In this study we want to investigate if there are differences in cytokine and mFABp production when using a rigid and a soft-layered spineboard, in relation to tissue-interface pressures. Furthermore, redness of the skin and experienced comfort areā¦
ID
Source
Brief title
Condition
- Tissue disorders NEC
- Injuries NEC
- Skin and subcutaneous tissue therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Cytokine and mFABp production
Secondary outcome
Tissue-interface pressures as measured by a pressure mapping mat
Redness of the skin
Xomfort of lying on the spineboard.
Background summary
Accident victims who are at risk for spinal column injury are transported to
the hospital on a rigid spineboard, as indicated in protocols. Patient
transport on a rigid spineboard has inherent risks: because of the rigid
surface, there is a chance of developing pressure ulcers, especially when the
patient lies on the rigid spineboard for a prolonged time. Furthermore, the
lack of comfort due to lying on a rigid surface may cause unrest in the
patient, leading to shifting to find a more comfortable position. When the
patient has an unstable fracture of the spine, the shifting may lead to
worsening of the injury. In the worst case, this may lead to paralysis due to
(further) damage of the spinal cord by the moving fracture parts. It is
therefore of utmost importance to be able to offer the patient an alternative,
which accommodates the objections of discomfort and the risk of pressure ulcer
development.
Study objective
In this study we want to investigate if there are differences in cytokine and
mFABp production when using a rigid and a soft-layered spineboard, in relation
to tissue-interface pressures. Furthermore, redness of the skin and experienced
comfort are documented.
Study design
Prospective, randomized intervention study
Intervention
Subjects lie on both spineboards for a period of three times twenty minutes.
Photographs are made of the skin of the back/buttocks. Every twenty minutes
sebutapes are (re)placed on in advance marked places of the skin.
Tissue-interface pressures are registered continuously using a pressure mapping
mat which is placed on top of the spineboard. Comfort is scored using a visual
analog scale.
Study burden and risks
The burden of this study consists of a time investment of two time three hours.
In this time, the skin of the back and buttocks are judged on redness multiple
times and photographs are taken of this area. Subjects lie on the spineboard
for a total of one hour during both sessions. For the remainder of the time
they are not allowed to lie on their back en sit down (standing up and lieing
on the side or prone is allowed) During the entire session sebutapes are
(re)placed on in advance marked out places of the body. This is a non-invasive,
painfree procedure.
Subjects are at minimal risk to develop non-blanchable erythema (grade 1
pressure ulcer) of the skin. This risk however is very small due to the limited
time the subjects spends on the spineboard. Furthermore, in an earlier study
(NL 18313.068.07) patients have been lying on the rigid spineboard for a
maximum of two hours. None of the participants developed non-blanchable nedness
(grade 1 pressure ulcer).
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
Caucasian males
Age 20-30 years
Body Mass Index (BMI) 19-25
Exclusion criteria
History of pressure ulcers
Skin conditions such as eczema, rashes, psoriasis with local expression on the buttocks/sacrum.
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 | NL49146.068.14 |