Efficacy of Hyperoxygenated Fatty Acids Versus Hydrocolloid Dressings in the Prevention of Pressure Ulcers in Critically Ill Prone Patients

What this Trial Is About

Researchers are evaluating the effectiveness of two different skin care methods—Hyperoxygenated Fatty Acids (HOFA) and hydrocolloid dressings (HCD)—in preventing pressure ulcers in critically ill patients placed in the prone position. This randomized clinical trial focuses on patients admitted to intensive care units (ICUs) who require prone positioning, a treatment often used to improve oxygenation but which can lead to pressure ulcers and other complications. The study aims to determine which prevention method better reduces pressure ulcer occurrence and associated complications in these patients. The trial randomly assigns patients to one of two groups: one group receives HOFA applied to pressure-prone areas, while the other group receives hydrocolloid dressings for protection. Both groups follow a strict care protocol established by the ICU. This multicenter study involves several hospitals and includes training for ICU staff to ensure consistent care and data collection. The intervention starts before prone positioning and continues during all prone sessions required during the ICU stay. Participants undergo assessments before, during, and after each prone session, with data collected on pressure ulcer occurrence, location, severity, and other clinical variables. Data is recorded in a secure digital database by clinical research teams. The primary outcome measured is the presence of pressure ulcers within 24 hours of prone positioning. The study includes continuous monitoring for adverse events and follows patients through their ICU stay until the required sample size is reached, with study completion expected by July 2027.

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