Wound Contamination Clinical Trial
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
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.
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.
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