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Prospective observational risk-analysis of the incidence and severity of pressure ulcers and wound infections in obese patients in the ICU.


- candidate number14057
- NTR NumberNTR3736
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-dec-2012
- Secondary IDsMETC nr. 1325 NL 44404.008.13 
- Public TitleProspective observational risk-analysis of the incidence and severity of pressure ulcers and wound infections in obese patients in the ICU.
- Scientific TitleProspective observational risk-analysis of the incidence and severity of pressure ulcers and wound infections in obese patients in the ICU.
- ACRONYM
- hypothesisPatients with a BMI > 30 kg/m2 in the ICU have a higher incidence of pressure ulcers and wound infections in the ICU compared with patients with a BMI 18-25kg/m2. They develop them sooner during admittance and the severity and time to recovery are higher in the patients with obesity.
- Healt Condition(s) or Problem(s) studiedObesity, Intensive care, Pressure ulcers, Wound infection
- Inclusion criteria1. Every patient admitted to the ICU;
2. Age > 16 years;
3. Length of stay in the ICU > 3 days;
4. Known length and weight < 72 hours after admission.
- Exclusion criteria1. Age < 16 years;
2. Expected death (infauste prognose) known within 3 days after admission;
3. Loss of a limb prior to admission.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 21-mei-2013
- planned closingdate1-jun-2016
- Target number of participants1175
- InterventionsN/A
- Primary outcome1. Incidence of pressure ulcer and wound infection;
2. Time to development of pressure ulcer or wound infection;
3. Severity of pressure ulcer and wound infection;
4. Time to heal of pressure ulcer and wound infection.
- Secondary outcome1. Length of stay in the ICU;
2. Length of name in the hospital.
- TimepointsFollow-up until healing of the ulcer or wound, discharge from the hospital or death.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES A. Olffen, van
- CONTACT for SCIENTIFIC QUERIES A. Olffen, van
- Sponsor/Initiator St. Elisabeth Hospital, Tilburg
- Funding
(Source(s) of Monetary or Material Support)
St. Elisabeth Hospital, Tilburg
- PublicationsN/A
- Brief summarySingle centre, observational study to test the hypothesis that obesity atrributes to the risk for development of pressure ulcers and wound infections in the ICU. The effect of obesity on the time to development of awound infection or pressure ulcer, the severity and time to recovery is assessed. The known risk factors are registered to analyse the specific effect on the hypothesis.
- Main changes (audit trail)
- RECORD4-dec-2012 - 24-apr-2014


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