Clinical trial NCT05144646: Peripheral Tissue Perfusion and Oxygenation in Areas at Risk of Press Ulcer (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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pressure Ulcer
Keywords: Hyperoxygenated fatty acid
Olive oil
Prevention
Perfusion and Oxygenation
Lead sponsor: University of Malaga
Sponsor class: OTHER
First posted: 2021-12-03
Enrollment: 46
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Perfusion and tissue temperature
timeFrame: 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.
measure: Tissue oxygenation
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Faculty of Health Sciences, University of Málaga, Spain
name: Inmaculada Lupiáñez Pérez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
citation: Diaz-Valenzuela A, Garcia-Fernandez FP, Carmona Fernandez P, Valle Canete 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.
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.
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
citation: 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.
citation: 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.
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.
citation: Lazaro-Martinez JL, Lopez-Moral M, Garcia-Alamino JM, Bohbot S, Sanz-Corbalan I, Garcia-Alvarez Y. Evolution of the TcPO2 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.
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.
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.
citation: 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.
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.
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. 2022 Mar;35(2):186-203. doi: 10.1016/j.aucc.2021.04.007. Epub 2021 Jun 16.
citation: Lupianez-Perez I, Morilla-Herrera JC, Kaknani-Uttumchandani S, Lupianez-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.
citation: Lupianez-Perez I, Uttumchandani SK, Morilla-Herrera JC, Martin-Santos FJ, Fernandez-Gallego MC, Navarro-Moya FJ, Lupianez-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.
citation: Maki-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.
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
citation: 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.
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.
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.
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
citation: 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
citation: 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.