Pressure Sore Prevention Strategy for the Prone Position
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hydrocellular dressing, Hydrocolloids dressing.
- Who it may be relevant to
- Registry conditions: Pressure Ulcers Prevention in Prone Positioning in Intensive Care. Basic parameters: 18 years — 110 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Other Hydrocellular dressing
Application of hydrocellular dressings to at-risk areas prior to prone positioning. Assessment of pressure sores and their stage after prone positioning. - Other Hydrocolloids dressing
Application of hydrocolloids dressings to at-risk areas prior to prone positioning.
Primary outcome measures
- 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]
Secondary outcome measures (5)
- Compare the location of pressure sores between the two groups [Time frame: 30 minutes after putting the participant back on his back]
- Compare the severity of pressure sores between the two groups [Time frame: 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. [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]
- Compare the care required to apply, monitor and remove the two types of dressing [Time frame: Three years]
- Compare the cost of medical devices, by dressing strategy, until VD sessions are discontinued [Time frame: Three years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
France · 1 center
- CHU — Caen
Identifiers
NCT: NCT06442657 · 2023-A00932-43