Clinical trial NCT02078830: Prospective Randomised Study for Use of CHG Dressing at Entry Site of EVD's to Reduce EVD-associated Infections
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound Contamination
Keywords: Wound Contamination
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2014-03-05
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: difference in bacterial contamination (CFU/cm2) of the EVD entry-site after 5 days as compared to baseline (CountTact™ skin sample III)
timeFrame: Day 5
Secondary outcomes:
measure: EVD-associated infection
timeFrame: day 1-X (Explantation)
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Universitätsspital Basel
state: Basel-Stadt
Study officials:
affiliation: Klinik und Poliklinik Neurochirurgie, Spitalstrasse 21, CH-4031 Basel
name: Luigi Mariani, MD
role: STUDY_DIRECTOR
affiliation: Klinik und Poliklinik Neurochirurgie, Spitalstrasse 21, CH-4031 Basel
name: Michel Roethlisberger, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.