Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT02078830
Study type Interventional
Source University Hospital, Basel, Switzerland
Contact
Status Completed
Phase N/A
Start date October 2013
Completion date March 2017

See also
  Status Clinical Trial Phase
Completed NCT04507724 - The Use of Biochemical Analyzes to Monitor the Development of Wounds
Completed NCT02413879 - Cleancision IntRaoperative Contamination prEvention Study N/A
Not yet recruiting NCT04214236 - CiNPT for Abdominoplasties in Post-bariatric Patients Study N/A
Recruiting NCT03290690 - Positive Predictive Value (PPV) of Pseudomonas Aeruginosa