Pressure UlcerNCT05142878
What is the Incidence of Pressure Ulcer Category II-IV (Including Deep-tissue Injury and Unstageable) on a Static Air Foam Hybrid Mattress?
A study testing Ultracore Repose® mattress in people with Pressure Ulcer and Pressure Injury, run by University Ghent at 5 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?
- Ultracore Repose® mattress
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 5 sitesBelgium
- Study dates
- 15 Jul 2020to 1 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
- High risk of pressure ulcers (Braden score < 12) and/or pressure ulcer category 1,
- Bedbound (> 8 hours in bed) or chair bound (> 8 hours in chair),
- Aged > 65 years,
Who cannot join
- Pressure ulcer Category II-IV, deep tissue injury (DTI) or unstageable pressure ulcer,
- Expected length of stay < 2 weeks,
- End of life care,
- Medical contraindication for use of static air support devices
- Caretakers:
- Caretakers will be included in the focus group interviews if they have experience with the use of both the Ultracore Repose® mattress and the Repose overlay mattress®
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Belgium5 sites
Woonzorgcentrum Ter Potterie
Bruges, West-Vlaanderen
Huize Zonnelied
Ieper, West-Vlaanderen
De Plataan
Izegem, West-Vlaanderen
WZC Heilig Hart
Oudenaarde, Osst-Vlaanderen
WZC Egmont
Zottegem, Oost-Vlaanderen
About this study
Official title: Pressure Ulcer Prevention Using Static Air Foam Hybrid Mattress (Ultracore Repose®) in a High Risk Population in Nursing Homes: A Multi-Center Cohort and Qualitative Study
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. They occur frequently among patients with limited mobility, such as those patients being bed-bound and/or wheelchair-bound. In many countries, pressure ulcers are recognized as a national health issue and governments designate pressure ulcers as one of the most important sentinel events for healthcare.
International guidelines recommend the use of pressure redistributing support surfaces, systematic patient repositioning and preventive skin care to prevent pressure ulcers. All interventions should be patient-tailored and based on a thorough assessment of both the patient and contextual risk factors. As pressure ulcers can arise in a number of ways, interventions for prevention and treatment need to be applied across a wide range of settings, including the community, nursing homes and hospitals.
Read more
A review of mortality and severe harm incidents reported to the National Reporting and Learning System found that pressure ulcers were the largest proportion of patient safety incidents in 2011/2012, accounting for 19% of all reports.
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 analysing patient harms across a range of settings, including nursing homes, community nursing and hospitals on a monthly basis.
Continuous low levels or short-term high levels of pressure and shear on the skin and underlying tissue on vulnerable areas are extrinsic factors contributing to the development of pressure ulcers. Support surfaces (e.g. any mattresses, integrated bed systems, mattress replacement, overlay, seat cushion, or seat cushion overlay) are specialized devices for pressure redistribution specifically designed for management of tissue loads, micro- climate, and/or therapeutic functions.
A Cochrane systematic review by McInnes et al. (2015) defined multiple groups of pressure redistribution materials: low-tech (not electrically driven) constant low-pressure supports, high-tech supported surfaces, and other supported surfaces (operating table mattress pad, rotating beds, cushions, and limb protectors). 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 (2016) found a pressure ulcer incidence of 5.1% in patients placed on static air support surfaces (mattress overlay, heel wedge, and seat cushion) in a high risk population in a nursing home setting in Belgium.
A multicentre randomised controlled clinical trial in 26 nursing homes (including 308 residents) between April 2017 and May 2018 resulted in a significantly lower pressure ulcer incidence when applying the principle of static air (n=8/154, 5.2%) compared to the alternating air group (n=18/154, 11.7%)(p=0.04). The median time to develop a pressure ulcer category II-IV was significantly longer in the static air group (10.5 days, IQR 1-14) compared to the alternating air group (5.4 days, IQR 1-12; p=0.05). The study concluded that a static air mattress was significantly more effective compared to an alternating air pressure mattress to prevent pressure ulcers in a high risk nursing home population.
This multicentre cohort study will be performed in 5 nursing homes in a random sample of 40 residents who are at high risk of developing pressure ulcers. Residents will be included in the study for a period of 14 days. Skin assessment and risk factor registration will be done on a daily basis by the nurses. Reliability checks and time measurements will be completed by the researcher.
- Conditions
- Pressure Ulcer, Pressure Injury, Pressure Sore, Bed Sore
- Being tested
- Ultracore Repose® mattress
- Keywords
- static air support devices, High risk population, Elderly, Prevention, Pressure Ulcer
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultracore Repose® mattressDevice
Residents will be placed on the Ultracore Repose® mattress during 14 days
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Static air support devices (Ultracore Repose®) | Experimental | Residents will be placed on a static air foam hybrid mattress during 14 days:
• Ultracore Repose® Mattress Receives: Device: Ultracore Repose® mattress |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure ulcer incidence (Cat. II+)
Incidence rate of pressure ulcers Cat. II-IV (including deep- tissue injury, unstageable), not associated with the use of medical devices
Measured: 14 days
Secondary outcomes (1)
Insight in caretakers' experiences and perceptions
Insight in caretakers' experiences and perceptions (outcome of the focus group interviews) after using Static Air Foam Hybrid Mattress
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 posted3 Dec 2021
- Study start15 Jul 2020
- Primary completion1 Sep 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Frontier Medical Group, UK
- Responsible party
- Sponsor
- Investigators
- Dimitri Beeckman, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05142878
- Sponsor's protocol ID
- EC/2020/BC-06758
- Other IDs
- EC/2020/BC-06758
- Status last verified
- Nov 2021
- First submitted
- 19 Nov 2021
- Last updated
- 29 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pressure Ulcer Prevention Using Static Air Foam Hybrid Mattress (Ultracore Repose®) in a High Risk Population in Nursing Homes: A Multi-Center Cohort and Qualitative Study
- ClinicalTrials.gov ID
- NCT05142878
- Acronym / sponsor ID
- EC/2020/BC-06758
- Conditions
- Pressure Ulcer, Pressure Injury, Pressure Sore, Bed Sore
- Keywords
- static air support devices, High risk population, Elderly, Prevention, Pressure Ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- Frontier Medical Group, UK
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 3 Dec 2021 (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. They occur frequently among patients with limited mobility, such as those patients being bed-bound and/or wheelchair-bound. In many countries, pressure ulcers are recognized as a national health issue and governments designate pressure ulcers as one of the most important sentinel events for healthcare.
International guidelines recommend the use of pressure redistributing support surfaces, systematic patient repositioning and preventive skin care to prevent pressure ulcers. All interventions should be patient-tailored and based on a thorough assessment of both the patient and contextual risk factors. As pressure ulcers can arise in a number of ways, interventions for prevention and treatment need to be applied across a wide range of settings, including the community, nursing homes and hospitals.
A review of mortality and severe harm incidents reported to the National Reporting and Learning System found that pressure ulcers were the largest proportion of patient safety incidents in 2011/2012, accounting for 19% of all reports.
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 analysing patient harms across a range of settings, including nursing homes, community nursing and hospitals on a monthly basis.
Continuous low levels or short-term high levels of pressure and shear on the skin and underlying tissue on vulnerable areas are extrinsic factors contributing to the development of pressure ulcers. Support surfaces (e.g. any mattresses, integrated bed systems, mattress replacement, overlay, seat cushion, or seat cushion overlay) are specialized devices for pressure redistribution specifically designed for management of tissue loads, micro- climate, and/or therapeutic functions.
A Cochrane systematic review by McInnes et al. (2015) defined multiple groups of pressure redistribution materials: low-tech (not electrically driven) constant low-pressure supports, high-tech supported surfaces, and other supported surfaces (operating table mattress pad, rotating beds, cushions, and limb protectors). 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 (2016) found a pressure ulcer incidence of 5.1% in patients placed on static air support surfaces (mattress overlay, heel wedge, and seat cushion) in a high risk population in a nursing home setting in Belgium.
A multicentre randomised controlled clinical trial in 26 nursing homes (including 308 residents) between April 2017 and May 2018 resulted in a significantly lower pressure ulcer incidence when applying the principle of static air (n=8/154, 5.2%) compared to the alternating air group (n=18/154, 11.7%)(p=0.04). The median time to develop a pressure ulcer category II-IV was significantly longer in the static air group (10.5 days, IQR 1-14) compared to the alternating air group (5.4 days, IQR 1-12; p=0.05). The study concluded that a static air mattress was significantly more effective compared to an alternating air pressure mattress to prevent pressure ulcers in a high risk nursing home population.
This multicentre cohort study will be performed in 5 nursing homes in a random sample of 40 residents who are at high risk of developing pressure ulcers. Residents will be included in the study for a period of 14 days. Skin assessment and risk factor registration will be done on a daily basis by the nurses. Reliability checks and time measurements will be completed by the researcher.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Static air support devices (Ultracore Repose®) | Experimental | Device: Ultracore Repose® mattressResidents will be placed on a static air foam hybrid mattress during 14 days: • Ultracore Repose® Mattress |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- High risk of pressure ulcers (Braden score < 12) and/or pressure ulcer category 1,
- Bedbound (> 8 hours in bed) or chair bound (> 8 hours in chair),
- Aged > 65 years,
Key exclusion criteria (6 listed)
- Pressure ulcer Category II-IV, deep tissue injury (DTI) or unstageable pressure ulcer,
- Expected length of stay < 2 weeks,
- End of life care,
- Medical contraindication for use of static air support devices
- Caretakers will be included in the focus group interviews if they have experience with the use of both the Ultracore Repose® mattress and the Repose overlay mattress®
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 |
|---|---|---|
| Ultracore Repose® mattressResidents will be placed on the Ultracore Repose® mattress during 14 days | Device | Experimental: Static air support devices (Ultracore Repose®) |
Primary outcome
Pressure ulcer incidence (Cat. II+)
Time frame: 14 days
Incidence rate of pressure ulcers Cat. II-IV (including deep- tissue injury, unstageable), not associated with the use of medical devices
1 secondary outcome
Insight in caretakers' experiences and perceptions
Time frame: 14 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 29 Dec 2021.
- Description Website of the research groupLink provided by the sponsor.
- Individual participant dataSharing planned: No
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.
Dimitri Beeckman principal investigator
University Ghent
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultracore Repose® mattress in people with Pressure Ulcer and Pressure Injury, run by University Ghent at 5 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 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 29 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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+) (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 29 Dec 2021.