Overview

This trial is active, not recruiting.

Condition wound contamination
Treatments 3m™ tegaderm™ chg i.v. securement dressing, placebo comparator: 3m™ tegaderm™ i.v. advanced dressing
Sponsor University Hospital, Basel, Switzerland
Start date October 2013
End date March 2016
Trial size 57 participants
Trial identifier NCT02078830, USB-2013-024

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose prevention
Arm
(Placebo Comparator)
Placebo Dressing with the same shape like the CHG-Dressing without CHG.
placebo comparator: 3m™ tegaderm™ i.v. advanced dressing
Placebo Dressing with the same shape like the CHG-Dressing without CHG.
(Experimental)
- CHG activity at EVD entry site
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.

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)
time frame: Day 5

Secondary Outcomes

Measure
EVD-associated infection
time frame: day 1-X (Explantation)

Eligibility Criteria

Male or female participants from 18 years up to 90 years old.

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

Additional Information

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
Principal investigator Michel Roethlisberger, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by University Hospital, Basel, Switzerland.