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Effectiveness Study of Electrical Stimulation in Prevention of Decubitus.


- candidate number7865
- NTR NumberNTR2255
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR23-mrt-2010
- Secondary IDsP10-16 METC Medisch Spectrum Twente
- Public TitleEffectiveness Study of Electrical Stimulation in Prevention of Decubitus.
- Scientific TitleEffectiveness Study of Electrical Stimulation in Prevention of Decubitus.
- ACRONYMEffectiveness of Electrical Stimulation in Decubitus
- hypothesisThere 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.
- Healt Condition(s) or Problem(s) studiedPressure ulcers
- Inclusion criteria1. Expected stay on the Intensive Care for at least 48 hours;
2. Braden score < 20.
- Exclusion criteria1. Decubitus ulcer grade 1 4 on the heel;
2. Ulcer at the lower leg;
3. Amputation of one or both legs;
4. Difference of more than 25% between both legs in the Ankle Brachial Index;
5. Systolic blood pressure at the foot > 250mmHg;
6. Inability to wear the sock;
7. Dark skin;
8. Other exclusion criteria included any of the following medical conditions for which electrical stimulation is contraindicated { Houghton PE, Campbell KE; 2001}:
A. Ventricular arrhythmia;
B. Atrial fibrillation;
C. Cardiac pacemaker;
D. History of deep radiation therapy within the local region;
E. Superficial metal ions or metal implants near the area;
F. Pregnancy.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2011
- planned closingdate31-aug-2011
- Target number of participants50
- InterventionsThe 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.
- Primary outcomeIncidence of decubitus ulcers of the heel.
- Secondary outcomeN/A
- TimepointsPatients will be treated during their stay on the ICU or until a pressure ulcer of grade 1 or higher occurs.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESProf. dr. J. Palen, van der
- CONTACT for SCIENTIFIC QUERIESProf. dr. J. Palen, van der
- Sponsor/Initiator Medisch Spectrum Twente
- Funding
(Source(s) of Monetary or Material Support)
European Union
- PublicationsN/A
- Brief summaryBackground 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.
- Main changes (audit trail)
- RECORD23-mrt-2010 - 10-apr-2011


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