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The aim of this clinical trial is to determine whether 5-layer hydrocellular dressings are effective in preventing the development of pressure sores during prone positioning in the intensive care unit. The main questions it aims to answer are:
- are hydrocellular dressings the best strategy for preventing pressure sores? is this strategy simpler and less costly? The researchers will compare hydrocellular dressings with hydrocolloid dressings to find out whether they are more effective in preventing the development of pressure sores in the prone position.
Participants will be given either hydrocellular or hydrocolloid dressings, and caregivers will assess whether or not pressure sores develop after prone positioning.
Hydrocellular dressings will be compared with hydrocolloid dressings to determine their effectiveness in preventing pressure ulcers during ventral decubitus in intensive care. The dressings will cover the skin in at-risk areas, and caregivers will assess whether or not pressure sores develop in these areas after prone positioning. The stage of these pressure sores will also be assessed.
The time spent on each strategy and the cost per strategy will also be evaluated. Dressings will be applied for the entire period during which participants are placed in the prone position. If they develop pressure sores during this period, they will be followed up until their discharge from intensive care to study the evolution of these pressure sores.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydrocellular | Experimental | Application of hydrocellular dressings prior to prone positioning and standard pressure sore prevention strategy. Dressings can remain in place for up to 7 days. |
|
| Hydrocolloid | Active Comparator | Application of hydrocolloids dressings prior to prone positioning and standard pressure sore prevention strategy. Dressings are removed after each prone position. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrocellular dressing | Other | Application of hydrocellular dressings to at-risk areas prior to prone positioning. Assessment of pressure sores and their stage after prone positioning. |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the time to onset of one or more pressure ulcers during Ventral Decubitus(VD) sessions in the ICU with the type of preventive dressing selected (thick hydrocolloid or 5-layer hydrocellular) | Time to occurrence of a grade 2 or higher pressure ulcer in the intensive care unit in VD, according to the National Pressure Ulcer Advisory Panel (NPUAP) classification | 30 minutes after being put back on its back |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the location of pressure sores between the two groups | Number of pressure sores (stages 1 to 4) on predetermined risk areas protected by both types of dressing (periorbital, malar, mandible/chin, thorax, shoulders, iliac crests, knees, other). | 30 minutes after putting the participant back on his back |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Agathe Hamelin | Contact | 02.31.06.47.11 | hamelin-a@chu-caen.fr | |
| Clémence Tomadesso | Contact | 02 31 06 53 86 | tomadesso-c@chu-caen.fr |
| Name | Affiliation | Role |
|---|---|---|
| Agathe Hamelin | University Hospital, Caen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU | Recruiting | Caen | 14000 | France |
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| Hydrocolloids dressing | Other | Application of hydrocolloids dressings to at-risk areas prior to prone positioning. |
|
| Compare the severity of pressure sores between the two groups |
Severity of pressure sore according to NPUAP classification (stages 1 to 4) |
| 30 minutes after putting the participant back on his back |
| Compare the evolution of pressure sores between the two groups up to discharge from the intensive care unit. | Evolution of the pressure sore according to NPUAP classification. During the VD period, assessment is carried out daily after repositioning in Dorsal Decubitus (DD). After the end of the DV, any dressings applied to treat a pressure sore will no longer be the randomized dressings, but the most suitable dressings according to the predefined management protocol . Classification of the pressure sore will be carried out at D7, D14, D28 or on the day of discharge from the intensive care unit | 30 minutes after the participant has been put back on his back after each prone session, then at D7, D14 and D28 or at discharge from intensive care if the participant has had a pressure sore |
| Compare the care required to apply, monitor and remove the two types of dressing | Time spent on each of the two care strategies in minutes | Three years |
| Compare the cost of medical devices, by dressing strategy, until VD sessions are discontinued | Overall cost of each care strategy. An assessment of the direct cost of dressings will be made on the basis of the number recorded for each patient | Three years |