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Efficacy of Medical Grade Honey to prevent Catheter Insertion Site Colonization of Intensive Care Patients.


- candidate number5265
- NTR NumberNTR1652
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-feb-2009
- Secondary IDs80-82305-98-09039  ZonMW
- Public TitleEfficacy of Medical Grade Honey to prevent Catheter Insertion Site Colonization of Intensive Care Patients.
- Scientific TitleEfficacy of Medical Grade Honey to prevent Catheter Insertion Site Colonization of Intensive Care Patients.
- ACRONYMEfficacy of Medical Grade Honey to prevent Catheter Insertion Site Colonization of Intensive Care Patients
- hypothesisDaily application of medical grade honey will prevent colonization of central venous catheter insertion sites of intensive care patients.
- Healt Condition(s) or Problem(s) studiedCatheter infections
- Inclusion criteria1. Presence of a central venous catheter;
2. >= 18 years of age;
3. Admission to department of intensive care of the AMC with an expected stay of at least 2 days.
- Exclusion criteria1. Infectious skin diseases;
2. Other skin diseases that can be considered to influence microbial colonization;
3. Immunosuppression by >5 mg prednisone daily, or any other immunosuppressive agent, in relation to organ transplantation or autoimmune disease.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 9-feb-2009
- planned closingdate31-dec-2010
- Target number of participants270
- InterventionsCentral venous catheters are inserted according to standard procedures. In the treatment group, Revamil medical grade honey (Bfactory health products, The Netherlands) 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. The catheter insertion site will be covered with transparant polyurethane dressing. 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 and the insertion site will be disinfected with 0.5% chlorhexidine in 70% ethanol according to standard intensive care procedures, and new dressings with or without honey will be applied. Catheters must be included in the study within 48 hours after insertion, and sampling will be performed until the catheter is removed or the patient leaves the ICU.
- Primary outcomeFrequency of positive skin swab cultures of catheter insertion sites at the last sampling point.
- Secondary outcome1. Frequency of positive skin swab cultures of catheter insertion sites over time;
2. The level of colonization of catheter insertion sites as measured in numbers of colony-forming units; analysis of the last sampling point and analysis over time;
3. Stratification of the above mentioned analyses by location of the catheters.
- TimepointsSampling of the catheter insertion sites will be performed on a daily basis until the catheter is removed or the patient leaves the ICU.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. S.A.J. Zaat
- CONTACT for SCIENTIFIC QUERIESDr. S.A.J. Zaat
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief 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. 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. In this study we will assess the efficacy of honey to prevent skin colonization with microflora at central venous catheter insertion sites. 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 gauze is covered with standard wound dressing. 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. The primary study parameter is frequency of positive skin swab cultures of catheter insertion sites at the last sampling point."
- Main changes (audit trail)
- RECORD4-feb-2009 - 14-sep-2009


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