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

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.

NCT Number	NCT05198167
Lead Sponsor	Puerta de Hierro University Hospital Collaborators: Ministry of Health, Spain, Carlos III Health Institute, Sociedad Española de Enfermería Intensiva y Unidades Coronarias
Conditions	Prone Position, Pressure Ulcer
Enrollment	262 participants
Start Date	2021-06-12
Primary Completion	2026-12 (estimated)
Study Completion	2027-07 (estimated)
Updated on ClinicalTrials.gov	2026-07-24