CHU
Caen, 14000, France
Location status: Recruiting
Recruiting
NCT Number: NCT06442657
Pressure Sore Prevention Strategy for the Prone Position
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.
Recruiting
Interested in participating?
Request InfoKey information
Age range
18 year–110 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Hydrocellular dressing
OtherApplication of hydrocellular dressings to at-risk areas prior to prone positioning. Assessment of pressure sores and their stage after prone positioning.
Hydrocolloids dressing
OtherApplication of hydrocolloids dressings to at-risk areas prior to prone positioning.
Primary outcomes
-
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 frame: 30 minutes after being put back on its back
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
Secondary outcomes
-
Compare the location of pressure sores between the two groups
Time frame: 30 minutes after putting the participant back on his back
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).
-
Compare the severity of pressure sores between the two groups
Time frame: 30 minutes after putting the participant back on his back
Severity of pressure sore according to NPUAP classification (stages 1 to 4)
-
Compare the evolution of pressure sores between the two groups up to discharge from the intensive care unit.
Time frame: 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
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
-
Compare the care required to apply, monitor and remove the two types of dressing
Time frame: Three years
Time spent on each of the two care strategies in minutes
-
Compare the cost of medical devices, by dressing strategy, until VD sessions are discontinued
Time frame: Three years
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
Study contacts
Contact information is provided by the study sponsor or research team.
Agathe Hamelin
CONTACT
Clémence Tomadesso
CONTACT
Sponsors and collaborators
Lead sponsor
University Hospital, Caen
Other
Registry information
Official study 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
Acronym: DERM-H-PROTECT
Important dates
- Study start
- 2024
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Jun 4, 2024
- Registry last updated
- Mar 25, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.