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NCT Number: NCT02078830

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

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.

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Key information

Conditions

Wound Contamination

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitätsspital Basel

Basel, Canton of Basel-City, 4031, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3M™ Tegaderm™ CHG I.V. Securement Dressing

Device

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.

Placebo Comparator: 3M™ Tegaderm™ I.V. Advanced Dressing

Device

Placebo Dressing with the same shape like the CHG-Dressing without CHG.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study 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

Acronym: EVDAI

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Mar 5, 2014
Registry last updated
Apr 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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