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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pressure Ulcers Prevention in Prone Positioning in Intensive Care
• Intervention / Treatment: Other: Hydrocellular dressing; Other: Hydrocolloids dressing

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.

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Agathe Hamelin; Phone Number: 02.31.06.47.11; Email: hamelin-a@chu-caen.fr
• Study Contact Backup: Name: Clémence Tomadesso; Phone Number: 02 31 06 53 86; Email: tomadesso-c@chu-caen.fr

Study Locations

• France
  • Caen, France, 14000
    • Recruiting
    • CHU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hydrocellular; Application of hydrocellular dressings prior to prone positioning and standard pressure sore prevention strategy. Dressings can remain in place for up to 7 days.	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.
Active Comparator: Hydrocolloid; Application of hydrocolloids dressings prior to prone positioning and standard pressure sore prevention strategy. Dressings are removed after each prone position.	Other: Hydrocolloids dressing; Application of hydrocolloids dressings to at-risk areas prior to prone positioning.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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	30 minutes after being put back on its back

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare the location of pressure sores between the two groups	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).	30 minutes after putting the participant back on his back
Compare the severity of pressure sores between the two groups	Severity of pressure sore according to NPUAP classification (stages 1 to 4)	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.	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	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 spent on each of the two care strategies in minutes	Three years
Compare the cost of medical devices, by dressing strategy, until VD sessions are discontinued	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	Three years

Collaborators and Investigators

• Sponsor: University Hospital, Caen
• Investigators: Principal Investigator: Agathe Hamelin, CHU CAEN

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: May 22, 2024
• First Submitted That Met QC Criteria: June 3, 2024
• First Posted (Actual): June 4, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 24, 2025
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Ulcer; Pressure Ulcer
• Other Study ID Numbers: 2023-A00932-43

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No