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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPuerta de Hierro University Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Hyperoxygenated fatty acids

    Other intervention

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

  • Hydrocolloid dressings

    Other intervention

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

Treatment groups

262 Participants
are divided into 2 treatment groups
Group A: Hyperoxygenated Fatty AcidsExperimental treatment 1 intervention
Group B: Hydrocolloid dressingsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Pressure ulcers

The main outcome variable will be the appearance of pressure ulcers, location, extension and severity

Time frame
24 hours

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Puerta de Hierro University Hospital

Lead sponsor

Ministry of Health, Spain

Collaborator

Carlos III Health Institute

Collaborator

Sociedad Española de Enfermería Intensiva y Unidades Coronarias

Collaborator