Wound Contamination Clinical Trial
— EVDAIOfficial 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
Verified date | April 2017 |
Source | University Hospital, Basel, Switzerland |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Universitätsspital Basel | Basel | Basel-Stadt |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Basel, Switzerland |
Switzerland,
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) |
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