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

University Hospital Basel

Status

Completed

Conditions

Wound Contamination

Treatments

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

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

Study type

Interventional

Funder types

Other

Identifiers

NCT02078830

USB-2013-024

Details and patient eligibility

About

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.

Full 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.

Enrollment

57 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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