To determine the accuracy and robustness of this method it is necessary to validate it. In the past some successful studies have been performed in adult volunteerd. However we would like to investigate the influence of induced changes to the healing…
ID
Source
Brief title
Condition
- Injuries NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The measurements consist of spectral images of the bruise. Based on these
images the size of the hemoglobin and bilirubin areas can be determined. Using
the change of the size of these areas over time the healing of the bruise can
be monitored and used to see the possible differences between the healing of
the cooled and the uncooled bruise.
Secondary outcome
na
Background summary
Child abuse is a major problem that is more and more acknowledged by our
society. Research of the incidence of child abuse in the Netherlands in 2010
estimates more than 118.000 cases of child abuse among children in the age of 0
to 18 years old (3% of the total population).
Diagnosis of child abuse by a for example a pediatrician is based on certain
factors. One of these factors is the determining the presence of (multiple)
bruises. Knowledge on the age of the bruise can play a very important role in
the determination whether it is a case of abuse. At this moment in time it is
not possible to objectively and accurately determine the age of a bruise. To
make this possible in the future the department of Biomedical Engineering and
Physics is developing a reliable, patient friendly method for the age
determination of bruises.
Using a spectral camera they perform (non invasive) measurements on a bruise.
This camera measures the absorption of different colors of light and makes it
possible to determine the chemical information of the measured surface per
pixel. This makes it possible to detect the different components in a bruise
(hemoglobin, bilirubin) and determine the area where these components are
present in higher concentrations. For the age determination the change in size
of these areas is essential. Using the specially developed 3D model for the age
determination of bruises the age of the bruise can be determined based on the
size of the areas of hemoglobin and bilirubin.
Previous research: The basis of a similar technique lies in Norway, at
Trondheim University. There tests are performed on volunteers showing that it
is possible to determine the age of a bruise with an accuracy of 1 day.
Researchers in the department of Biomedical Engineering & Physics developed and
improved this method method with which they are able to determine the age of a
bruise with an accuracy of 3 hours.
Research question: Does cooling of the bruise have an effect on the healing
process?
Study objective
To determine the accuracy and robustness of this method it is necessary to
validate it. In the past some successful studies have been performed in adult
volunteerd. However we would like to investigate the influence of induced
changes to the healing process. By this we mean that the healing process of the
bruise can be influenced by treating the bruise using methods which are said to
have a possitive or negative effect on the healing of the bruise.
On the internet there is a lot of speculation on the possitive effect of
cooling on the healing process of the bruise. It is said that due to the
cooling the arteries will shrink preventing the bruise from increasing in size.
It also prevents the spread of blood to other locations in the body where it
does not belong. Other resources only indicate that the cooling relieves the
pain.
Because the effect of cooling on the healing process is unclear and might have
an influence on the model for the age determination of bruises we would like to
investigate this into more depth.
Study design
In this study research will be performed on healthy volunteers. For every
participant we will make 2 bruises, 1 on each forearm, in a controlled manner.
One of these bruises will be cooled multiple times during the healing, the
other bruise will heal in a normal manner. The bruises will be measured over
time using a spectral camera to get a good insight of the healing of the
bruise.
Study burden and risks
2 bruises will be inflicted. 1 on each forearm.
These bruises will be measured 10 times. Every measurement will take 5-10
minutes and will be spread over 2 weeks.
Furthermore the bruise will have to be cooled for 2 days, 3 times a day for 15
minutes.
The total burden will be approximately 4 hours.
meibergdreef 9
Amsterdam 1105AZ
NL
meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
18 years and older
participation is on voluntary basis
available during research period
Exclusion criteria
hematologic disorders
osteoporoses
connective tissue disorders that influence the formation on hematoma
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 | NL53322.018.15 |