NCT06294327 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

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.
Beeckman 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.
Serraes 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.
Shi 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.

Comparing a REactive STatic Air Mattress to an Alternating Air Pressure Mattress in the Prevention of Pressure Ulcers: a Randomized Controlled Trial (RESTART)

Details for clinical trial NCT06294327

Clinical trial NCT06294327 - References