Our study will measure several different symptoms/aspects of cellulitis, such as redness, swelling, warmth, pain, fluctuation, ulceration and drainage. Each of these aspects will be scored on a scale of 0-3, adding up to a maximum total score of 21…
ID
Source
Brief title
Condition
- Bacterial infectious disorders
- Skin and subcutaneous tissue disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Inter-rater variability
Intra-rater variability
Responsiveness
Secondary outcome
none
Background summary
There are few good outcome measures in clinical cellulitis research. Mortality
is low and thus cannot be used, and neither can bacteriological cure, due to
cultures often being negative or possibly false positive. Subjective measures
such as "cured as decreed by clinician" are unreliable, as a large portion of
the patients can have a remaining red and swollen cellulitis laesion, while all
bacteria are already dead (at which point treatment is effectively done). At
the moment, only redness is being used as primary outcome measure (therapy is
said to be effective if there is a cessation of the spread of redness), but
this is a derived outcome measure. A numerical outcome measure, such as blood
pressure in hypertension treatment, does not exist. For research purposes, it
would be useful to have an outcome measure that can tell in both an early and
late stage if treatment is effective.
Study objective
Our study will measure several different symptoms/aspects of cellulitis, such
as redness, swelling, warmth, pain, fluctuation, ulceration and drainage. Each
of these aspects will be scored on a scale of 0-3, adding up to a maximum total
score of 21. 10 patients will be evaluated by 3 physicians on 3 timepoints.
This allows us to look at inter- and intra-rater variability, and at whether
the instrument is able to pick up changes (responsiveness). This is the first
step to developing a useful tool in research.
Study design
Patients will be asked in the first 24 hours of their admission in the AMC if
they want to participate, and if yes:
- within 3 hours, 3 physicians will evaluate the cellulitis laesion
- 3-12 hours after the first evaluation, 3 more evaluations will take place by
the same physicians
- on the 3rd day, 3 more evaluations will take place within 4 hours
Legs with compression bandages will be relieved of their bandages during these
time periods.
This gives us 9 scores per patient, which can be compared with eachother to
calculate inter- and intra-rater variablity and responsiveness.
Study burden and risks
There should be no risk involved for the patients, but the measuring procedure
might be painful for a short duration in some patients.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
- Aged 18 or older
- Admitted with clinical diagnosis of cellulitis (roughly defined as red, warm and indurated skin, with or without pain)
Exclusion criteria
- Cellulitis on other site than arm or leg
- Non-white skin color
- Pre-existent erythematous or edematous (skin)abnormalities at the site of the cellulitis laesion (e.g. dermatitis, lymphedema, deep venous thrombosis sequelae)
- No informed consent
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 | NL50352.018.15 |