Comparing two types of mattresses to prevent pressure ulcers
Comparing a REactive STatic Air Mattress to an Alternating Air Pressure Mattress in the Prevention of Pressure Ulcers: a Randomized Controlled Trial (RESTART)
This study tests which type of mattress—reactive static air or alternating air pressure—works better to prevent pressure ulcers in patients who are often in bed or sitting for long periods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 308 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vitaz Academic / other |
| Locations | 1 site (Sint-Niklaas, East Flanders) |
| Trial ID | NCT06294327 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness and cost of a reactive static air mattress versus an alternating air pressure mattress in preventing pressure ulcers among patients who are bed or chair-bound. It aims to determine which mattress type is more effective in reducing the incidence of pressure injuries, which are a significant concern in healthcare settings. The study will include patients with a Norton score of less than 14 and will exclude those with more severe pressure ulcers or contraindications to the mattress types being tested.
Who should consider this trial
Good fit: Ideal candidates for this study are patients who are bed or chair-bound with a Norton score of less than 14 and no more than a category I pressure ulcer.
Not a fit: Patients with more severe pressure ulcers (category II, III, IV, or unstageable) or those with a Norton score of 14 or higher will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prevention strategies for pressure ulcers, reducing healthcare costs and enhancing patient quality of life.
How similar studies have performed: Other studies have shown varying success with different mattress types in preventing pressure ulcers, but this specific comparison may provide novel insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Norton score \< 14 * Bed and/or chairfast * no pressure ulcers or at least pressure ulcer category I Exclusion Criteria: * 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
Where this trial is running
Sint-Niklaas, East Flanders
- Vitaz (General Hospital) — Sint-Niklaas, East Flanders, Belgium (Recruiting)
Study contacts
- Study coordinator: Dimitri Beeckman, Prof.
- Email: Dimitri.Beeckman@UGent.be
- Phone: +3237602039
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.