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

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

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.

Study Overview

• Status: Completed
• Conditions: Wound Contamination
• Intervention / Treatment: Device: Placebo Comparator: 3M™ Tegaderm™ I.V. Advanced Dressing; Device: 3M™ Tegaderm™ CHG I.V. Securement Dressing

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
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Basel-Stadt
    • Basel, Basel-Stadt, Switzerland, 4031
      • Universitatsspital Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EVD-associated infection	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	day 1-X (Explantation)

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• Roethlisberger M, Moffa G, Fisch U, Wiggli B, Schoen S, Kelly C, Leu S, Croci D, Zumofen DW, Cueni N, Nogarth D, Schulz M, Bucher HC, Weisser-Rohacek M, Wasner MG, Widmer AF, Mariani L. Effectiveness of a Chlorhexidine Dressing on Silver-coated External Ventricular Drain-associated Colonization and Infection: A Prospective Single-blinded Randomized Controlled Clinical Trial. Clin Infect Dis. 2018 Nov 28;67(12):1868-1877. doi: 10.1093/cid/ciy393.

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: November 21, 2013
• First Submitted That Met QC Criteria: March 3, 2014
• First Posted (Estimate): March 5, 2014

Study Record Updates

• Last Update Posted (Actual): April 27, 2017
• Last Update Submitted That Met QC Criteria: April 26, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Wound Contamination
• Additional Relevant MeSH Terms: Infections
• Other Study ID Numbers: USB-2013-024