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Search / Trial NCT06294327

RESTART the Prevention of Pressure Ulcers: Comparing the Effectiveness and Cost of a Reactive Static Air Mattress and Alternating Air Pressure Mattress

Launched by VITAZ · Feb 27, 2024

Trial Information

Current as of July 22, 2025

Recruiting

Keywords

ClinConnect Summary

The RESTART clinical trial is studying two types of mattresses to see which one is better at preventing pressure ulcers, also known as bedsores. Pressure ulcers are painful wounds that can develop when someone is in the same position for a long time, especially in older adults or those with limited mobility. The trial will involve about 308 patients in a general hospital, particularly in nursing and orthopedic wards, who are at high risk for developing these sores. To participate, patients need to be at least 65 years old, unable to get out of bed or a chair easily, and have either no pressure ulcers or only the very early stage of one.

During the trial, nurses will check participants' skin every day and record any risk factors that could lead to pressure ulcers. The goal is to find out which mattress—either a reactive static air mattress or an alternating air pressure mattress—can best help prevent these injuries. It's important to note that participants should expect to be in the study for at least two days during their hospital stay, and the care team will be closely monitoring their condition throughout the trial.

Gender

ALL

Eligibility 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

About Vitaz

Vitaz is a leading clinical trial sponsor dedicated to advancing healthcare through innovative research and development. With a focus on enhancing patient outcomes, Vitaz collaborates with healthcare professionals and institutions to conduct rigorous clinical trials across diverse therapeutic areas. Committed to upholding the highest standards of ethics and scientific integrity, Vitaz leverages cutting-edge technology and a patient-centric approach to streamline trial processes and ensure robust data collection. Through its dedication to innovation and excellence, Vitaz aims to contribute significantly to the development of new therapies and improve the quality of life for patients worldwide.

Locations

Sint Niklaas, East Flanders, Belgium

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported