The aim of this study: - To determine the amount of pressure of PCCDs on the skin. The Pelvic Binder, SAM Sling and T-POD will be compared.- To determine the influence of body mass index on the pressure characteristics of these 3 types of PCCDs.Theā¦
ID
Source
Brief title
Condition
- Fractures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Skin pressure (mmHg)
Secondary outcome
N.A.
Background summary
Pelvic fractures should be considered as potentially life-threatening
fractures. The mortility risk enhances with increasing severity of the pelvic
injury: hemodynamic unstable patients with a closed pelvic fracture have a
mortality risk of approximately 27%, whereas the mortality risk is 50% for
patients with an open pelvic fracture. Therefore, massive hemorrhaging leading
to death is an extremely serious complication for pelvic fracures. Depending on
the fracture type, this blood loss can be as high as 5 liters. Blood loss can
originate from several locations, e.g., the venous and arterial plexus and
bleeding fracture elements.
Fracture reduction and stabilization diminishes the potential space available
for blood loss, and may tamponade massive hemorrhage. Circumferential
compression of the pelvis as a means of gaining control over life-threatening
hemorrhage in unstable pelvic ring injuries has been described by several
authors, and is advocated by the Advanced Trauma Life Support (ATLS) Course. In
the past, bed sheets were used as mean to achieve acute circumferential
compression. At present, non-invasive pelvic circumferential compression
devices (PCCDs) are available. The Pelvic Binder, SAM Sling en T-POD are mainly
used. These may act as a temporary fix until surgical fixation interventions
can be initiated.
Little scientific evidence exists for effects and risks of PCCDs. There is
evidence showing that PCCD use may cause decubitus
Study objective
The aim of this study:
- To determine the amount of pressure of PCCDs on the skin. The Pelvic Binder,
SAM Sling and T-POD will be compared.
- To determine the influence of body mass index on the pressure characteristics
of these 3 types of PCCDs.
The results will gain insight into the risk of decubitus of PCCDs. There is a
risk of tissue damage after continuous, prolonged pressure of at least 9.3 kPa
(69.8 mmHg) on the skin during 2-3 hours.
Study design
To mimic the clinical situation as closely as possible, measurements will be
performed in 2 settings. In the first setting, the subject is lying on a spine
board, on which trauma patients are immobilized. To mimic the situation at the
hospital ward, the subjects will be transferred to a hospital bed.
A Force Sensing Array (FSA) pressure mapping system will be placed around the
pelvis (subjects are only allowed to wear thin clothings underneath). This
pressure mat contains 16x32 pressure sensors and has been designed for
determining skin pressure as readout for the risk of decubitus (dept. of
Dermatology, Erasmus MC). The PCCD is positioned on top of hte FSA mat,
following the protocol of the supplier. One measurement without binder will
serve as control. To reduced biological variation as much as possible, a
cross-over design is chosen, in which all three types of PCCDs will be tested
on each subject, in a randomized order.
Preliminary measurements have revealed that a time frame of 30 minutes in
between two measurements is sufficient to rule out carry over effects.
Study burden and risks
For each PCCD one measurement will be performed, taking up to 20 minutes. There
will be a pause of 30 minutes in between two measurements, summing up to a
total duration of the examination of approximately 2 hours.
Healthy volunteers do not carry a risk of decubitus, as decubitus only occurs
if a continuous pressure of >9.3 kPa (69.8 mmHg) is put on the skin for at
least 2-3 hours.
's Gravendijkwal 230
3015 CE
NL
's Gravendijkwal 230
3015 CE
NL
Listed location countries
Age
Inclusion criteria
Healthy volunteers between 18 and 70 years of age
Exclusion criteria
Bedical history is not blank
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL18718.078.07 |