|- candidate number||26756|
|- NTR Number||NTR6264|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||24-feb-2017|
|- Secondary IDs||16-N-178 |
|- Public Title||Coatings in health care|
|- Scientific Title||Implementation of antimicrobial coatings in health care|
|- hypothesis||The implementation of antimicrobial coatings in health care results in an improved hygienic environment to support patient recovery and lowers the risk of a health care associated infection.|
|- Healt Condition(s) or Problem(s) studied||Microflora, Antimicrobial prophylaxis|
|- Inclusion criteria||None|
|- Exclusion criteria||None|
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||28-feb-2017|
|- planned closingdate||31-dec-2018|
|- Target number of participants||0|
|- Interventions||In every hospital 2 rooms will be treated with an TiO2-based coating system to prevent microbiological colonisation of contact surfaces.|
Two rooms will recieve a sham-coating without TiO2, a placebo like approach.
Rooms are located on the same department next to eachother.
Patients are placed in patient rooms at random, since coating is regarded as safe and no intervention in patient treatment is introduced.
|- Primary outcome||A reduction in presence of pathogenic micro-organisms in the room of the patient|
|- Secondary outcome||A reduction in presence of micro-organisms in the room of the patient.
|- Timepoints||1, 3, 6, 12 and 18 months after coating|
|- Trial web site||-|
|- status||recruitement status not public|
|- CONTACT FOR PUBLIC QUERIES||Dr. Francy R.L. Crijns|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Francy R.L. Crijns|
|- Sponsor/Initiator ||VieCuri Medisch Centrum voor Noord-Limburg, Zuyderland Medical Center, Heerlen, Zuyderland Hospital, Zuyd University of Applied Sciences, Research Centre for Autonomy and Participation of people with a chronic illness|
(Source(s) of Monetary or Material Support)
|Stichting Innovatie Alliantie (SIA), Zuyderland MC, Zuyd University of Applied Sciences, Heerlen|
|- Publications||Comparative performance of a panel of commercially available antimicrobial nanocoatings in Europe.
|- Brief summary||Annually over 4 million patients acquire an infection while being admitted in healthcare, for about
1% of these patients this infection is the direct cause of death. Combined with the increase in antimicrobial resistance of microorganisms over the last decades, these healthcare associated infections pose a general threat for our healthcare system with substantial financial consequences.|
The implementation of antimicrobial coatings as a preventive measure for bacterial colonisation and migration in a healthcare setting is proposed to be the solution for hospital wide outbreaks caused by organisms like Pseudomonas spp., Klebsiella spp., MRSA and VRE. This study focusses on the implementation of a photocatalytic TiO 2 coating on surfaces surrounding the patient in the patient ward of a Medical Centre with a general focus on the antimicrobial efficacy of the coating in a real-
|- Main changes (audit trail)|
|- RECORD||24-feb-2017 - 24-mei-2017|