NCT02078830

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: University Hospital, Basel, Switzerland · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Wound Contamination

Interventions

Type	Name	Description
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.
DEVICE	Placebo Comparator: 3M™ Tegaderm™ I.V. Advanced Dressing	Placebo Dressing with the same shape like the CHG-Dressing without CHG.

Timeline

• Start date: 2013-10-01
• Primary completion: 2016-03-01
• Completion: 2017-03-01
• First posted: 2014-03-05
• Last updated: 2017-04-27

Locations

1 site across 1 country: Switzerland