We aim to study the efficacy of honey to prevent skin colonization with microflora at central venous catheter insertion sites.
ID
Source
Brief title
Condition
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter is frequency of positive skin swabs cultures at the
last sampling point before removal of the catheter, or before the patient
leaves the intensive care department.
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forearm skin (unpublished data).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 central venous catheter insertion site colonization.
Study objective
We aim to study the efficacy of honey to prevent skin colonization with
microflora at central venous catheter insertion sites.
Study design
1. Prior to insertion of the catheter, a 3 x 3 cm area of skin at the catheter
insertion site is sampled with a saline-moistened cotton swab which is
quantitatively cultured to assess skin microflora.
2. Standard procedures will be performed for skin disinfection.
3. The 3x3 cm area of skin at the catheter insertion site is sampled again to
assess colonization after skin disinfection.
4. Catheter is inserted according to standard procedures.
5. In the treatment group, medical grade honey is applied on a sterile gauze
which is placed on the skin at the catheter insertion site. In the control
group a gauze without honey will be applied. Subsequently, the catheter
insertion sites are covered with standard wound dressing (Tegaderm®).
6. Catheter insertion site dressings will be changed on a daily basis. After
removing the dressing, the skin will be sampled with saline-moistened cotton
swabs to assess the colonization. Next, the insertion site will be disinfected
according to standard intensive care procedures, and new dressings with or
without honey will be applied.
Intervention
see 'study design'
Study burden and risks
During the insertion period of the catheter, a gauze with or without honey will
be changed on a daily basis. Immediately prior to and after disinfection of
skin before insertion of the catheter, and at daily dressing change, the skin
will be sampled with saline-moistened cotton swabs to assess 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
Immunosuppression by >5 mg prednisone daily, or any other immunosuppressive agent, in relation to organ transplantation or autoimmune disease
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 | NL17122.018.07 |