None listed
Conditions
Brief summary
Clinical practice guidelines in Europe, the United States, and Canada recommend applying (ES) to PU prevention and treatment. 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 di er 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 I Pus. In the experiment, cathodal and anodal PC will be applied to treat PUs and will be compared for efficacy. General purpose of the study is gain new knowledge about the efficacy of cathodal and anodal PC in wound healing. Our study is specifically designed to test the following hypotheses: 1. Both cathodal and anodal MPC administrated as part of an interdisciplinary wound care programme improve the healing of Category I PUs. 2. Both cathodal and anodal MPC change periwound skin blood flow and accelerate the healing of PUs to the same degree.
Interventions
The purpose of this pilot, parallel-group, randomized, blinded, controlled clinical trial is to compare the healing progress of category I pressure ulcers (PUs) in adult people after minimum of 2 weeks of intervention involving standard wound care (SWC), SWC in conjunction with monophasic pulsed current (MPC) delivered by the cathode, and SWC combined with MPC delivered by the anode as the treatment electrodes.
Demographic information on the patients will be compiled during standardized intervi
The purpose of this pilot, parallel-group, randomized, blinded, controlled clinical trial is to compare the healing progress of category I pressure ulcers (PUs) in adult people after minimum of 2 weeks of intervention involving standard wound care (SWC), SWC in conjunction with monophasic pulsed current (MPC) delivered by the cathode, and SWC combined with MPC 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. To assess the possibility of friction, shear, skin moisture, sensory perception of the patients, their physical activity and mobility as well as accompanying diseases affecting the progress of wound healing the Braden and Waterloo Scales will be applied. 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 I pressure ulcers = intact skin with non-blanchable redness of a localized area usually over a bony prominence. The area may be painful, firm, soft, warmer or cooler as compared to adjacent tissue. SWC programme administered to both experimental 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 or 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. All immobilized patients will receive low-molecular-weight heparin (enoxaparin) as a standard therapy. Electrical stimulation with the cathode In the cathodal ES group, patients will be administered MPC in addition to SWC. The device for applying MPC will be the Intelect Advanced Combo (by Chattanooga, USA) generating a rectangular, monophasic pulses with duration of 100 microseconds and frequency of 100 pps. A current of 36 mA (0.72 mA / cm2) will be set, which allows applying 360 microcoulomb per second to tissues. Each patient will have their own set of electrodes made of conductive carbon rubber. The treatment electrode (50 cm2) will be placed on an aseptic gauze pad saturated with physiological saline overlaying the wound site. The dispersive electrode (50 cm2) 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. This MPC protocol has been selected because of the positive results of earlier clinical trials on patients with PUs and venous leg ulcers. Electrical stimulation with the anode Patients in the anodal ES group will receive MPC in the same way as patients in the cathodal ES group, but the treatment electrode will be the anode. MPC with the cathode (in the cathode ES group) and with the anode (in the anode ES group) will be applied for 45 minutes a day, for a period of minimum 2 weeks (minimum 10 MPC 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 study will be established by their physician as per the following criteria: a) older than 18 years of age; b) patient hospitalized in a hospital ward; c) a Category I pressure ulcer; d) at least average risk of pressure ulcer development (Waterloo score equal to or greater than 10 points).
Exclusion criteria
The patients who are not qualify for ES (cancer, electronic implants and osteomyelitis in the pressure ulcer area) will be excluded from participating, as well as those with diagnoses that might interfere with wound healing, particularly diabetes (HbA1C greater than 7%), diabetic neuropathy, critical infection, alcoholism.
Outcome results
None listed