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

Wound Contamination Clinical Trial

— EVDAI  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02078830
• Other study ID #: USB-2013-024
• Status: Completed
• Phase: N/A
• First received: November 21, 2013
• Last updated: April 26, 2017
• Start date: October 2013
• Est. completion date: March 2017

Study information

• Verified date: April 2017
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: March 2017
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Wound Contamination

Intervention

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

Locations

Country	Name	City	State
Switzerland	Universitätsspital Basel	Basel	Basel-Stadt

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	difference in bacterial contamination (CFU/cm2) of the EVD entry-site after 5 days as compared to baseline (CountTact™ skin sample III)	This colonization is proven to be the main source for catheter related infections.	Day 5
Secondary	EVD-associated infection	The secondary Endpoint is: • EVD-associated infection [according 4.3.3] is defined through a mandatory combination of: Presence of bacteria at additional timepoints and from additional sampling: culture from CSF every 2nd day until EVD-explantation; sonication of distal 4.5 cm (tip) and subsequent 5 cm (tunneled) EVD- part after explantation on day x; clinical signs as fever, meningism, Glasgow Coma Scale (GCS)-drop and blood signs of infection	day 1-X (Explantation)