Pressure Sore Prevention Strategy for the Prone Position (DERM-H-PROTECT)

Caen University Hospital

Status: Enrolling

Conditions: Pressure Ulcers Prevention in Prone Positioning in Intensive Care

Treatments: Other: Hydrocellular dressing; Other: Hydrocolloids dressing

Study type: Interventional

Funder types: Other

Identifiers

NCT06442657

2023-A00932-43

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 110 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

Hydrocellular

Experimental group

Description:

Application of hydrocellular dressings prior to prone positioning and standard pressure sore prevention strategy. Dressings can remain in place for up to 7 days.

Treatment:

Other: Hydrocellular dressing

Hydrocolloid

Active Comparator group

Description:

Application of hydrocolloids dressings prior to prone positioning and standard pressure sore prevention strategy. Dressings are removed after each prone position.

Treatment:

Other: Hydrocolloids dressing