Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Clinical Trials in Spain / NCT05198167
Recruiting Not applicable

Efficacy of HOFA Versus Hydrocolloid Dressings in the Prevention of PUs in Critically Ill Prone Patients

NCT05198167 · tracked via the Priya Life Science Spain tracker
Sponsor
Puerta de Hierro University Hospital
Phase
Not applicable
Started
2021-06-12
Last updated
2026-07-24

Condition(s) studied

Prone PositionPressure Ulcer

Investigational drug(s) / intervention(s)

Hyperoxygenated fatty acidsHydrocolloid dressings

Hyperoxygenated fatty acids: Application of hyperoxygenated fatty acids in pressure zones for prevention of prone position pressure ulcers

Hydrocolloid dressings: Protection of pressure areas with hydrocolloid dressings for the prevention of prone pressure ulcers

Study summary

Introduction: Prone position (PP) treatment as a rescue strategy for patients with acute respiratory distress syndrome (ARDS) is a technique increasingly used in our daily practice and, as a result of the current health situation due to SARS COV-2, has become the treatment of choice for many patients. Many of the associated complications can be considerably reduced with the implementation of standardized procedures and a team trained and specialized in this technique and its subsequent care.

Aim: To evaluate the efficacy of the use of Hyperoxygenated Fatty Acids (HOFA) compared to the use of hydrocolloid dressings (HCD) in the prevention of Pressure ulcers (PUs) occurrence in critically ill patients in prone position.

Methods: A randomized clinical trial will be conducted to compare the occurrence of PUs and other complications in patients undergoing PP in the ICU of the HUPHM. Two care groups will be formed in which HOFA and hydrocolloid dressings will be used, respectively, following a strict care protocol previously established in the unit. In addition, other variables related to medical and nursing treatment that may influence the appearance of PUs and other complications associated with PP will also be analyzed.

Scientific relevance: PUs have a major socioeconomic and quality of life impact on patients. Dressings and topical agents for prevention are widely used, however, it is unclear which treatment is most effective in preventing PUs in the prone patient.

Keywords: Prone Position; Nursing care; Pressure ulcer; Fatty acids; Prevention; Complications.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Pressure ulcers — 24 hours
    The main outcome variable will be the appearance of pressure ulcers, location, extension and severity

Trial sites (1)

FacilityCityRegionStatus
Majadahonda Puerta de Hierro University Hospital Majadahonda Madrid Recruiting

More Puerta de Hierro University Hospital trials in Spain

Effect of Acetazolamide on Diuresis and Natriuresis in Patients With Acute Heart Failure (SANDI STUDY) Recruiting
Impact of Cardiac Rehabilitation Adapted for Patients With Heart Failure Starting soon
TRIMODAL PREHABILITATION IN GASTROINTESTINAL CANCER Recruiting
Effect of Angiotensin Receptor/Neprilysin Inhibitors on Transthyretin Cardiac Amyloidosis and Heart Failure with Reduced Ejection Fraction Starting soon
REACTION-VAD Trial: Remote Exercise Training Via Telemedicine in Patients With Long-Term Ventricular Assist Devices Starting soon

Other trials for the same condition

THERAVEX Tissue Care Spray Plus for the Management of Cutaneous Wounds, Burns, and Chronic Ulcers Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05198167 on ClinicalTrials.gov ↗ ← All trials in Spain