Evidence map›Paper›PMID 31475465›Full record

Trial reportInternational wound journal2019

Effectiveness and safety of olive oil preparation for topical use in pressure ulcer prevention: Multicentre, controlled, randomised, and double-blinded clinical trial.

Antonio Díaz-Valenzuela, Francisco P García-Fernández, PedroJ Carmona Fernández, M Jesús Valle Cañete, Pedro L Pancorbo-Hidalgo

Registry-linked trialOpen access · greenAbstract readMulticenter StudyRandomized Controlled TrialEquivalence Trial
In one paragraph

Trial report in International wound journal, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05144646 (Peripheral Tissue Perfusion and Oxygenation in Areas at Risk of Deterioration of Skin Integrity Subjected to Treatment With Hyperoxygenated Fatty Acids vs Virgin Olive Oil), which is not on this map. Cited by 11 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 2 pooled it
8.7field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05144646 naunknown statusnot on this mapstarted 2022, after this paper: background citation

Peripheral Tissue Perfusion and Oxygenation in Areas at Risk of Deterioration of Skin Integrity Subjected to Treatment With Hyperoxygenated Fatty Acids vs Virgin Olive Oil

TypeinterventionalSponsorJOSE MIGUEL MORALES ASENCIORan2022 to 2024Enrolled46ConditionsPressure UlcerArmsMEPENTOL® AND FARMAOLIVA® IN HEALTHY WITH INTRASUBJECT CONTROL, MEPENTOL® AND FARMAOLIVA® IN PATIENTS WITH INTRASUBJECT CONTROL
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 2 syntheses or guidelines pooled it, 30 citations in OpenAlex.

  1. Dressings and topical agents for preventing pressure ulcers.The Cochrane database of systematic reviews · 2024
    Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Review
  6. Article
  7. An Ayurvedic approach to sustaining and pampering the feet of healthcare workers.Journal of interprofessional education & practice · 2022
    Article
  8. Article
  9. Article
  10. Review
  11. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 3 institutions in 1 country.

Antonio Díaz-ValenzuelaAgencia Sanitaria Alto Guadalquivir, Hospital Puente Genil, Puente Genil, Córdoba, Spain.ORCID https://orcid.org/0000-0002-5878-2274
Francisco P García-FernándezComplejo Hospitalario de Jaén. Care Strategy Unit, Jaén, Spain.
PedroJ Carmona FernándezAgencia Sanitaria Alto Guadalquivir, Hospital Puente Genil, Puente Genil, Córdoba, Spain.
M Jesús Valle CañeteAgencia Sanitaria Alto Guadalquivir, Hospital Puente Genil, Puente Genil, Córdoba, Spain.
Pedro L Pancorbo-HidalgoUniversidad de Jaén, Nursing Department, Jaén, Andalusia, Spain.ORCID https://orcid.org/0000-0002-0092-6095
Hospital Alto Guadalquivir · ESUniversidad de Jaén · ESComplejo Hospitalario de Jaén · ES

Funding

Fundación Progreso y Salud, Consejería de Salud de la Junta de Andalucía (Spain) PI-0772-2010
6 · The paper itself

Abstract

This non-inferiority, multicentre, randomised, controlled, and double-blinded clinical trial compared the therapeutic effectiveness of the topical application of an olive oil solution with that of a hyperoxygenated fatty acid compound for the prevention of pressure ulcers in at-risk nursing home residents. The study population comprised 571 residents of 23 nursing homes with pressure ulcer risk, randomly assigned to a hyperoxygenated fatty acid group (n = 288) or olive oil solution group (n = 283). Both solutions were applied on at-risk skin areas every 12 hours for 30 days or until pressure ulcer onset. The main outcome variable was the pressure ulcer incidence. The absolute risk difference was estimated (with 95% CI) using Kaplan-Meier survival and Cox regression curves. The groups did not significantly differ in any study variable at baseline. The pressure ulcer incidence was 4.18% in the olive oil group vs 6.57% in the control group, with an incidence difference of -2.39% (95% CI = -6.40 to 1.56%), which is within the pre-established non-inferiority margin of ±7%, thus supporting the study hypothesis. We present the first evidence of the effectiveness and safety of the topical application of olive oil to prevent pressure ulcers in the institutionalised elderly.

Indexed as

Administration, TopicalAged, 80 and overDouble-Blind MethodFatty AcidsFemaleHumansIncidenceMaleNursing HomesOlive OilPressure UlcerSpainFatty AcidsOlive Oilhyperoxygenated fatty acidsnon-inferiority clinical trialolive oilpressure ulcersskin care

Identifiers

PMID31475465
PMCPMC7949451
OpenAlexW2971991081

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.