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The study objectives will be:
Primary objectives:
Secondary objectives:
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.
The study participants will be subjected to simple randomisation to receive HFA or EVOO . The phase 1 will be carried out in healthy volunteers recruited at the Faculty of Health Sciences in the University of Malaga (Spain). Inclusion criteria: Healthy volunteers, aged >20 years, with no cardiovascular, neurological, digestive, endocrine, renal, gynaecological, respiratory, haematological, infectious, dermatological, autoimmune or osteomuscular diseases diagnosed, nor functional limitations, with objective tissue integrity, BMI of 18.5-25.9 kg/cm2 and no scars on the heels.
The phase 2 will be carried out patients admitted to acute hospitalised patients and patients admitted to social health centers for the elderly, at risk of deterioration of skin integrity according to Braden score <16, no presence of PU, who agree to participate in the study.
Measurement instruments Perfusion and tissue temperature data will be obtained by laser doppler flowmetry (LDF), with MoorVMS-LDF equipment. This system has two monitoring probes (one for each heel) that are brought into contact with the skin. The laser light is transmitted through an optical fibre to the tissue, reaching a depth of approximately 1 mm. The scattered light is collected by optical fibres and, at the same time, transmitted to a photodetector. The system has a measuring range of 5-50º C, a resolution of 0.1º C and an accuracy of ± 0.3º C.
Tissue oxygenation will be measured by near-infrared spectroscopy, with the MoorVMS-NIRS instrument. As in the previous case, the system contains two monitoring probes that are placed in contact with the skin. This method measures oxygen saturation (SpO2), which is calculated from absolute concentrations of oxygenated and deoxygenated haemoglobin in the tissue. Each probe consists of a detector head, containing two identical photodiodes, and an emitter head, with two infrared LEDs that emit light at approximately 750-850 nm. The system has a measurement range of 0-99%, a resolution of 1% and an accuracy of ± 3%.
All information on capillary blood flow, local temperature and tissue oxygenation will be monitored continuously and simultaneously using appropriate software. All measurement procedures are non-invasive. Both Moor instruments are certified to ISO 13485: 2016.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HEALTHY SUBJECTS | Experimental | With healthy subjects in a randomised, open experimental design, in an intrasubject control group (application of HFA / EVOO on one heel, using the contralateral heel as a control and evaluating oxygenation and tissue perfusion in both cases). This intervention would correspond to phase 1 |
|
| PATIENTS | Experimental | With hospitalised patients and patients from social and health centers an experimental, randomised, open design, also with an intrasubject control group (application of HFA / EVOO on one heel, using the contralateral heel as a control and evaluating oxygenation and tissue perfusion in both cases). This intervention would correspond to phase 2. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEPENTOL® AND FARMAOLIVA® IN HEALTHY WITH INTRASUBJECT CONTROL | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Perfusion and tissue temperature | Perfusion and tissue temperature data will be obtained by laser doppler flowmetry (LDF), with MoorVMS-LDF equipment. This system has two monitoring probes (one for each heel) that are brought into contact with the skin. The laser light is transmitted through an optical fibre to the tissue, reaching a depth of approximately 1 mm. The scattered light is collected by optical fibres and, at the same time, transmitted to a photodetector. The system has a measuring range of 5-50º C, a resolution of 0.1º C and an accuracy of ± 0.3º C. | In the healthy group, measurements will be made for four hours at fifteen-minute intervals for 1 day. In the hospitalized patients group, measurements will be made for one hour at fifteen-minute intervals every day for 7 days. |
| Tissue oxygenation | Tissue oxygenation will be measured by near-infrared spectroscopy, with the MoorVMS-NIRS instrument. As in the previous case, the system contains two monitoring probes that are placed in contact with the skin. This method measures oxygen saturation (SpO2), which is calculated from absolute concentrations of oxygenated and deoxygenated haemoglobin in the tissue. Each probe consists of a detector head, containing two identical photodiodes, and an emitter head, with two infrared LEDs that emit light at approximately 750-850 nm. The system has a measurement range of 0-99%, a resolution of 1% and an accuracy of ± 3%. | In the healthy group, measurements will be made for four hours at fifteen-minute intervals for 1 day. In the hospitalized patients group, measurements will be made for one hour at fifteen-minute intervals every day for 7 days. |
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PHASE ONE HEALTHY SUBJECTS
Inclusion criteria:
Exclusion criteria:
PHASE TWO - PATIENTS
Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Inmaculada Lupiáñez Pérez, PhD | Contact | 651563914 | inmalupianez@uma.es |
| Name | Affiliation | Role |
|---|---|---|
| Inmaculada Lupiáñez Pérez, PhD | Faculty of Health Sciences, University of Málaga, Spain | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32924821 | Background | Avsar P, Moore Z, Patton D, O'Connor T, Budri AM, Nugent L. Repositioning for preventing pressure ulcers: a systematic review and meta-analysis. J Wound Care. 2020 Sep 2;29(9):496-508. doi: 10.12968/jowc.2020.29.9.496. | |
| 29474407 | Background | Bail K, Draper B, Berry H, Karmel R, Goss J. Predicting excess cost for older inpatients with clinical complexity: A retrospective cohort study examining cognition, comorbidities and complications. PLoS One. 2018 Feb 23;13(2):e0193319. doi: 10.1371/journal.pone.0193319. eCollection 2018. |
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| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C479536 | Mepentol |
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|
| MEPENTOL® AND FARMAOLIVA® IN PATIENTS WITH INTRASUBJECT CONTROL | Other | 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. |
|
| 23375662 | Background | Coleman S, Gorecki C, Nelson EA, Closs SJ, Defloor T, Halfens R, Farrin A, Brown J, Schoonhoven L, Nixon J. Patient risk factors for pressure ulcer development: systematic review. Int J Nurs Stud. 2013 Jul;50(7):974-1003. doi: 10.1016/j.ijnurstu.2012.11.019. Epub 2013 Feb 1. |
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| 31264345 | Background | Gaspar S, Peralta M, Marques A, Budri A, Gaspar de Matos M. Effectiveness on hospital-acquired pressure ulcers prevention: a systematic review. Int Wound J. 2019 Oct;16(5):1087-1102. doi: 10.1111/iwj.13147. Epub 2019 Jul 1. |
| 31651050 | Background | Gomez-Gonzalez AJ, Morilla-Herrera JC, Lupianez-Perez I, Morales-Asencio JM, Garcia-Mayor S, Leon-Campos A, Marfil-Gomez R, Aranda-Gallardo M, Moya-Suarez AB, Kaknani-Uttumchandani S. Perfusion, tissue oxygenation and peripheral temperature in the skin of heels of healthy participants exposed to pressure: a quasi-experimental study. J Adv Nurs. 2020 Feb;76(2):654-663. doi: 10.1111/jan.14250. Epub 2019 Nov 20. |
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| 16984577 | Background | Lindgren M, Malmqvist LA, Sjoberg F, Ek AC. Altered skin blood perfusion in areas with non blanchable erythema: an explorative study. Int Wound J. 2006 Sep;3(3):215-23. doi: 10.1111/j.1742-481X.2006.00238.x. |
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