Effectiveness of Microcurrents Therapy in Pressure Ulcers in Elderly People
NCT ID: NCT03753581
Last Updated: 2021-06-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2018-10-31
2021-06-10
Brief Summary
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Detailed Description
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The size of the sample will be 30 participants older than 60 years old who are institutionalized in some nursing homes in Spain.They will be randomized in two groups: control or experimental.
The variables of the study will be collected at three time points: before the intervention, 14 days after the start of the intervention and at the end of the intervention.
The statistical analysis will be an intention-to-treat analysis. For the main outcomes variables a two-factor ANOVA will-be performed (intervention-time) with a post-hoc analysis with Bonferroni correction
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Masking of the participants: it will be done using the same electrodes and microcurrent devices in both groups. In the placebo stimulation, the device will emit a luminous signal of operation as well as the devices of the intervention group, however, it will be manipulated and tested with an oscilloscope to ensure that it does not emit microcurrents. The participants of both groups will not perceive any sensation of current, since the electrical stimulation with microcurrents is below the sensitive threshold.
Study Groups
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Care protocol plus microcurrents
* Standardized protocol of nursing care: postural treatment plus standardized cure.
* Intervention with microcurrents: application of 2 electrodes (Mc Patch, Newmark USA) around the ulcer.
Care protocol plus microcurrents
CARE NURSING PROTOCOL: postural treatment every 4 hours more standardized cure according to the guide of recommendations based on evidence in prevention and treatment of pressure ulcers in adults of Osakidetza health service.
MICROCURRENTS: the electrodes will be placed on the edge of the dressing on the sides of the ulcer's longer length during 12 hours a day until the ulcer is completely healed or for a maximum of 25 days.
Characteristics of microcurrents: pulsed monophasic rectangular wave with a pulse of 1.5 s and pause of 300 ms, voltage 21 mV and intensity 42μA with a current density of 4.2 μA.
Care protocol plus placebo microcurrents
* Standardized protocol of nursing care: postural treatment plus standardized cure.
* Placebo microcurrents: application of 2 electrodes (Mc Patch, Newmark USA) around the ulcer previously handled that do not emit current.
Care protocol plus placebo microcurrents
The same nursing care protocol described for the experimental group will be applied more 12 hours per day of 2 electrodes of microcurrents around the ulcer, which will be previously manipulated and tested with an oscilloscope so that they do not emit electrical currents
Interventions
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Care protocol plus microcurrents
CARE NURSING PROTOCOL: postural treatment every 4 hours more standardized cure according to the guide of recommendations based on evidence in prevention and treatment of pressure ulcers in adults of Osakidetza health service.
MICROCURRENTS: the electrodes will be placed on the edge of the dressing on the sides of the ulcer's longer length during 12 hours a day until the ulcer is completely healed or for a maximum of 25 days.
Characteristics of microcurrents: pulsed monophasic rectangular wave with a pulse of 1.5 s and pause of 300 ms, voltage 21 mV and intensity 42μA with a current density of 4.2 μA.
Care protocol plus placebo microcurrents
The same nursing care protocol described for the experimental group will be applied more 12 hours per day of 2 electrodes of microcurrents around the ulcer, which will be previously manipulated and tested with an oscilloscope so that they do not emit electrical currents
Eligibility Criteria
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Inclusion Criteria
* Participants presenting pressure ulcers in phase II, III and IV according to the North American National Pressure Ulcer Advisory Panel System and the European Pressure Ulcer Advisory Panel System.
* Time of evolution of the pressure ulcer greater than 1 month and less than 24 months.
* Ulcer size greater than 1 cm2.
* Less than 14 points on the Braden scale.
Exclusion Criteria
* Metal implants in the pressure ulcer area.
* Pressure ulcer in occipital area.
* Cancer.
* Osteomyelitis.
* 3 or more abnormal blood values at the beginning of the study that indicate a limited healing potential (anemia, iron deficiency, protein deficiency, dehydration, uncontrolled diabetes or hypothyroidism)
* Allergies to the usual cures protocol established.
* Systemic infection
* Recent history (minimum of 30 days) of treatment with growth factors or vacuum-assisted treatment.
60 Years
ALL
No
Sponsors
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Residencia Geriátrica San Diego, S.L.
UNKNOWN
Residencia de Mayores Río Tajo ARTEVIDA. Centro Serviger Talavera
UNKNOWN
University of Castilla-La Mancha
OTHER
Responsible Party
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Principal Investigators
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Juan Avendaño Coy, PhD
Role: STUDY_DIRECTOR
University of Castilla-La Mancha
Locations
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Juan Avendaño-Coy
Toledo, , Spain
Countries
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Other Identifiers
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EUEYF
Identifier Type: -
Identifier Source: org_study_id
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