HOFA vs hydrocolloid dressings to prevent pressure ulcers in patients in the prone position
Official title: Efficacy of Hyperoxygenated Fatty Acids Versus Hydrocolloid Dressings in the Prevention of Pressure Ulcers in Critically Ill Prone Patients
Run by Puerta de Hierro University Hospital · NCT05198167 · Data updated 2026-11-12
This trial tests whether hyperoxygenated fatty acids (HOFA) can better prevent pressure ulcers than hydrocolloid dressings in critically ill patients who are kept in a prone position.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 262 (estimated) |
| Sponsor | Puerta de Hierro University Hospital Academic / other |
| Locations | 1 site (Majadahonda, Madrid) |
| Status | Recruiting |
| Started | June 12, 2021 |
| Main results expected | December 2026 |
| Study ends | July 2027 |
| Registry record updated | July 24, 2026 |
| Trial ID | NCT05198167 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Critically ill adults in the ICU who are being placed in the prone position and can consent or have consent provided by a family member.
✕Probably not a fit
Patients who have existing pressure ulcers in prone-related locations or are not at risk for skin breakdown may not benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In this randomized trial, critically ill patients in the ICU who require prone positioning for ARDS management will be assigned to HOFA or hydrocolloid dressings to prevent pressure ulcers. The study compares the two skin-protection approaches and tracks the occurrence of pressure ulcers and related complications. The aim is to determine which method more effectively reduces skin injuries in the pelvis, thorax, knees, and face during prolonged prone positioning. The trial is conducted at Puerta de Hierro University Hospital in collaboration with health authorities in Spain. Results may inform best practices for skin care in prone patients and reduce morbidity from pressure injuries.
Why it matters
Potential benefit: If HOFA proves more effective, patients could experience fewer pressure ulcers and related complications during prolonged prone positioning.
How similar studies have gone: Previous research has explored dressings and topical agents for PU prevention, but direct head-to-head evidence in prone ICU patients is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: All patients in prone position admitted to participating ICU who agree to be included in the study or, if they are unable to communicate, the consent is authorized by their referring family member. Exclusion Criteria: Patients with previous pressure ulcers in the following prone-related locations: shoulders, thorax, genitals, iliac crest, knees, ankles, facial.
Where it's running
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Majadahonda Puerta de Hierro University Hospital
Majadahonda, Madrid, Spain Recruiting
Study contacts
- Principal investigator: Leire Maculet-García, RN — Hospital Universitario Puerta de Hierro
- Study coordinator: Leire Maculet-García, RN
- Email: leire.maculet@salud.madrid.org
- Phone: +34 618704761
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.