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

INTRODUCTION Multiple studies have shown that Prone position (PP) alters the mechanics and physiology of gas exchange to result in improved oxygenation, especially if used early (first 48 hours) in appropriate patients. However, it´s carries complications, some associated with prolonged decubitus, as the pressure ulcers (PUs) on the pelvis, thorax, knees and face. Dressings and topical agents intended for the prevention of skin injuries are widely used. However, it is not clear which ones are most effective in preventing PUs in the prone patient. On the other hand, it is important to take into account the great impact that PUs have on the quality of life of patients, the increase in hospitalization times and the high costs involved, so it´s important to focus nursing care on their prevention. Given the current variability in the interchangeable use of hydrocolloid dressings (HCD) and hyperoxygenated fatty acids (HOFA) in the prevention of PUs in patients admitted to the ICU, and given that there is insufficient scientific evidence to support the use of one method of prevention versus the other when the critical patient is placed on PP, it was considered necessary to carry out a clinical trial.

HYPOTHESIS: PUs in Intensive Care Units have been shown to be multicausal, so that there is a great variability in the incidence of these diseases. For that reason, when establishing the comparison between HOFA methods and hydrocolloid dressings, it is expected to find a lower incidence with the use of HOFA.

METHODOLOGY Design: A randomized controlled clinical trial with two comparison groups will be performed (Group A: hyperoxygenated fatty acids;Group B: hydrocolloid dressing). Study period: prior to initiation of the multicenter phase, a 6-month pilot study (June-December 2021) was conducted at the coordinating center to assess the methodological and operational feasibility of the protocol, as well as to standardize recruitment, intervention, follow-up, and data collection procedures. During this period, a total of 26 patients were enrolled. From January 2022 to January 2026, an additional 200 subjects had been recruited. Subjects and study setting: Patients admitted to Intensive Care Units in hospitals participating in the project who are prescribed DP maneuver with signed or authorized consent from their referring family member. This is a multicenter study involving 7 ICUs from 7 hospitals in the National Health System: Puerta de Hierro Majadahonda University Hospital (leading center ECA), Torrejón University Hospital, La Princesa University Hospital, San Carlos Clinical University Hospital, La Paz University Hospital, Central University Hospital of Asturias, University Hospital of Navarra.

Randomization: All patients admitted to the ICU who meet the inclusion criteria will be randomized into two groups, according to a randomization list prepared by Care Research Unit from MPHUH before starting the study, using a pseudo-random number generator program (Epidat program version 3.1). The distribution will be revealed by means of opaque, numbered, sealed and correlated envelopes, at the time the study subject is recruited.

Before performing the PP maneuver, regardless of the assigned group, the hygiene and hydration care established by the Unit's protocols will be carried out. Subsequently, the care assigned to each group will be carried out. Once the group is assigned (HOFA or HCD), an infographic will be placed in the box with a summary of care to ensure continuity of care. In the event that more prone sessions are required, the same care assigned at the beginning will be maintained in the following sessions.