Clinical trial Recruiting at 1 site Interventional Ages 18 and up

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.

More Pressure Ulcer trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment262 (estimated)
SponsorPuerta de Hierro University Hospital
Academic / other
Locations1 site (Majadahonda, Madrid)
StatusRecruiting
StartedJune 12, 2021
Main results expectedDecember 2026
Study endsJuly 2027
Registry record updatedJuly 24, 2026
Trial IDNCT05198167 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

  • Majadahonda Puerta de Hierro University Hospital
    Majadahonda, Madrid, Spain
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.