Peripheral Tissue Perfusion and Oxygenation in Areas at Risk of Press Ulcer (POTER-OIL)

Summary

The study objectives will be:

Primary objectives:

1. To determine the effects on oxygenation and tissue perfusion of applying HFA (Hyperoxygenated Fatty Acids) or EVOO (Extra Virgin Olive Oil) to the heels of healthy subjects, evaluating the maximum variation of oxygenation and flow when the heels are subjected to pressure.
2. To determine the levels of tissue oxygenation and perfusion associated with the appearance of blanching erythema in the heels of acute hospitalised patients and patients admitted to social health centers for the elderly.

Secondary objectives:

1. To determine whether there are differences in oxygenation and peripheral tissue perfusion between heels to which HFA vs. EVOO is applied.
2. To evaluate the possible progressive loss of the efficacy of HFA and EVOO in terms of tissue oxygenation and perfusion in patients who are bedridden for extended periods.

Methodology:

Experimental study in two phases: preclinical and clinical. Phase 1 with healthy subjects, with a randomized and open design, with an intrasubject control group. Phase 2 with hospitalized subjects and patients admitted to social health centers for the elderly, with a randomized and open design, with an intrasubject control group.

Conditions

• Pressure Ulcer

Interventions

OTHER

MEPENTOL® AND FARMAOLIVA® IN HEALTHY WITH INTRASUBJECT CONTROL

The corresponding product (HFA -Mepentol®- or EVOO - Farmaoliva®- depending on the study group assigned) will be applied to the subject's right heel, while the contralateral, left, heel will remain as a control. To ensure that the product is completely absorbed into the skin, the subject will then be asked to remain lying face up, at an angle of 30º to the bed, for one hour. The Doppler and infrared laser probes will then be placed on each heel (on the calcaneal tuberosity), for approximately four hours. The subjects will be asked to keep their lower body immobile, but will be able to move their arms and neck gently. Average values for capillary blood flow, local temperature and tissue oxygenation will be collected at 15-minute intervals, although the first 15-minute reading, while the parameters are becoming established, will be discarded.

OTHER

MEPENTOL® AND FARMAOLIVA® IN PATIENTS WITH INTRASUBJECT CONTROL

In the second, clinical phase, the measurement protocol will be different, although certain aspects will remain unchanged. The product in question (HFA -Mepentol®- or EVOO -Farmaoliva®- according to the randomisation group assigned) will be applied to the intervention heel (right), leaving the contralateral (left) heel as a control. In addition, every patient will receive the standard PU prevention measures described in the protocol applicable for persons at risk of this condition. The intervention will be carried out in the morning, after bathing, as is customary in acute-care hospital units. The data will be collected at 15-minute intervals, although the first interval will be discarded, as described above. This procedure will be repeated every day during hospitalisation, to assess the cumulative action of the barrier cream. Each measurement will last approximately one hour each day.

Sponsors & Collaborators

• JOSE MIGUEL MORALES ASENCIO

  lead OTHER

Principal Investigators

• Inmaculada Lupiáñez Pérez, PhD · Faculty of Health Sciences, University of Málaga, Spain

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-01-04

Primary Completion

2023-06-01

Completion

2024-12-31