Influence of low voltage monophasic pulsed current and low voltage biphasic pulsed current on pressure ulcer healing based on clinical treatment effects and basic research.

• Register: ANZCTR
• Last refreshed on: 11 June 2018
• Main ID: ACTRN12618000345280
• Date of registration: 07/03/2018
• Prospective Registration: Yes
• Primary sponsor: Academy of Physical Education
• Public title: Influence of low voltage monophasic pulsed current and low voltage biphasic pulsed current on pressure ulcer healing based on clinical treatment effects and basic research.
• Scientific title: A comparison of the efficacy of monophasic pulsed current and biphasic pulsed current in the treatment of Stage II-IV pressure ulcers. A prospective, randomized, controlled, clinical study.
• Date of first enrolment: 26/03/2018
• Target sample size: 72
• Recruitment status: Recruiting
• URL: http://www.anzctr.org.au/ACTRN12618000345280.aspx
• Study type: Interventional
• Study design: Randomised controlled trial Parallel
• Phase: Not Applicable

Health Condition(s) or Problem(s) studied

Wound healing

Chronic wound healing

Pressure ulcer healing

Pressure ulcer

Chronic wound

Intervention(s)

Aim of study
The purpose of this prospective, parallel-group, randomized, blinded, controlled, clinical trial is to compare the healing progress of Stage II-IV pressure ulcers (PU) in adult persons after 8 weeks of intervention involving standard wound care (SWC) plus sham electrical stimulation (ES), SWC in conjunction with low voltage monophasic pulsed current (LVMPC), and SWC in conjunction with low voltage biphasic pulsed current (LVBPC).

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: 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 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 the 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 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 LVMPC
In the LVMPC group, patients will be administered LVMPC 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 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 (60 cm2) will be placed on an aseptic gauze pad saturated with physiological saline overlaying the wound site. The dispersive electrode (60 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. Pressure ulcers will be stimulated with both cathode and anode. The polarization of the treatment electrode will be changed weekly, with treatment beginning with cathodal stimulation.

Electrical stimulation with LVBPC
In the LVBPC group, patients will be administered LVBPC in addition to SWC. The device for applying LVBPC will be the TrioStim 215 (by Mettler Electronics, USA) generating a rectangular, biphasic pulses with duration of 100 microseconds and frequency of 100 pps. A current of 36 mA 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 (60 cm2) will be placed on an aseptic gauze pad saturated with physiological saline overlaying the wound site. The dispersive electrode (60 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. .

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