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

NCT05198167 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 262

Last updated 2026-05-15

No results posted yet for this study

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.

Conditions

  • Prone Position
  • Pressure Ulcer

Interventions

OTHER

Hyperoxygenated fatty acids

Application of hyperoxygenated fatty acids in pressure zones for prevention of prone position pressure ulcers

OTHER

Hydrocolloid dressings

Protection of pressure areas with hydrocolloid dressings for the prevention of prone pressure ulcers

Sponsors & Collaborators

  • Ministry of Health, Spain

    collaborator OTHER_GOV
  • Carlos III Health Institute

    collaborator OTHER_GOV
  • Sociedad Española de Enfermería Intensiva y Unidades Coronarias

    collaborator UNKNOWN
  • Puerta de Hierro University Hospital

    lead OTHER

Principal Investigators

  • Leire Maculet-García, RN · Hospital Universitario Puerta de Hierro

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-12
Primary Completion
2026-12-31
Completion
2027-07-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05198167 on ClinicalTrials.gov