NCT05198167 Efficacy of HOFA Versus Hydrocolloid Dressings in the Prevention of PUs in Critically Ill Prone Patients
| NCT ID | NCT05198167 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Puerta de Hierro University Hospital |
| Condition | Prone Position |
| Study Type | INTERVENTIONAL |
| Enrollment | 262 participants |
| Start Date | 2021-06-12 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 262 participants in total. It began in 2021-06-12 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Contact & Investigator
Leire Maculet-García, RN
PRINCIPAL INVESTIGATOR
Hospital Universitario Puerta de Hierro
Frequently Asked Questions
Who can join the NCT05198167 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Prone Position. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05198167 currently recruiting?
Yes, NCT05198167 is actively recruiting participants. Contact the research team at leire.maculet@salud.madrid.org for enrollment information.
Where is the NCT05198167 trial being conducted?
This trial is being conducted at Majadahonda, Spain.
Who is sponsoring the NCT05198167 clinical trial?
NCT05198167 is sponsored by Puerta de Hierro University Hospital. The principal investigator is Leire Maculet-García, RN at Hospital Universitario Puerta de Hierro. The trial plans to enroll 262 participants.