Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:30 PM
Ignite Modification Date:
2025-12-24 @ 4:30 PM
NCT ID:
NCT05741866
Eligibility Criteria:
Inclusion Criteria:
* PIVC to be inserted with expected dwell \>48 hours
* Provided written and informed consent (patient or carer)
Australia only
• ≥6 years of age (due to size of dressing)
France only
• ≥18 years of age
Exclusion Criteria:
* Burned, non-intact or scarred skin at the insertion site
* Known allergy to CHG or transparent dressing adhesives
* Palliative care patients on end-of-life pathway
* Patient who has already participated in the study
* Placement of a PIVC in an emergency, that does not allow the usual rules of hygiene for insertion to be adhered to.
Additional exclusions to Australian study only
* Non-English-speaking patients without interpreter
* Under the care of Child and Family Services and unable to gain consent from case worker (paediatric patients)
Additional exclusions to French study only
* Patients not benefiting from the French Social Security scheme or not benefiting from it through a third party,
* Persons benefiting from enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, adults under legal protection.
* Known pregnant or breastfeeding women
* Predictably difficult vascular access (IV drug addiction, obesity)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Years
Study:
NCT05741866
Study Brief:
Protocol Section:
NCT05741866