NCT05198167

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
262

participants targeted

Target at P75+ for not_applicable

Timeline
13mo left

Started Jun 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Jun 2021Jul 2027

Study Start

First participant enrolled

June 12, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 15, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 20, 2022

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

May 15, 2026

Status Verified

May 1, 2026

Enrollment Period

5.5 years

First QC Date

December 15, 2021

Last Update Submit

May 12, 2026

Conditions

Pressure UlcerProne Position

Keywords

Nursing CareFatty acidsPreventionComplications

Outcome Measures

Primary Outcomes (1)

  • Pressure ulcers

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

    24 hours

Study Arms (2)

Hyperoxygenated Fatty Acids

EXPERIMENTAL

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

Other: Hyperoxygenated fatty acids

Hydrocolloid dressings

EXPERIMENTAL

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

Other: Hydrocolloid dressings

Interventions

Hyperoxygenated fatty acidsOTHER

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

Hyperoxygenated Fatty Acids
Hydrocolloid dressingsOTHER

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

Hydrocolloid dressings

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with previous pressure ulcers in the following prone-related locations: shoulders, thorax, genitals, iliac crest, knees, ankles, facial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Majadahonda Puerta de Hierro University Hospital

Majadahonda, Madrid, 28222, Spain

RECRUITING

Related Publications (6)

  • Araujo MS, Santos MMPD, Silva CJA, Menezes RMP, Feijao AR, Medeiros SM. Prone positioning as an emerging tool in the care provided to patients infected with COVID-19: a scoping review. Rev Lat Am Enfermagem. 2021 Jan 8;29:e3397. doi: 10.1590/1518-8345.4732.3397. eCollection 2021.

    PMID: 33439949BACKGROUND

  • Why Prone? Why Now? Improving Outcomes for ARDS Patients. Crit Care Nurse. 2019 Oct;39(5):84. doi: 10.4037/ajcc2019878. No abstract available.

    PMID: 31575599BACKGROUND

  • Perrillat A, Foletti JM, Lacagne AS, Guyot L, Graillon N. Facial pressure ulcers in COVID-19 patients undergoing prone positioning: How to prevent an underestimated epidemic? J Stomatol Oral Maxillofac Surg. 2020 Sep;121(4):442-444. doi: 10.1016/j.jormas.2020.06.008. Epub 2020 Jun 18.

    PMID: 32565264BACKGROUND

  • Tayyib N, Coyer F. Effectiveness of Pressure Ulcer Prevention Strategies for Adult Patients in Intensive Care Units: A Systematic Review. Worldviews Evid Based Nurs. 2016 Dec;13(6):432-444. doi: 10.1111/wvn.12177. Epub 2016 Oct 6.

    PMID: 27712030BACKGROUND

  • Lima Serrano M, Gonzalez Mendez MI, Carrasco Cebollero FM, Lima Rodriguez JS. Risk factors for pressure ulcer development in Intensive Care Units: A systematic review. Med Intensiva. 2017 Aug-Sep;41(6):339-346. doi: 10.1016/j.medin.2016.09.003. Epub 2016 Oct 22. English, Spanish.

    PMID: 27780589BACKGROUND

  • Tayyib N, Coyer F, Lewis P. Saudi Arabian adult intensive care unit pressure ulcer incidence and risk factors: a prospective cohort study. Int Wound J. 2016 Oct;13(5):912-9. doi: 10.1111/iwj.12406. Epub 2015 Feb 9.

    PMID: 25662591BACKGROUND

Related Links

MeSH Terms

Conditions

Pressure Ulcer

Interventions

Bandages, Hydrocolloid

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

BandagesEquipment and Supplies

Study Officials

  • Leire Maculet-García, RN

    Hospital Universitario Puerta de Hierro

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Leire Maculet-García, RN

CONTACT

+34 618704761leire.maculet@salud.madrid.org

Montserrat Solís-Muñoz, PhD, MSc, RN

CONTACT

+34 911917457montserrat.solis@salud.madrid.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
In this type of study, the aim is to guarantee internal validity by minimizing possible biases, which is why it is important to guarantee the randomization process and the measurement of variables with objectivity criteria. This type of clinical trial does not allow masking the person who performs the intervention, nor the person who measures the main outcome variable, since given the type of patient and the specific care required, it is not possible for a professional outside the patient's care to carry out the assessment of the patient. Blinded analysis of the patients will be guaranteed.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: * Group A: Application of hyperoxygenated fatty acids. * Group B: Protection of pressure areas with hydrocolloid dressing.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Registered Nurse

Study Record Dates

First Submitted

December 15, 2021

First Posted

January 20, 2022

Study Start

June 12, 2021

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

July 1, 2027

Last Updated

May 15, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)