Pressure Ulcers Prevention in Prone Positioning in Intensive CareDERM-H-PROTECTNCT06442657
Pressure Sore Prevention Strategy for the Prone Position
A study testing Hydrocellular dressing and Hydrocolloids dressing in people with Pressure Ulcers Prevention in Prone Positioning in Intensive Care, run by University Hospital, Caen at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Pressure Ulcers Prevention in Prone Positioning in Intensive Care
- What is being tested?
- Hydrocellular dressing and Hydrocolloids dressing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteFrance
- Study dates
- 18 Jun 2024to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnant or breast-feeding women
- Patient under guardianship or trusteeship
- Minor patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the 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.
- Being tested
- Hydrocellular dressing, Hydrocolloids dressing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrocellular dressingOther
Application of hydrocellular dressings to at-risk areas prior to prone positioning. Assessment of pressure sores and their stage after prone positioning.
Hydrocolloids dressingOther
Application of hydrocolloids dressings to at-risk areas prior to prone positioning.
| Study group | Role | What they receive |
|---|---|---|
| Hydrocellular | Experimental | Application of hydrocellular dressings prior to prone positioning and standard pressure sore prevention strategy. Dressings can remain in place for up to 7 days. Receives: Other: Hydrocellular dressing |
| Hydrocolloid | Active comparator | Application of hydrocolloids dressings prior to prone positioning and standard pressure sore prevention strategy. Dressings are removed after each prone position. Receives: Other: Hydrocolloids dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 minutes after being put back on its back
Secondary outcomes (5)
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).
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start18 Jun 2024
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure Ulcers Prevention in Prone Positioning in Intensive CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Agathe Hamelin, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06442657
- Sponsor's protocol ID
- 2023-A00932-43
- Acronym
- DERM-H-PROTECT
- Status last verified
- May 2024
- First submitted
- 22 May 2024
- Last updated
- 25 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06442657
- Acronym / sponsor ID
- DERM-H-PROTECT / 2023-A00932-43
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 18 Jun 2024 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 4 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrocellular | Experimental | Other: Hydrocellular dressingApplication of hydrocellular dressings prior to prone positioning and standard pressure sore prevention strategy. Dressings can remain in place for up to 7 days. |
| Hydrocolloid | Active comparator | Other: Hydrocolloids dressingApplication of hydrocolloids dressings prior to prone positioning and standard pressure sore prevention strategy. Dressings are removed after each prone position. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Pregnant or breast-feeding women
- Patient under guardianship or trusteeship
- Minor patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrocellular dressingApplication of hydrocellular dressings to at-risk areas prior to prone positioning. Assessment of pressure sores and their stage after prone positioning. | Other | Hydrocellular |
| Hydrocolloids dressingApplication of hydrocolloids dressings to at-risk areas prior to prone positioning. | Other | Hydrocolloid |
Primary outcome
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
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Agathe Hamelin principal investigator
University Hospital, Caen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrocellular dressing and Hydrocolloids dressing in people with Pressure Ulcers Prevention in Prone Positioning in Intensive Care, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Agathe Hamelin (02.31.06.47.11, hamelin-a@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.