None listed
Conditions
Brief summary
Clinical practice guidelines in Europe, the United States, and Canada recommend applying (ES) to chronic PUs resistant to standard wound care (SWC). However, the exact rules for applying ES to different-Category 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. 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. The authors of in vivo experiments with animals concluded that anodal ES was appropriate as a means of improving the healing of acute skin wounds, because it caused the wound surface to close and the wound potential to return faster to the preinjury level. Borba’s randomized in vivo study with rats showed that anodal ES improved neoangiogenesis in the early stage of acute experimental wound healing. 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. Our experiment aims to expand the knowledge of how HVMPC delivered by, respectively, the cathode and the anode as the treatment electrodes contributes to the healing of Category II - IV PUs in people with spinal cord injury at high risk of PU development. In the experiment, cathodal and anodal HVPC will be applied to treat PUs and will be compared for effectiveness. Our study is specifically designed to test the following hypotheses: 1. Both cathodal and anodal HVMPC administrated as part of an interdisciplinary wound care programme improve the healing of Category II-IV PUs. 2. Cathodal HVMPC increases periwound skin blond flow and accelerates the healing of PUs more than anodal HVMPC does. Another purpose of the experiment is gain new knowledge about the efficacy of cathodal and anodal HVMPC in wound healing
Interventions
Aim of study
The purpose of this prospective, parallel-group, randomized, double-blind, controlled, clinical trial is to compare the skin blood flow and healing progress of pressure ulcers (PU) in people with spinal cord injury after 8 weeks of intervention involving standard wound care (SWC), SWC in conjunction with high voltage monophasic pulsed current (HVMPC) delivered by the cathode, and SWC combined with HVMPC delivered by the anode as the treatment electrodes.
Demographic information o
Aim of study The purpose of this prospective, parallel-group, randomized, double-blind, controlled, clinical trial is to compare the skin blood flow and healing progress of pressure ulcers (PU) in people with spinal cord injury after 8 weeks of intervention involving standard wound care (SWC), SWC in conjunction with high voltage monophasic pulsed current (HVMPC) delivered by the cathode, and SWC combined with HVMPC delivered by the anode as the treatment electrodes. Demographic information on the patients will be compiled during standardized interviews and physical examinations, as well as from additional examinations of the patients 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 Pressure Ulcer Advisory Panel criteria: Category II ulcers = partial-thickness loss of the dermis presenting as a shallow open ulcer with a red pink wound bed, without slough; Category III ulcers = full-thickness tissue loss; subcutaneous fat may be visible but bone, tendon or muscle are not exposed; Category IV ulcers = full-thickness tissue loss with exposed tendon, muscle or bone. Slough or eschar may be present on some parts of the wound bed. Can include undermining and tunnelling. SWC programme administered to all groups. All patients will be treated to prevent the development of new PUs. Pressure-redistribution surfaces, devices and pillows will be applied as needed. A nurse or physiotherapist 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 ES group, patients will be administered HVMPC in addition to SWC. The device for applying HVMPC will be the Intelect Advanced Combo (by Chattanooga, USA). The device generates a twin-peak monophasic pulse consisting of two 77- microsecond 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 0.25-0.40 A, so patients will only experience sensory effects (without motor reactions). Voltage will be set to 100 – 120 V. and the electrodes will deliver an electrical charge of 250- 500 microcoulomb per second. This HVMPC protocol has been selected because of the positive results of earlier clinical trials on patients with 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 at least 20 cm from the PU. Before and after each ES procedure, the electrodes will be sterilized in a disinfectant solution. Over the period of the intervention, the negative electrode (cathode) will be used to treat PUs. 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. PUs will be thoroughly cleansed with a 0.9% sodium chloride solution and covered with the earlier described dressings immediately after ES the procedure. Electrical stimulation with the anode Patients in the anodal ES group will receive HVMPC in the same way as patients in the cathodal ES group, but the treatment electrode will be the anode. The authors of other clinical studies on PUs used anodal stimulation. HVMPC with the cathode (in the cathode ES group) and with the anode (in the anode ES group) will be applied for a period of 8 weeks (total of 40 HVPC sessions), during which wounds will be observed for healing progress.
Sponsors
Academy of Physical Education
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patient eligibility for the experiment will be established by their physician as per the following criteria: a) spinal cord injury (SCI); b) brain injury (caused by stroke or mechanical injury); c) older than 18 years of age; d) hospitalized in a rehabilitation center; e) with Category II, III or IV PU of at least 0.5 cm2 in size and of duration of at least 4 weeks.
Exclusion criteria
The patients who are not qualify for ES (cancer, electronic implants, malignant, tunneling and necrotic wounds, osteomyelitis, PU requiring surgical intervention) will be excluded from participating, as well as those with diagnoses that might interfere with wound healing, such as diabetes (HbA1C > 7%), venous insufficiency, critical infection.
Outcome results
None listed