Pressure Sore Prevention Strategy for the Prone Position

Last updated: March 24, 2025
Sponsor: University Hospital, Caen
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pressure Ulcer

Treatment

Hydrocellular dressing

Hydrocolloids dressing

Clinical Study ID

NCT06442657
2023-A00932-43
  • Ages 18-110
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Pregnant or breast-feeding women

  • Patient under guardianship or trusteeship

  • Minor patients

Study Design

Total Participants: 180
Treatment Group(s): 2
Primary Treatment: Hydrocellular dressing
Phase:
Study Start date:
June 18, 2024
Estimated Completion Date:
July 31, 2027

Study 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.

Connect with a study center

  • CHU

    Caen, 14000
    France

    Active - Recruiting

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