Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Ischemic
  • Ischemic Ulcer
  • Pressure Ulcer
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: To assess efficacy of a positioning schedule whose frequency of positioning is adapted every day to pressure ulcer risk assessed by Braden scale on the occurrence of pressure ulcer in adult ICUs, in comparison with the routine patients' management (without positioning schedule adapted on PU risk) at the 28th day, or when leaving ICU, or at death if it occurs before.Masking: None (Open Label)Primary Purpose: Prevention

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

This is a multicenter randomized controlled cluster, parallel open study. In order to avoid a contamination bias between groups, this trial will be randomized at the center level. This randomization will lead to the formation of 2 groups: a group of control centers (usual care) and a group of interv...

This is a multicenter randomized controlled cluster, parallel open study. In order to avoid a contamination bias between groups, this trial will be randomized at the center level. This randomization will lead to the formation of 2 groups: a group of control centers (usual care) and a group of interventional centers (repositioning schedule). A visit to set up the study will be carried out before the beginning of the inclusions. During this visit, a training course will be delivered to the caregivers of all the research centers on the risk assessment of pressure ulcers using the Braden scale, the evaluation of the skin condition, the identification of the stages of pressure and their management as well as the collection of data necessary for this study. In addition, the interventional group centers will receive training on the application of the repositioning schedule. The risk assessment for pressure ulcers using the Braden scale will be performed daily in both groups. All patients participating in research with a Braden scale ? 17 will benefit from a pressure ulcer prevention mattress. Usual care: Within the control group, repositioning schedule frequencies and positioning will be done according to the habits of the service. The daily collection form present in the room will collect information concerning the care related to the positioning of the patient (length of treatment, frequency of positioning, type of positioning, any adverse events occurring during this care), the evaluation of the patients 'cutaneous status, duration of pressure ulcer care and evaluation of the Braden scale. The possible contraindications to the positioning of the patients will be informed by the doctors on the medical prescription according to the current practice. Repositioning schedule: Within the interventional group the repositioning schedule will be applied according to the risk of pressure ulcer evaluated daily by the Braden scale. A medical prescription, as part of the care, will attest to the absence of absolute contraindication or relative to the procedure of mobilization. Depending on the result of the Braden scale, the repositioning schedule is defined as follows: 6 ? Braden ? 8: alternate positioning every 2 hours; 9 ?Braden ? 13: alternate positioning every 4 hours; 14 ? Braden ? 17: No alternative of the positioning required, but a friction and an evaluation of the cutaneous state every 6 hours. 18 ?Braden ? 23: No alternative of the positioning required, but a friction and an evaluation of the cutaneous state every 12 hours

Tracking Information

NCT #
NCT04550182
Collaborators
Not Provided
Investigators
Principal Investigator: Daisy Mehay, Degree Nurse in intensive care Assistance Publique - Hôpitaux de Paris