Determine the efficacy of medical grade honey to reduce or prevent bacterial colonization at skin of intensice care patients.
ID
Source
Brief title
Condition
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Reduction in number of culture-positive skin segments
Reduction in number of bacteria colonizing skin segments
Secondary outcome
Not applicable
Background summary
Catheter-related bloodstream infections form a serious problem in critically
ill patients. These infections may originate either from the skin microflora
(extraluminal source), or from contaminated hubs or fluids (intraluminal
source). Although the skin is intensively disinfected prior to catheter
insertion and a sterile dressing is applied, micro-organisms residing in e.g.,
hair follicles re-colonize the skin under the dressing. Application of medical
grade honey might result in prolonged disinfection of skin around
catheter-insertion sites.
Medical grade honey has antimicrobial activity through its high sugar content,
the presence of glucose-oxidase producing hydrogen peroxide, low pH and
additional yet unidentified bactericidal compounds. Honey has been tested for
its clinical applicability with promising results.
At the department of Medical Microbiology at the AMC, the antimicrobial
activity of medical grade honey was determined. In a pilot-study with healthy
volunteers, we showed that medical grade honey strongly reduces colonization of
forearm skin (unpublished data). We aim to assess the efficacy of medical grade
honey to reduce skin colonization and prevention of catheter-associated
infections.
Study objective
Determine the efficacy of medical grade honey to reduce or prevent bacterial
colonization at skin of intensice care patients.
Study design
After the pilot study with healthy volunteers, we aim to assess the efficacy of
medical grade honey for intensive care patients. The procedure is as follows:
1. Two areas of skin (3 x 3 cm) of each forearm are sampled with cotton swabs,
which are quantitatively cultured to assess skin microflora prior to
application of
medical grade honey.
2. Two skin patches on the right forearm are disinfected en sampled again with
cotton swabs to assess the efficacy of disinfection.
3. All four patches of skin are covered with standard wound dressing
(Tegaderm®), two with and two without medical grade honey.
4. After 2 days, the wound dressings are removed and the skin under the
dressings is sampled with swabs and quantitatively cultured. After this
procedure all four skin patches are disinfected.
Intervention
see 'study design'
Study burden and risks
Four Tegaderm dressings will be applied on forearm skin, two with and two
without medical grade honey. After 2 days the dressings will be removed. Prior
to, and after two days incubation, the skin segments are sampled using a cotton
swab to determine bacterial colonization.
Meibergdreef 15
1105AZ Amsterdam
Nederland
Meibergdreef 15
1105AZ Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
admittance to Intensive Care for at least 48 h
Exclusion criteria
Infectious skin diseases
Other skin diseases that can be considered to influence microbial colonization
Defective immunity
Allergic reaction to Tegaderm dressing
fragile skin, e.g., due to corticosteroid treatment
Design
Recruitment
Medical products/devices used
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In other registers
Register | ID |
---|---|
CCMO | NL13913.000.06 |