The 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.
ID
Bron
Verkorte titel
Aandoening
pelvic fracture, circumferential compression device, pressure sores, bekkenfractuur, bekkenbinder, decubitus risico
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Exerted pressure (distribution) on the skin (kPa)
Achtergrond van het onderzoek
The 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.
Doel van het onderzoek
The 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.
Onderzoeksopzet
T=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
Onderzoeksproduct en/of interventie
A 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.
Publiek
S.P. Knops
Researcher dept. of Surgery-Traumatology
(Room H-974)
's-Gravendijkwal 230, 3015 CE Rotterdam
Rotterdam 3000 CA
The Netherlands
+31-10 70 32419
s.knops@erasmusmc.nl
Wetenschappelijk
S.P. Knops
Researcher dept. of Surgery-Traumatology
(Room H-974)
's-Gravendijkwal 230, 3015 CE Rotterdam
Rotterdam 3000 CA
The Netherlands
+31-10 70 32419
s.knops@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Volunteers between 18 and 70 years of age;
2. Blank medical history;
3. Signed informed consent.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. (History of) pelvic or low-back complaints;
2. Pelvic fractures;
3. Skin problems in the pelvic region;
4. Pregnancy
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL1169 |
NTR-old | NTR1214 |
Ander register | METC Erasmus MC : MEC-2007-278 |
ISRCTN | ISRCTN wordt niet meer aangevraagd |
Samenvatting resultaten
Schipper IB. Randomised clinical trial comparing pressure characteristics
of pelvic circumferential compression devices in healthy volunteers.
Injury 2011;42(10):1020-1026.