Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06294327
Status:
RECRUITING
Last Update Posted:
2024-03-07
First Post:
2024-02-27
Brief Title:
RESTART the Prevention of Pressure Ulcers Comparing the Effectiveness and Cost of a Reactive Static Air Mattress and Alternating Air Pressure Mattress
Sponsor:
Vitaz
Organization:
Vitaz
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 41 and 322 and the incidence rates ranged from 19 to 59 Similarly a systematic review reported that the prevalence of pressure ulcer varied between 03 and 46 and the incidence of pressure ulcer ranged from 08 to 34 Most epidemiological data were obtained from hospitals 387 and institutional long-term care facilities 297
The costs associated with pressure ulcers are considerable According to the Agency for Healthcare Research Quality 2011 the US healthcare system has allocated approximately 91 - 116 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 171 to 47049 for treatment and from 265 to 8757 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 n3 and orthopedic n3 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
The costs associated with pressure ulcers are considerable According to the Agency for Healthcare Research Quality 2011 the US healthcare system has allocated approximately 91 - 116 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 171 to 47049 for treatment and from 265 to 8757 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 n3 and orthopedic n3 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None