Effectiveness Study of Electrical Stimulation in Prevention of Decubitus.

Background of the study:

Decubitus ulcers represent a major burden of sickness and reduced quality of life for patients and their carers. In general hospital Medisch Spectrum Twente, Holland, the incidence of decubitus developed on the Intensive Care was 123 patients in the year 2008 (18%). There have been several studies that showed a possible positive effect of electrical stimulation on wound healing. One of the working principles is increasing blood flow. This could mean that by giving frequent electrical stimulation on the foot and lower leg, the blood flow increases and thereby the amount of oxygen to the skin. Our hypothesis is that this will help to reduce the risk of decubitus on the heel.


Objective of the study:

The primary objective of this study is to investigate the effectiveness of electrical stimulation in reducing the incidence of decubitus ulcers on the heel in Intensive Care patients.


Study design:

The study design is a prospective, within patients randomised controled pilot study with randomisation between both legs of the patient. The socks will be worn on both feet but only one foot will get electrical stimulation.


Study population:

Patients who are admitted to the Intensive Care ward of Medisch Spectrum Twente and are likely to stay there for at least 48 hours.


Intervention:

The treatment group (one leg of the patient) will get electrical stimulation for 1 hour a day. The control group ( the other leg of the patient) will wear the sock, but will not get the electrical stimulation.


Primary study parameters/outcome of the study:

Main study parameter/endpoint is the incidence of decubitus on the heel in participating patients and the difference in incidence of decubitus between treatment and control leg.

There have been several studies that showed a possible positive effect of electrical stimulation on wound healing. One of the working principles is increasing blood flow. This could mean that by giving frequent electrical stimulation on the foot and lower leg, the blood flow increases and thereby the amount of oxygen to the skin. Our hypothesis is that this will help to reduce the risk of decubitus on the heel.

Patients will be treated during their stay on the ICU or until a pressure ulcer of grade 1 or higher occurs.

The patients will wear a sock on each foot that contains electrodes for electrical stimulation. For each patients it will be randomised which foot receives electrical stimulation for one hour per day. The treatment stops when a pressure ulcer of grade 1 or higher occurs or when the patient is discharged from the Intensive Care.

Details of the electrical stimulation:

1. Frequency: 100 Hz;

2. Pulse width 200 milliseconds;

3. Output current 6 mA.