Preventing pressure sores in patients positioned face down in intensive care
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
This study tests whether a new type of dressing can better prevent pressure sores in patients lying face down in intensive care compared to a standard dressing.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years to 110 Years |
| Sex | All |
| Sponsor | University Hospital, Caen Academic / other |
| Locations | 1 site (Caen) |
| Trial ID | NCT06442657 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of 5-layer hydrocellular dressings compared to hydrocolloid dressings in preventing pressure sores in patients placed in the prone position in the intensive care unit. Participants will receive either type of dressing, and caregivers will monitor for the development of pressure sores in at-risk areas. The study will also assess the time and cost associated with each dressing strategy. The goal is to determine if hydrocellular dressings are a simpler and more cost-effective solution for pressure sore prevention.
Who should consider this trial
Good fit: Ideal candidates for this study are adults with moderate to severe acute respiratory distress syndrome who are sedated and on mechanical ventilation.
Not a fit: Patients who are pregnant, breastfeeding, or minors will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prevention of pressure sores in critically ill patients, enhancing their overall care and recovery.
How similar studies have performed: Other studies have explored various dressing types for pressure sore prevention, but this specific comparison of hydrocellular versus hydrocolloid dressings in the prone position is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Caen
- Chu — Caen, France (Recruiting)
Study contacts
- Principal investigator: Agathe Hamelin — University Hospital, Caen
- Study coordinator: Agathe Hamelin
- Email: hamelin-a@chu-caen.fr
- Phone: 02.31.06.47.11
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.