGinnis E, Stubbs N, Nelson EA, Muir D, Rutherford C, Walker K, Henderson V, Wilson L, Gilberts R, Collier H, Fernandez C, Hartley S, Bhogal M, Coleman S, Nixon JE. Pressure RElieving Support SUrfaces: a Randomised Evaluation 2 (PRESSURE 2): study protocol for a randomised controlled trial. Trials. 2016 Dec 20;17(1):604. doi: 10.1186/s13063-016-1703-8.
- Website of the research groupLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Dimitri Beeckman, Phd principal investigator
Study Principal Investigator
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CuroCell S.A.M. ® pro mattress in people with Pressure Ulcer and Pressure Injury, run by University Ghent at 8 sites in Belgium.
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 3 inclusion and 4 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 6 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Belgium. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pressure ulcer incidence (Cat. II+), (NPUAP classification system) (time frame: 30 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 NCT03725787, which also lists 3 linked publications.
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 6 May 2021.