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

Pressure Ulcer Clinical Trial

— POTER-OIL  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05144646
• Other study ID #: PI21/01197
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 4, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2021
• Source: University of Malaga
• Contact: Inmaculada Lupiáñez Pérez, PhD
• Phone: 651563914
• Email: inmalupianez[@]uma.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 46
• Est. completion date: December 31, 2024
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

PHASE ONE HEALTHY SUBJECTS

Inclusion criteria:

• Healthy volunteers, aged > 20 years without functional limitation.

• BMI of 18.5-25.9 kg/cm2.

• No scars on the heels.

Exclusion criteria:

• Failure to meet all of the above criteria.

• Smokers.

• Consume high levels of alcohol (> 20g/week).

• Tattoos in the measurement areas.

PHASE TWO - PATIENTS

Inclusion criteria:

• Patients aged > 20.

• Patients with risk of deterioration of skin integrity according to Braden score <16.

• no presence of Press Ulcer.

Exclusion criteria:

• Presence of vasoactive drugs in infusion

• Subjects with a pacemaker and/or implanted defibrillator.

• Fever and anaemia with Hb <10 g/dl.

• Hypotension with systolic blood pressure <80 mmHg.

• Transfusion during the last four weeks.

Related Conditions & MeSH terms

• Pressure Ulcer

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
JOSE MIGUEL MORALES ASENCIO

References & Publications (25)

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. — View Citation

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. — View Citation

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. Review. — View Citation

Díaz-Valenzuela A, García-Fernández FP, Carmona Fernández P, Valle Cañete MJ, Pancorbo-Hidalgo PL. Effectiveness and safety of olive oil preparation for topical use in pressure ulcer prevention: Multicentre, controlled, randomised, and double-blinded clinical trial. Int Wound J. 2019 Dec;16(6):1314-1322. doi: 10.1111/iwj.13191. Epub 2019 Sep 2. — View Citation

Ferris A, Price A, Harding K. Pressure ulcers in patients receiving palliative care: A systematic review. Palliat Med. 2019 Jul;33(7):770-782. doi: 10.1177/0269216319846023. Epub 2019 Apr 24. Erratum in: Palliat Med. 2020 Jul;34(7):969. — View Citation

Gallart, E., Fuentelsaz, C., Vivas, G., Garnacho, I., Font, L., & Arán, R. (2001). Estudio experimental para comprobar la efectividad de los ácidos grasos hiperoxigenados en la prevención de las úlceras por presión en pacientes ingresados. Enfermería Clínica, 11(5), 179-183. https://doi.org/10.1016/s1130-8621(01)73714-x

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. — View Citation

Gómez-González AJ, Morilla-Herrera JC, Lupiáñez-Pérez I, Morales-Asencio JM, García-Mayor S, León-Campos Á, Marfil-Gómez R, Aranda-Gallardo M, Moya-Suárez 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. — View Citation

Jull A, McCall E, Chappell M, Tobin S. Measuring hospital-acquired pressure injuries: A surveillance programme for monitoring performance improvement and estimating annual prevalence. Int J Nurs Stud. 2016 Jun;58:71-79. doi: 10.1016/j.ijnurstu.2016.02.005. Epub 2016 Feb 17. — View Citation

Lázaro-Martínez JL, López-Moral M, García-Alamino JM, Bohbot S, Sanz-Corbalán I, García-Álvarez Y. Evolution of the TcPO(2) values following hyperoxygenated fatty acids emulsion application in patients with diabetic foot disease: results of a clinical trial. J Wound Care. 2021 Jan 2;30(1):74-79. doi: 10.12968/jowc.2021.30.1.74. — View Citation

Lechner A, Kottner J, Coleman S, Muir D, Beeckman D, Chaboyer W, Cuddigan J, Moore Z, Rutherford C, Schmitt J, Nixon J, Balzer K. Outcomes for Pressure Ulcer Trials (OUTPUTs) project: review and classification of outcomes reported in pressure ulcer prevention research. Br J Dermatol. 2021 Apr;184(4):617-626. doi: 10.1111/bjd.19304. Epub 2020 Jul 27. Review. — View Citation

Li Z, Lin F, Thalib L, Chaboyer W. Global prevalence and incidence of pressure injuries in hospitalised adult patients: A systematic review and meta-analysis. Int J Nurs Stud. 2020 May;105:103546. doi: 10.1016/j.ijnurstu.2020.103546. Epub 2020 Jan 31. — View Citation

Lindgren M, Malmqvist LA, Sjöberg 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. — View Citation

Lovegrove J, Fulbrook P, Miles S, Steele M. Effectiveness of interventions to prevent pressure injury in adults admitted to intensive care settings: A systematic review and meta-analysis of randomised controlled trials. Aust Crit Care. 2021 Jun 15. pii: S1036-7314(21)00063-1. doi: 10.1016/j.aucc.2021.04.007. [Epub ahead of print] Review. — View Citation

Lovegrove J, Fulbrook P, Miles SJ, Steele M. Effectiveness of interventions to prevent pressure injury in adults admitted to acute hospital settings: A systematic review and meta-analysis of randomised controlled trials. Int J Nurs Stud. 2021 Oct;122:104027. doi: 10.1016/j.ijnurstu.2021.104027. Epub 2021 Jun 30. Review. — View Citation

Lupiañez-Pérez I, Morilla-Herrera JC, Kaknani-Uttumchandani S, Lupiañez-Perez Y, Cuevas-Fernandez-Gallego M, Martin-Santos F, Caro-Bautista J, Morales-Asencio JM. A cost minimization analysis of olive oil vs. hyperoxygenated fatty acid treatment for the prevention of pressure ulcers in primary healthcare: A randomized controlled trial. Wound Repair Regen. 2017 Sep;25(5):846-851. doi: 10.1111/wrr.12586. Epub 2017 Nov 6. — View Citation

Lupiañez-Perez I, Uttumchandani SK, Morilla-Herrera JC, Martin-Santos FJ, Fernandez-Gallego MC, Navarro-Moya FJ, Lupiañez-Perez Y, Contreras-Fernandez E, Morales-Asencio JM. Topical olive oil is not inferior to hyperoxygenated fatty aids to prevent pressure ulcers in high-risk immobilised patients in home care. Results of a multicentre randomised triple-blind controlled non-inferiority trial. PLoS One. 2015 Apr 17;10(4):e0122238. doi: 10.1371/journal.pone.0122238. eCollection 2015. — View Citation

Mäki-Turja-Rostedt S, Stolt M, Leino-Kilpi H, Haavisto E. Preventive interventions for pressure ulcers in long-term older people care facilities: A systematic review. J Clin Nurs. 2019 Jul;28(13-14):2420-2442. doi: 10.1111/jocn.14767. Epub 2019 Jan 25. — View Citation

Pancorbo Hidalgo, P. L., García Fernández, F. P., Pérez López, C., & Soldevilla Agreda, J. J. (2019). Prevalencia de lesiones por presión y otras lesiones cutáneas relacionadas con la dependencia en población adulta en hospitales españoles: resultados del 5o Estudio Nacional de 2017. Gerokomos, 30(2), 76-86. http://www.scielo.org.co/scielo.php?script=sci_arttext&pid=S2011-08392020000400014&lang=es%0Ahttp://www.scielo.org.co/pdf/unmed/v61n4/2011-0839-unmed-61-04-00014.pdf

Pittman J, Beeson T, Dillon J, Yang Z, Cuddigan J. Hospital-Acquired Pressure Injuries in Critical and Progressive Care: Avoidable Versus Unavoidable. Am J Crit Care. 2019 Sep;28(5):338-350. doi: 10.4037/ajcc2019264. — View Citation

Shi C, Dumville JC, Cullum N. Skin status for predicting pressure ulcer development: A systematic review and meta-analyses. Int J Nurs Stud. 2018 Nov;87:14-25. doi: 10.1016/j.ijnurstu.2018.07.003. Epub 2018 Jul 8. — View Citation

Tisserand G, Zenati N, Seinturier C, Blaise S, Pernod G. Prevalence and severity of peripheral arterial disease among patient with heel pressure ulcer: a retrospective study of 42 patients. Geriatr Psychol Neuropsychiatr Vieil. 2017 Sep 1;15(3):242-246. doi: 10.1684/pnv.2017.0680. — View Citation

Torra-Bou, J. E., Pérez-Acevedo, G., Bosch-Alcaraz, A., García-Fernández, F. P., Sarabia-Lavin, R., Soldevilla-Agreda, J. J., & Verdú-Soriano, J. (2020). Pressure injury incidence in pediatric and neonatal intensive care units: Systematic review (2000-2016). Gerokomos, 31(3), 180-192. https://doi.org/10.4321/S1134-928X2020000300010

Torra-Bou, J.-E., García-Fernández, F.-P., Pérez-Acevedo, G., Sarabia-Lavin, R., Paras-Bravo, P., Rodríguez-Palma, M., & Verdú-Soriano, J. (2017). El impacto económico de las lesiones por presión. Revisión bibliográfica integrativa. Gerokomos (Madr., Ed. Impr.), 28(2), 83-87. https://scielo.isciii.es/scielo.php?script=sci_arttext&pid=S1134-928X2017000200083

VanGilder C, Lachenbruch C, Algrim-Boyle C, Meyer S. The International Pressure Ulcer Prevalence™ Survey: 2006-2015: A 10-Year Pressure Injury Prevalence and Demographic Trend Analysis by Care Setting. J Wound Ostomy Continence Nurs. 2017 Jan/Feb;44(1):20-28. doi: 10.1097/WON.0000000000000292. — View Citation

* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.