Wound ContaminationEVDAINCT02078830
Prospective Randomised Study for Use of CHG Dressing at Entry Site of EVD's to Reduce EVD-associated Infections
A study testing 3M™ Tegaderm™ CHG I.V. Securement Dressing in people with Wound Contamination, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Wound Contamination
- What is being tested?
- 3M™ Tegaderm™ CHG I.V. Securement Dressing
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2013to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- Age < 18 years
- Participation in another study involving External Ventricular Drains
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Universitätsspital Basel
Basel, Canton of Basel-City, 4031
About this study
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.
Read the detailed 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.
- Conditions
- Wound Contamination
- Being tested
- 3M™ Tegaderm™ CHG I.V. Securement Dressing, Placebo Comparator: 3M™ Tegaderm™ I.V. Advanced Dressing
- Keywords
- Wound Contamination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Placebo Comparator: 3M™ Tegaderm™ I.V. Advanced DressingDevice
Placebo Dressing with the same shape like the CHG-Dressing without CHG.
| Study group | Role | What they receive |
|---|---|---|
| 3M™ Tegaderm™ I.V. Advanced Dressing | Placebo comparator | Placebo Dressing with the same shape like the CHG-Dressing without CHG. Receives: Device: Placebo Comparator: 3M™ Tegaderm™ I.V. Advanced Dressing |
| 3M™ Tegaderm™ CHG Securement Dressing | Experimental | - CHG activity at EVD entry site Receives: Device: 3M™ Tegaderm™ CHG I.V. Securement Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 5
Secondary outcomes (1)
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
Measured: day 1-X (Explantation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2014 (estimated)
- Study startOct 2013
- Primary completionMar 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Wound ContaminationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luigi Mariani, MD, Study director, Klinik und Poliklinik Neurochirurgie, Spitalstrasse 21, CH-4031 BaselMichel Roethlisberger, MD, Principal investigator, Klinik und Poliklinik Neurochirurgie, Spitalstrasse 21, CH-4031 Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02078830
- Sponsor's protocol ID
- USB-2013-024
- Acronym
- EVDAI
- Status last verified
- Apr 2017
- First submitted
- 21 Nov 2013
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29733329
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02078830
- Acronym / sponsor ID
- EVDAI / USB-2013-024
- Conditions
- Wound Contamination
- Keywords
- Wound Contamination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 5 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3M™ Tegaderm™ I.V. Advanced Dressing | Placebo comparator | Device: Placebo Comparator: 3M™ Tegaderm™ I.V. Advanced DressingPlacebo Dressing with the same shape like the CHG-Dressing without CHG. |
| 3M™ Tegaderm™ CHG Securement Dressing | Experimental | Device: 3M™ Tegaderm™ CHG I.V. Securement Dressing- CHG activity at EVD entry site |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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©)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3M™ Tegaderm™ CHG I.V. Securement DressingChlorhexidine 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. | Device | 3M™ Tegaderm™ CHG Securement Dressing |
| Placebo Comparator: 3M™ Tegaderm™ I.V. Advanced DressingPlacebo Dressing with the same shape like the CHG-Dressing without CHG. | Device | 3M™ Tegaderm™ I.V. Advanced Dressing |
Primary outcome
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
This colonization is proven to be the main source for catheter related infections.
1 secondary outcome
EVD-associated infection
Time frame: day 1-X (Explantation)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2017.
- Derived from this study: PubMed 29733329Roethlisberger 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.
Related trials for Wound Contamination
Not yet recruiting
Vacuum-Assisted Clipper in Preoperative Hair Removal: Effects on Contamination and Skin Integrity
Microbial Contamination, Environmental Contamination
Not yet recruitingPhase 4
Investigation of the PREVENTIA® Irrigation Solution for Reducing Bacteria in Spinal Surgery With Implants - A Comparative Study
Surgical Site Infection (SSI), Spine Surgery
Recruiting
Acne Face Wash for Reducing the Contamination Rate in Arthroscopic Rotator Cuff Repair Surgery
Rotator Cuff Tears of the Shoulder
RecruitingPhase 3
Diluted Aqueous Povidone-Iodine Compared to Saline to Decrease Surgical Site Infections
Surgical Site Infection
Recruiting
Healthy Recovery After Trauma Study
Stress Disorders, Post-Traumatic, Shame
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luigi Mariani, MD study director
Klinik und Poliklinik Neurochirurgie, Spitalstrasse 21, CH-4031 Basel
Michel Roethlisberger, MD principal investigator
Klinik und Poliklinik Neurochirurgie, Spitalstrasse 21, CH-4031 Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3M™ Tegaderm™ CHG I.V. Securement Dressing in people with Wound Contamination, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02078830, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2017.