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Recruiting NCT05198167

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

Conditions: Prone Position, Pressure Ulcer

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 262
Sponsor: Puerta de Hierro University Hospital

Location: Majadahonda Puerta de Hierro University Hospital Majadahonda Madrid

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 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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05198167). StuddyBuddy aggregates publicly available trial information.