search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Comfort and Safety Study of Electrical Stimulation in Prevention of Decubitus.


- candidate number7864
- NTR NumberNTR2254
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR23-mrt-2010
- Secondary IDsP10-15 METC Medisch Spectrum Twente
- Public TitleComfort and Safety Study of Electrical Stimulation in Prevention of Decubitus.
- Scientific TitleComfort and Safety Study of Electrical Stimulation in Prevention of Decubitus.
- ACRONYMElectrical stimulation for decubitus prevention
- hypothesisElectrical stimulation on the foot and lower leg will increase the blood flow and thereby the amount of oxygen to the skin. Our overall hypothesis is that this will help to reduce the risk of decubitus on the heel. The specific hypothesis for this comfort and safety study is that the electrical stimulation is safe and not uncomfortable.
- Healt Condition(s) or Problem(s) studiedPressure ulcers
- Inclusion criteria1. Patients who are admitted to the vascular surgery ward (C3) of Medisch Spectrum Twente;
2. Expected stay on the vascular surgery ward for at least 3 days, excluding weekend days.
- Exclusion criteria1. Decubitus ulcer grade 1 4 on the heel;
2. Ulcer or surgical wound at the lower leg;
3. Amputation of one or both legs;
4. Inability to wear the sock;
5. Dark skin;
6. 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
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-mei-2010
- planned closingdate1-jun-2010
- Target number of participants25
- InterventionsThe patients will wear a sock on each foot that contains electrodes for electrostimulation. The right foot will be stimulated three times one hour in three days. The left foot will only wear the sock for the same amount of time.
- Primary outcomeThe primary objectives of this study are:
1. Will there be any adverse events, due to the electrical stimulation?
2. Are the sock and the electrical stimulation comfortable for the patient?
- Secondary outcomeN/A
- TimepointsThe patient will wear both socks 1 hour a day, for 3 days. The right foot will receive the electrical stimulation. The total time of wearing the sock and receiving electrical stimulation will be 3 hours for each patient.
- Trial web siteN/A
- statusinclusion stopped: follow-up
- 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. This is 18% of the total number of patients admitted on the Intensive Care, excluding the patients who have decubitus ulcers at the moment of admitting. These patients developed decubitus grade 1 4 despite all kind of precautions taken, like special mattresses, frequently turning patients to release pressure and nutritional status. The total costs of decubitus is estimated between 84.9 miljon euro and 1.9 biljon euro in Holland alone. 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. Before we can investigate this, we will do a comfort and safety study of the sock and electrical stimulation.

Objective of the study:
The primary objectives of this study are:
1. Will there be any adverse events, due to the electrical stimulation?
2. Are the sock and the electrical stimulation comfortable for the patient?

Study design:
The study design is a prospective intervention study. The socks will be worn on both feet to look at adverse events or discomfort of the sock. The right foot of the patient will get electrical stimulation to look at adverse events or discomfort of the electrical stimulation.

Study population:
Patients who are admitted to the vascular surgery ward (C3) of Medisch Spectrum Twente and are expected to be admitted for at least 3 days, excluding weekend days.

Intervention:
The patient will wear both socks 1 hour a day, for 3 days. The right foot will receive the electrical stimulation. The total time of wearing the sock and receiving electrical stimulation will be 3 hours for each patient.

Main study parameter/endpoint is the number of occurrences of any kind of discomfort or adverse event due to the sock or electrical stimulation.
- Main changes (audit trail)
- RECORD23-mrt-2010 - 10-apr-2011


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl