Pressure InjuryNCT06294327
RESTART the Prevention of Pressure Ulcers: Comparing the Effectiveness and Cost of a Reactive Static Air Mattress and Alternating Air Pressure Mattress
A study testing Reactive static air support surfaces in people with Pressure Injury and Pressure Ulcer, run by Vitaz at 1 site in Belgium.
Trial summary
Pressure ulcers are a global issue and substantial concern for healthcare systems. A review of the literature between January 2000 and December 2012 has revealed that prevalence rate of pressure ulcers in aged care facilities were between 4.1% and 32.2%, and the incidence rates ranged from 1.9% to 59%. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pressure Injury, Pressure Ulcer, Decubitus Ulcer
- What is being tested?
- Reactive static air support surfaces
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 621 participants
- Where
- 1 siteBelgium
- Study dates
- 22 Jan 2024to 24 Jul 2026
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Norton score < 14
- Bed and/or chairfast
- no pressure ulcers or at least pressure ulcer category I
Who cannot join
- Norton Score >/=14
- Pressure ulcers category II, III, IV, deep tissue injury (DTI) or unstageable pressure ulcer
- Expected length of hospital stay < 2 days
- Medical contraindication for use of reactive static air support surfaces
- End of life care (or Do Not Reanimate (DNR) code IV)
- Age < 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing a REactive STatic Air Mattress to an Alternating Air Pressure Mattress in the Prevention of Pressure Ulcers: a Randomized Controlled Trial (RESTART)
Pressure ulcers are a global issue and substantial concern for healthcare systems. A review of the literature between January 2000 and December 2012 has revealed that prevalence rate of pressure ulcers in aged care facilities were between 4.1% and 32.2%, and the incidence rates ranged from 1.9% to 59%. Similarly, a systematic review reported that the prevalence of pressure ulcer varied between 0.3% and 46%, and the incidence of pressure ulcer ranged from 0.8% to 34%. Most epidemiological data were obtained from hospitals (38.7%) and institutional long-term care facilities (29.7%).
The costs associated with pressure ulcers are considerable. According to the Agency for Healthcare Research \& Quality (2011), the US healthcare system has allocated approximately $ 9.1 - $ 11.6 billion annually for the health care cost of pressure ulcer. In addition to direct treatment-related costs, the development of pressure ulcer also results in litigation and government penalties, and affects hospital performance metrics. A systematic review has reported that the cost for treatment of pressure ulcer was higher than its prevention. That is, the cost per patient per day ranged from € 1.71 to € 470.49 (for treatment) and from € 2.65 to € 87.57 (for prevention) across all settings.
This randomized controlled trial will be performed in a general hospital in a random sample of 308 patients (nursing wards geriatric n=3 and orthopedic (n=3)) who are at high risk of developing pressure ulcers. Patients will be included in the study for a period > 2 hospitalisation days. Skin assessment and risk factor registration will be done on a daily base by the ward nurses. Reliability checks and time measurements will be completed by the researcher.
- Conditions
- Pressure Injury, Pressure Ulcer, Decubitus Ulcer
- Being tested
- Reactive static air support surfaces
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reactive static air support surfacesDevice
Also called Repose® devices
- Repose® Mattress
- Repose® Cushion
- Repose® Wedge
- Repose® Foot Protectors
| Study group | Role | What they receive |
|---|---|---|
| Reactive static air support surfaces (Repose®) | Experimental | Intervention with Repose® devices
Standard repositioning protocol is applied. Receives: Device: Reactive static air support surfaces |
| Alternating air pressure mattress (ArjoHuntleigh® Alpha Response) | No intervention | Standard care with mattress type: ArjoHuntleigh® Alpha Response Standard repositioning protocol is applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of pressure ulcer, category > I
Development of a pressure ulcer category > I
Measured: After admission
Secondary outcomes (2)
Cost of alternating air pressure mattress compared to reactive static air support surfaces
Economic cost (€)
Measured: After admission
Patient comfort
To measure the degree of comfort a five point Likert scale was used (1 - 'not comfortable at all', 2 - 'not very comfortable', 3 - 'more or less comfortable', 4 - 'very comfortable', and 5 - 'totally comfortable')
Measured: After admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start22 Jan 2024
- Primary completion30 Jun 2025
- Study completion24 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pressure InjuryStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 621 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vitaz
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06294327
- Sponsor's protocol ID
- EC23027
- Status last verified
- Jul 2026
- First submitted
- 27 Feb 2024
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Anrys C, Van Tiggelen H, Verhaeghe S, Van Hecke A, Beeckman D. Independent risk factors for pressure ulcer development in a high-risk nursing home population receiving evidence-based pressure ulcer prevention: Results from a study in 26 nursing homes in Belgium. Int Wound J. 2019 Apr;16(2):325-333. doi: 10.1111/iwj.13032. Epub 2018 Nov 9.
PubMed 30412652Shi C, Dumville JC, Cullum N, Rhodes S, Leung V, McInnes E. Reactive air surfaces for preventing pressure ulcers. Cochrane Database Syst Rev. 2021 May 7;5(5):CD013622. doi: 10.1002/14651858.CD013622.pub2.
PubMed 33999463Beeckman D, Serraes B, Anrys C, Van Tiggelen H, Van Hecke A, Verhaeghe S. A multicentre prospective randomised controlled clinical trial comparing the effectiveness and cost of a static air mattress and alternating air pressure mattress to prevent pressure ulcers in nursing home residents. Int J Nurs Stud. 2019 Sep;97:105-113. doi: 10.1016/j.ijnurstu.2019.05.015. Epub 2019 Jun 8.
PubMed 31234104Serraes B, van Leen M, Schols J, Van Hecke A, Verhaeghe S, Beeckman D. Prevention of pressure ulcers with a static air support surface: A systematic review. Int Wound J. 2018 Jun;15(3):333-343. doi: 10.1111/iwj.12870. Epub 2018 Mar 5.
PubMed 29504266
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing a REactive STatic Air Mattress to an Alternating Air Pressure Mattress in the Prevention of Pressure Ulcers: a Randomized Controlled Trial (RESTART)
- ClinicalTrials.gov ID
- NCT06294327
- Acronym / sponsor ID
- EC23027
- Conditions
- Pressure Injury, Pressure Ulcer, Decubitus Ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 621 participants (actual)
- Lead sponsor
- VitazUniversity, hospital or other
- Collaborators
- University Ghent
- Study start
- 22 Jan 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 24 Jul 2026 (actual)
- First posted
- 5 Mar 2024 (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 global issue and substantial concern for healthcare systems. A review of the literature between January 2000 and December 2012 has revealed that prevalence rate of pressure ulcers in aged care facilities were between 4.1% and 32.2%, and the incidence rates ranged from 1.9% to 59%. Similarly, a systematic review reported that the prevalence of pressure ulcer varied between 0.3% and 46%, and the incidence of pressure ulcer ranged from 0.8% to 34%. Most epidemiological data were obtained from hospitals (38.7%) and institutional long-term care facilities (29.7%).
The costs associated with pressure ulcers are considerable. According to the Agency for Healthcare Research \& Quality (2011), the US healthcare system has allocated approximately $ 9.1 - $ 11.6 billion annually for the health care cost of pressure ulcer. In addition to direct treatment-related costs, the development of pressure ulcer also results in litigation and government penalties, and affects hospital performance metrics. A systematic review has reported that the cost for treatment of pressure ulcer was higher than its prevention. That is, the cost per patient per day ranged from € 1.71 to € 470.49 (for treatment) and from € 2.65 to € 87.57 (for prevention) across all settings.
This randomized controlled trial will be performed in a general hospital in a random sample of 308 patients (nursing wards geriatric n=3 and orthopedic (n=3)) who are at high risk of developing pressure ulcers. Patients will be included in the study for a period > 2 hospitalisation days. Skin assessment and risk factor registration will be done on a daily base by the ward nurses. Reliability checks and time measurements will be completed by the researcher.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reactive static air support surfaces (Repose®) | Experimental | Device: Reactive static air support surfacesIntervention with Repose® devices Standard repositioning protocol is applied. |
| Alternating air pressure mattress (ArjoHuntleigh® Alpha Response) | No intervention | –Standard care with mattress type: ArjoHuntleigh® Alpha Response Standard repositioning protocol is applied. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Norton score < 14
- Bed and/or chairfast
- no pressure ulcers or at least pressure ulcer category I
Key exclusion criteria (6 listed)
- Norton Score >/=14
- Pressure ulcers category II, III, IV, deep tissue injury (DTI) or unstageable pressure ulcer
- Expected length of hospital stay < 2 days
- Medical contraindication for use of reactive static air support surfaces
- End of life care (or Do Not Reanimate (DNR) code IV)
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 |
|---|---|---|
| Reactive static air support surfacesAlso: Repose® devices* Repose® Mattress * Repose® Cushion * Repose® Wedge * Repose® Foot Protectors | Device | Reactive static air support surfaces (Repose®) |
Primary outcome
Incidence of pressure ulcer, category > I
Time frame: After admission
Development of a pressure ulcer category > I
2 secondary outcomes
Cost of alternating air pressure mattress compared to reactive static air support surfaces
Time frame: After admission
Patient comfort
Time frame: After admission
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 27 Jul 2026.
- Background: PubMed 30412652Anrys C, Van Tiggelen H, Verhaeghe S, Van Hecke A, Beeckman D. Independent risk factors for pressure ulcer development in a high-risk nursing home population receiving evidence-based pressure ulcer prevention: Results from a study in 26 nursing homes in Belgium. Int Wound J. 2019 Apr;16(2):325-333. doi: 10.1111/iwj.13032. Epub 2018 Nov 9.
- Background: PubMed 33999463Shi C, Dumville JC, Cullum N, Rhodes S, Leung V, McInnes E. Reactive air surfaces for preventing pressure ulcers. Cochrane Database Syst Rev. 2021 May 7;5(5):CD013622. doi: 10.1002/14651858.CD013622.pub2.
- Background: PubMed 31234104Beeckman D, Serraes B, Anrys C, Van Tiggelen H, Van Hecke A, Verhaeghe S. A multicentre prospective randomised controlled clinical trial comparing the effectiveness and cost of a static air mattress and alternating air pressure mattress to prevent pressure ulcers in nursing home residents. Int J Nurs Stud. 2019 Sep;97:105-113. doi: 10.1016/j.ijnurstu.2019.05.015. Epub 2019 Jun 8.
- Background: PubMed 29504266Serraes B, van Leen M, Schols J, Van Hecke A, Verhaeghe S, Beeckman D. Prevention of pressure ulcers with a static air support surface: A systematic review. Int Wound J. 2018 Jun;15(3):333-343. doi: 10.1111/iwj.12870. Epub 2018 Mar 5.
- SKIN INTEGRITY RESEARCH GROUP (SKINT)Link provided by the sponsor.
- UniversityLink provided by the sponsor.
- Study location; VITAZ (general) Hospital and Health Care VITAZ, Moerlandstraat 1, B-9100 Sint-Niklaas BelgiumLink 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reactive static air support surfaces in people with Pressure Injury and Pressure Ulcer, run by Vitaz at 1 site 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 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Incidence of pressure ulcer, category > I (time frame: After admission). 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 NCT06294327, which also lists 4 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 27 Jul 2026.