Ignite Creation Date:
2024-05-06 @ 3:21 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04604665
Status:
COMPLETED
Last Update Posted:
2024-01-22
First Post:
2020-10-14
Brief Title:
Evaluation of Two Levels of Frequency of Repositioning in the Reduction of Pressure Ulcers
Sponsor:
Fundación Cardioinfantil Instituto de Cardiología
Organization:
Fundación Cardioinfantil Instituto de Cardiología
Study Overview
Official Title:
Evaluation of the Efficacy of Two Levels of Frequency of Repositioning in Adults Hospitalized in Intensive Care Units in the Reduction of Pressure Ulcers A Randomized Cluster Study
Status:
COMPLETED
Status Verified Date:
2024-01
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:
PENFUP-2
Brief Summary:
PENFUP FASE 2 It is a multicenter study by parallel conglomerates planned in order to evaluate the efficacy between two levels of frequency of postural change in intensive care units for adults of hospitals in various regions of Colombia
Detailed Description:
Taking into account a design effect of 67 Investigators planned to include 150 participants from each ICU Investigators did calculate that a total of 22 ICUs are required in which 11 will be assigned to the low frequency and 11 will be assigned to a high frequency group of postural change until obtaining a total of 1650 patients in each arm of the study and a total of 3300 participants in the study
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