This product is a skin disinfectant and therefore is not specific for a medical condition. It will be used where patients require skin disinfection prior to peripheral vascular catheterisation
Conditions
Interventions
Trade Name: ChloraPrep:
FDA: NDC 054365/400/01
Product Name: ChloraPrep
Product Code: 260400 and 260449
Pharmaceutical Form: Cutaneous solution
INN or Proposed INN: 2%w/v Chlorhexidine Gluconate in 70
Sponsors
Medi-Flex
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient and healthcare worker inclusion criteria Patient -Must be at least 18 years of age. -Require a PVC as part of their clinical management. -Willing and able to provide verbal consent. Healthcare worker -Competent to insert PVC as part of their clinical practice. -Completion of the study training programme. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patient and healthcare worker exclusion criteria Patient Any patient may withdraw from the study at their own request for any reason, or at the request of their medical team, the Clinical Research Nurse, the Principal Investigator or in the case of an adverse event. History of psychiatric problems or mental handicap, breast feeding and pregnant women, anyone less than 18 years of age, patients unable to give informed consent. Healthcare worker Any healthcare worker may withdraw from the study at their own request for any reason, or at the request of the Clinical Research Nurse or Principal Investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of 70% isopropyl alcohol (standard treatment) and 2% chlorhexidine gluconate in 70% isopropyl alcohol (chloraprep) for the disinfection of skin prior to peripheral vascular catheterisation.;Secondary Objective: ;Primary end point(s): A total of 900 patients will be recruited into the trial: 450 in the trial group and 450 in the control group. The prodct will be used once to disinfect the skin prior to each insertion of a peripheral vascular catheter. | — |
Countries
United Kingdom
Outcome results
None listed