Clinical trial NCT06442657: Pressure Sore Prevention Strategy for the Prone Position
Official title: Comparison of Two Care Strategies (5-layer Hydrocellular Dressings Versus Thick Hydrocolloid Dressings) in Preventing the Development of Pressure Sore Lesions Induced by Prone Positioning in Intensive Care Patients. Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pressure Ulcers Prevention in Prone Positioning in Intensive Care
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2024-06-04
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Major patient
* Moderate to severe acute respiratory distress syndrom (Arterial oxygen pressure /Inspired Fraction of oxygen ratio \< 200) requiring at least one VD session.
* Affiliated to the French social security system
* Sedated patient on mechanical ventilation

Exclusion Criteria:

* Pregnant or breast-feeding women
* Patient under guardianship or trusteeship
* Minor patients

Primary outcomes:
measure: 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)
timeFrame: 30 minutes after being put back on its back
Secondary outcomes:
measure: Compare the location of pressure sores between the two groups
timeFrame: 30 minutes after putting the participant back on his back
measure: Compare the severity of pressure sores between the two groups
timeFrame: 30 minutes after putting the participant back on his back
measure: Compare the evolution of pressure sores between the two groups up to discharge from the intensive care unit.
timeFrame: 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
measure: Compare the care required to apply, monitor and remove the two types of dressing
timeFrame: Three years
measure: Compare the cost of medical devices, by dressing strategy, until VD sessions are discontinued
timeFrame: Three years
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU
Study officials:
affiliation: CHU CAEN
name: Agathe Hamelin
role: PRINCIPAL_INVESTIGATOR
References: