The primary objective of this study is to evaluate if there are differences in the tissue-interface pressures, pressures inside the tissues and tissue deformation in the sacral area when volunteers lie on a regular spineboard versus a vacuum…
ID
Source
Brief title
Condition
- Tissue disorders NEC
- Injuries NEC
- Skin and subcutaneous tissue disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters are the differences in tissue-interface pressure map, the
MRI scan, internal pressures and tissue deformation for the devices.
Secondary outcome
Not applicable
Background summary
Victims of a serious accident are placed on a spineboard or a vacuum mattress
by ambulance personnel for extrication from the site of the accident and
transfer to a hospital. One major disadvantage of these devices is that they
have a hard surface, leading to discomfort for the patient and increasing the
risk of developing pressure ulcers as a consequence. The development of a
soft-layered long spineboard addresses these objections by providing the
rigidity of the spineboard with the comfort and low tissue-interface pressures
of a mattress. The current study aims to clarify whether these devices are
associated with different profiles for specific parameters associated with the
development of pressure ulcers.
Study objective
The primary objective of this study is to evaluate if there are differences in
the tissue-interface pressures, pressures inside the tissues and tissue
deformation in the sacral area when volunteers lie on a regular spineboard
versus a vacuum mattress or a soft-layered long spineboard.
Study design
The design is a prospective, randomised non-blinded cross-over study.
Intervention
The sacral area of volunteers is scanned in a MRI scanner four times: once in
prone position and three times in supine position. Furthermore,
tissue-interface pressure measurements are performed with the volunteer in
supine position for each of the three devices.
All interventions are non-invasive.
Study burden and risks
The burden of this study consists of a time-investment of about 60 minutes per
volunteer, in one site visit. The risk of developing stage 1 pressure ulcers is
negligible since the time spent on the devices is less than the time generally
needed to develop a pressure ulcer. Discomfort from lying on the devices will
be minimal since time spent on the devices is limited to a maximum of five
minutes at a time.
There are no direct benefits for the volunteers. However, future patients may
benefit from the knowledge generated in this study for the prevention of
pressure ulcers.
P. Debyelaan 25
6229 HX Maastricht
NL
P. Debyelaan 25
6229 HX Maastricht
NL
Listed location countries
Age
Inclusion criteria
- Healthy volunteers
- Age 18 or over
- Decision-making capability
Exclusion criteria
- Complaints of pain or discomfort directly before participation
- Diseases or complaints of the skin, vascular system, nervous system, skeletal system, or other diseases influencing the capability of soft tissues to recover from damage, including diabetes
- Medical history of pressure ulcers
- Standard contra-indications for MRI scanning (metallic prosthesis, pacemaker device, etc)
- Scars or other tissue deformations in the sacral area
Design
Recruitment
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 | NL35919.068.11 |