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Risk of developing pressure sores by non-invasive pelvic circumferential compression devices.


- candidate number3106
- NTR NumberNTR1214
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-mrt-2008
- Secondary IDsMEC-2007-278 METC Erasmus MC
- Public TitleRisk of developing pressure sores by non-invasive pelvic circumferential compression devices.
- Scientific TitleThe exerted pressure as a measure of the risk of developing pressure sores by pelvic circumferential compression devices; a crossover study.
- ACRONYMN/A
- hypothesisThe exerted pressure on the skin by non-invasive pelvic circumferential compression devices (PCCDs) carries a risk of pressure sores and skin necrosis in case of prolonged use. A persons Body Mass Index (BMI) is of influence on this risk.
- Healt Condition(s) or Problem(s) studiedPressure ulcers, Pelvic fracture, Circumferential compression device
- Inclusion criteria1. Volunteers between 18 and 70 years of age;
2. Blank medical history;
3. Signed informed consent.
- Exclusion criteria1. (History of) pelvic or low-back complaints;
2. Pelvic fractures;
3. Skin problems in the pelvic region;
4. Pregnancy
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 8-feb-2008
- planned closingdate8-aug-2008
- Target number of participants80
- InterventionsA Force Sensing Array (FSA) pressure mapping system will be placed around the pelvis. The PCCD is positioned on top of the FSA mat, following the protocol of the supplier. Measurements will be performed in 2 settings: lying on a spine board (5 minutes) and on a hospital bed (5 minutes). All three commercialley available binders will be tested once on each subject in a cross-over design. A time frame of 30 minutes in between two measurements is sufficient to rule out carry over effects.
- Primary outcomeExerted pressure (distribution) on the skin (kPa)
- Secondary outcomeN/A
- TimepointsT=0: reference
T=1: spine board, 0 minutes
T=2: spine board, 5 minutes
T=3: hospital bed, 0 minutes
T=4: hospital bed, 5 minutes
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDr. S.P. Knops
- CONTACT for SCIENTIFIC QUERIESDr. I.B. Schipper
- Sponsor/Initiator Erasmus MC, Trauma Research Unit department of Surgery, Erasmus Medical Center, Medical Ethical Committee (METC)
- Funding
(Source(s) of Monetary or Material Support)
Fonds Nuts-Ohra
- PublicationsKnops SP, Van Lieshout EMM, Spanjersberg WR, Patka P, Schipper IB. Randomised clinical trial comparing pressure characteristics of pelvic circumferential compression devices in healthy volunteers. Injury 2011;42(10):1020-1026.
- Brief summaryThe aim of our study is to measure the skin pressure (kPa) exerted by three different commercially available PCCDs in 80 healthy volunteers. The skin pressure may represent the risk of pressure sores. Literature data indicate a relation between Body Mass Index (BMI) and decubitus risk. Therefore, a wide range of BMI will be represented in this study. The aim is to include 25-30 subjects in each of the following BMI-groups: (1) underweight, BMI<18.5; (2) normal weight, BMI 18.5-24.9; (3) overweight, BMI 25.0-29.9. A study poster has been designed to recruit volunteers. While lying on a spine board, a Force Sensing Array (FSA) (Vista Medical, Winnipeg, Canada) pressure mapping system will be placed around the pelvis. Only underwear will be allowed. This mapping system has been especially developed for the purpose of investigating pressure exerted on the skin. In random order, the PCCDs will be applied, strictly following the protocol of the suppliers. After 5 minutes, subjects will be transferred to a hospital bed to mimic the clinical situation. Measurements will be continued for another 5 minutes. To minimize biological variation a cross-over design was chosen, applying all three PCCDs to all volunteers in a randomized order. Preliminary data indicate that carry-over effects can be excluded if there is 30 minutes between two measurements.
- Main changes (audit trail)
- RECORD6-mrt-2008 - 16-jan-2012


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