NCT02078830

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 5, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

April 27, 2017

Status Verified

April 1, 2017

Enrollment Period

2.4 years

First QC Date

November 21, 2013

Last Update Submit

April 26, 2017

Conditions

Wound Contamination

Keywords

Wound Contamination

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • EVD-associated infection

    day 1-X (Explantation)

Study Arms (2)

3M™ Tegaderm™ I.V. Advanced Dressing

PLACEBO COMPARATOR

Placebo Dressing with the same shape like the CHG-Dressing without CHG.

Device: Placebo Comparator: 3M™ Tegaderm™ I.V. Advanced Dressing

3M™ Tegaderm™ CHG Securement Dressing

EXPERIMENTAL

\- CHG activity at EVD entry site

Device: 3M™ Tegaderm™ CHG I.V. Securement Dressing

Interventions

3M™ Tegaderm™ CHG I.V. Securement DressingDEVICE

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.

3M™ Tegaderm™ CHG Securement Dressing
Placebo Comparator: 3M™ Tegaderm™ I.V. Advanced DressingDEVICE

Placebo Dressing with the same shape like the CHG-Dressing without CHG.

3M™ Tegaderm™ I.V. Advanced Dressing

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsspital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

Related Publications (1)

  • Roethlisberger M, Moffa G, Fisch U, Wiggli B, Schoen S, Kelly C, Leu S, Croci D, Zumofen DW, Cueni N, Nogarth D, Schulz M, Bucher HC, Weisser-Rohacek M, Wasner MG, Widmer AF, Mariani L. Effectiveness of a Chlorhexidine Dressing on Silver-coated External Ventricular Drain-associated Colonization and Infection: A Prospective Single-blinded Randomized Controlled Clinical Trial. Clin Infect Dis. 2018 Nov 28;67(12):1868-1877. doi: 10.1093/cid/ciy393.

    PMID: 29733329DERIVED

Study Officials

  • Luigi Mariani, MD

    Klinik und Poliklinik Neurochirurgie, Spitalstrasse 21, CH-4031 Basel

    STUDY DIRECTOR

  • Michel Roethlisberger, MD

    Klinik und Poliklinik Neurochirurgie, Spitalstrasse 21, CH-4031 Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2013

First Posted

March 5, 2014

Study Start

October 1, 2013

Primary Completion

March 1, 2016

Study Completion

March 1, 2017

Last Updated

April 27, 2017

Record last verified: 2017-04

Locations

CH(1)