None listed
Conditions
Brief summary
Clinical practice guidelines in Europe, the United States, and Canada recommend applying electrical stimulation (ES) to chronic pressure ulcers resistant to standard wound care (SWC). However, the exact rules for applying ES to different-stage wounds are still to be developed and tested in clinical studies. It is though that the polarity of the treatment electrode used during ES procedures is significance for the healing process. Despite the specific rules for treating human wounds with the anode and the cathode not having been developed yet, the results of in vitro and in vivo studies indicate that both these electrodes can promote wound healing and that the polarity of the treatment electrode should match the wound healing stage. Clinical studies differ in which electrode is used as the treatment electrode. Some authors stimulate wounds with the anode and reverse polarity to negative only if healing progress is not satisfactory. In other studies, the cathode is applied for the length of treatment or for the first 1-3 weeks after which polarity is reversed every week or the anode is introduced for the remainder of treatment. According to the authors of in vitro studies, cells involved in tissue repair migrate toward the electric field created by the anode or the cathode. In cell cultures, the anode enhances the motility of macrophages and neutrophils, but human keratinocytes, fibroblasts and bovine corneal epithelial cells migrate directionally toward the cathode. The results of in vitro studies suggest that anodal stimulation is appropriate for increasing macrophage and phagocyte activity during the wound’s inflammatory phase, whereas cathodal stimulation can be effective in the proliferative phase of the wound healing process. However, the results of in vivo experiments with animals are not consistent. A series of studies in vivo studies with rabbits carried out in the years 1987-1995 suggests that in the initial phases of treatment negative-polarity ES should be administered (mainly to stimulate the granulation tissue formation) and positive-polarity ES afterwards to encourage wound re-epithelization. On the other hand, studies conducted in the 1990s and in the first decade of the 2000’s showed anodal stimulation to have a positive effect in the inflammatory phase of new wounds and the cathode to be effective in stimulating granulation tissue formation and re-epithelization processes. More experiments are necessary to develop clear rules on how wounds should be treated with the cathode and anode. Our experiment aims to expand the knowledge of how HVPC delivered by, respectively, the cathode and the anode as the treatment electrodes contributes to the healing of stage II - IV pressure ulcers in geriatric people at high risk of PU development. In the experiment, cathodal and anodal HVPC will be applied to treat pressure ulcers and will be compared for effectiveness. Our study is specifically designed to test the following hypotheses: 1. Both cathodal and cathodal/anodal HVPC administrated as part of an interdisciplinary wound care program improve the healing of stage II - IV pressure ulcers 2. Pressure ulcers stimulated by cathodal HVPC for six weeks heal faster than PUs receiving only SWC and PUs receiving cathodal stimulation in the first week of treatment and anodal stimulation for the remaining 5 weeks . Another purpose of the experiment is gain new knowledge about the efficacy of HVPC.
Interventions
Aim of study
The purpose of this prospective, parallel-group, randomized, controlled, clinical trial is to compare the healing progress of pressure ulcers (PU) in geriatric people after 6 weeks of intervention involving standard wound care (SWC), SWC in conjunction with high voltage pulsed current (HVPC) delivered by the cathode, and SWC combined with HVPC delivered by the cathode and the anode as the treatment electrodes.
Demographic information on the subjects will be compiled during stan
Aim of study The purpose of this prospective, parallel-group, randomized, controlled, clinical trial is to compare the healing progress of pressure ulcers (PU) in geriatric people after 6 weeks of intervention involving standard wound care (SWC), SWC in conjunction with high voltage pulsed current (HVPC) delivered by the cathode, and SWC combined with HVPC delivered by the cathode and the anode as the treatment electrodes. Demographic information on the subjects will be compiled during standardized interviews and physical examinations, as well as from additional examinations of the subjects and the documentation of their concomitant diseases. The patients’ physical and mental conditions, activity, mobility and incontinence will be assessed using the Norton scale (a score < 14 indicated a high risk of PU development). To assess the possibility of friction and shear and wound moisture, as well as sensory perception of the patients, their physical activity and mobility the Braden Scale will be applied (a score < 16 pointed to a high risk of PU development). Patients’ nutritional status will be identified by means of the Nutritional Risk Score (NRS-2002). Wound severity at enrolment will be assessed based on the National and European Pressure Ulcer Advisory Panel criteria: Stage II ulcers = partial-thickness loss of the dermis presenting as a shallow open ulcer with a red pink wound bed, without slough; Stage III ulcers = full-thickness tissue loss; subcutaneous fat may be visible but bone, tendon or muscle are not exposed; Stage IV ulcers = full-thickness tissue loss with eposed tendom, muscle or bone. Slough or eschar may be present on some parts of the wound bed. Can include unermining and tunneling. SWC programme administered to all groups. All patients will be treated to prevent the development of new pressure ulcers. Pressure-redistribution surfaces, devices and pillows will be applied as needed. A nurse will reposition the immobile patients every 2 hours at the least. Blood tests will be carried out to screen for nutritional status markers and metabolic disorders such as anaemia (iron deficiency anaemia or anaemia of chronic disease), thyroid dysfunction, impaired glycaemic control, dehydration, protein deficit, hypoalbuminemia. Wounds will be regularly assessed by the attending physician over the period of the study to select topical treatments appropriately addressing moisture control, bacterial burden, and debridement needs; microbiological culture and sensitivity tests will also be performed. A team formed of a physician, a nurse, a physical therapist and a dietician will make comprehensive, interdisciplinary assessments of the patients to develop SWC programmes meeting their specific demands, for instance consisting of nutritional intervention, optimization of the wound dressing protocol, and incontinence management. The clinician caregivers will be blinded to participant’s group. Patients in all groups will receive similar standard topical care, selected to address their individual needs and to promote moist interactive healing. All immobilized patients will receive low-molecular-weight heparin (enoxaparin) as a standard therapy. Patients with elevated leukocyte levels will be treated with antibiotics selected following microbiological culture and sensitivity testing of the PU swab. Electrical stimulation with the cathode In the cathode HVPC group, patients will be administered HVPC in addition to SWC. The device for applying HVPC will be the Intelect Advanced Combo (by Chattanooga, USA). The device generates a twin-peak monophasic pulse consisting of two 77- microseconds exponential pulses in rapid succession (the twin-peak pulse duration was 154 microseconds). Pulse frequency will be 100 pps. Current intensity will be set within 0.25-0.30 A, so patients will only experience sensory effects (without motor reactions). Voltage will be set to 100 V and the electrodes will deliver an electrical charge of 250 microcoulomb per second. This HVPC protocol has been selected because of the positive results of earlier clinical trials on patients with pressure ulcers (Pus) and venous leg ulcers (VLUs). Each patient will have their own set of electrodes made of conductive carbon rubber. The treatment electrode (of a size matching the wound surface area) will be placed on an aseptic gauze pad saturated with physiological saline overlaying the wound site. The dispersive electrode (bigger than the treatment electrode) closing the electrical circuit will be positioned about 20 cm from the PU (proximally or distally, depending on where the PU developed). Over the period of the intervention, the negative electrode (cathode) will be used to treat pressure ulcers. The authors of some other clinical studies on PUs have also used cathodal stimulations. In the experiment, five 50-minute sessions will be held per week (one a day), following the approach adopted by other authors. Pressure ulcers receiving SWC and cathode HVPC will be monitored for healing progress for 6 weeks or until wounds close, whichever occurs first. Electrical stimulation with the cathode and the anode Patients in the cathode/anode HVPC group will receive HVPC in the same way as patients in the cathode HVPC group, but first the cathode will be applied as the treatment electrode to stimulate the growth of granulation tissue. Cathodal stimulation will be used in week 1 (5 days) and then it will be replaced by anodal stimulation for the remainder of the experiment. The authors of other clinical studies on VLUs and PUs used the same sequence of cathodal and anodal stimulation. Before and after each ES procedure, the electrodes will be sterilized in a disinfectant solution. Pressure ulcers will be thoroughly cleansed with a 0.9% sodium chloride solution and covered with the earlier described dressings immediately after the procedure. Pressure ulcers receiving SWC and cathode/anode HVPC will be monitored for healing progress for 6 weeks or until wounds close, whichever occurs first.
Sponsors
Academy of Physical Education,
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patient eligibility for the experiment will be established by their physician according to the following criteria: older than 60 years of age, at high risk of PU development (a score on the Norton scale below 14 points), with a stage II, III or IV pressure ulcer of at least 0.5 cm2 in size and of minimal duration 4 weeks.
Exclusion criteria
Any condition that might prevent the application of electrical stimulation (ES) (a cardiac pacemaker, cancer, osteomyelitis, PU in need of surgical intervention).
Outcome results
None listed