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Prospective Randomised Study for Use of CHG Dressing at Entry Site of EVD's to Reduce EVD-associated Infections (EVDAI)

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ClinicalTrials.gov Identifier: NCT02078830
Recruitment Status : Completed
First Posted : March 5, 2014
Last Update Posted : April 27, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief Summary:
The objective of this study is to assess the efficacy of 3M™ Tegaderm™ CHG I.V. Securement Dressing at the entry-site of a EVD in reducing quantity of microorganisms (CFU/cm2) after a time period of 5 days as a surrogate marker for EVD-associated infections [1, 2], compared to a nonantimicrobial polyurethane 3M Tegaderm™ Transparent Film Dressing. We aim to investigate, if the adjunct of an additional CHG-impregnated device on a routinely basis for the daily care is as a valuable and effective option to reduce contamination of the EVD entry-site and consecutive colonization of the catheter.

Condition or disease Intervention/treatment Phase
Wound Contamination Device: 3M™ Tegaderm™ CHG I.V. Securement Dressing Device: Placebo Comparator: 3M™ Tegaderm™ I.V. Advanced Dressing Not Applicable

Detailed Description:

Randomised, parallel group, single-centre Phase IV trial comparing the change in the quantity of microorganisms (CFU/cm2) after a time period of 5 days (primary endpoint) as surrogate marker for EVD-associated infections [1, 2], in patients undergoing EVD with dressing at the entry site with 3M™ Tegaderm™ CHG I.V. Securement Dressing (study arm) versus 3M™ Tegaderm™ I.V. Advanced Dressing (standard arm). Secondary objectives are the comparison of regrowth (CFU/cm2) every 5th day before routine change of the device, cerebrospinal fluid (CSF) cultures every 2nd day and sonication of the catheter tip after explantation (secondary endpoints).

We hypothesize that bacterial contamination (CFU/cm2) of the EVD entry-site after 5 days compared to baseline (bacterial regrowth since baseline) in subjects treated with the 3M™ Tegaderm™ CHG I.V. Securement Dressing is significantly lower compared to subjects treated with 3M™ Tegaderm™ I.V. Advanced Dressing. Quantitative microbiology of the catheter tip (sonication) might be reduced by this external intervention, as well as CSF cultures.

We will use an internal pilot study design [3]. The three step procedure includes:

  • initial sample size calculation
  • sample size review
  • final analysis.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: EXTERNAL VENTRICULAR DRAIN ASSOCIATED INFECTIONS STUDY (EVDAI-STUDY) - A Prospective Randomised Microbiological Study for Use of 3M™ Tegaderm™ Chlorhexidinegluconate Dressing at Entry Site of EVD's to Reduce EVD-associated Infections
Study Start Date : October 2013
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2017

Arm Intervention/treatment
Placebo Comparator: 3M™ Tegaderm™ I.V. Advanced Dressing
Placebo Dressing with the same shape like the CHG-Dressing without CHG.
Device: Placebo Comparator: 3M™ Tegaderm™ I.V. Advanced Dressing
Placebo Dressing with the same shape like the CHG-Dressing without CHG.

Experimental: 3M™ Tegaderm™ CHG Securement Dressing
- CHG activity at EVD entry site
Device: 3M™ Tegaderm™ CHG I.V. Securement Dressing
Chlorhexidine gluconate (CHG) has been dissolved into a soft gel pad (3x4 cm) to provide a reservoir for consistent and continuous antimicrobial action over time. The gel pad is active on contact without requiring additional moisture. CHG migrates under the catheter to provide continuous circumferential antimicrobial protection at the insertion site. Soft and conformable, the gel pad moulds around the catheter and hub.




Primary Outcome Measures :
  1. difference in bacterial contamination (CFU/cm2) of the EVD entry-site after 5 days as compared to baseline (CountTact™ skin sample III) [ Time Frame: Day 5 ]
    This colonization is proven to be the main source for catheter related infections.


Secondary Outcome Measures :
  1. EVD-associated infection [ Time Frame: day 1-X (Explantation) ]

    The secondary Endpoint is:

    • EVD-associated infection [according 4.3.3] is defined through a mandatory combination of:

    • Presence of bacteria at additional timepoints and from additional sampling:
    • culture from CSF every 2nd day until EVD-explantation
    • sonication of distal 4.5 cm (tip) and subsequent 5 cm (tunneled) EVD- part after explantation on day x
    • clinical signs as fever, meningism, Glasgow Coma Scale (GCS)-drop and blood signs of infection



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Patients following the criteria cited below are included: Patients undergoing implantation of an external ventricular drain (EVD), frontal or occipital, due to a given underlying pathology.

  • Written informed consent (IC) by patients and/or independent physician [according 5.1]
  • Age ≥ 18 years

Exclusion Criteria:

  • Patients presenting one of the criteria cited below are excluded:
  • Presence of clinical signs or laboratory findings suspicious infection
  • Presence of antibiotic intake
  • Traumatic Brain Injury (TBI) with evident or suspected dural breach (including skull base)
  • Decision for Rifampin impregnated ventricular catheter (Bactiseal©)
  • Known hypersensitivity to chlorhexidine (people from Japanese origin)
  • Age < 18 years
  • Participation in another study involving External Ventricular Drains
  • Pregnancy or breastfeeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02078830


Locations
Switzerland
Universitätsspital Basel
Basel, Basel-Stadt, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Study Director: Luigi Mariani, MD Klinik und Poliklinik Neurochirurgie, Spitalstrasse 21, CH-4031 Basel
Principal Investigator: Michel Roethlisberger, MD Klinik und Poliklinik Neurochirurgie, Spitalstrasse 21, CH-4031 Basel

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT02078830     History of Changes
Other Study ID Numbers: USB-2013-024
First Posted: March 5, 2014    Key Record Dates
Last Update Posted: April 27, 2017
Last Verified: April 2017

Keywords provided by University Hospital, Basel, Switzerland:
Wound Contamination