Preventing Catheter Related Infection Clinical Trial
— CLEAN| NCT number | NCT01629550 |
| Other study ID # | CLEAN |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 4 |
| First received | June 20, 2012 |
| Last updated | October 10, 2016 |
| Start date | October 2012 |
Catheter related infection is the third cause of nosocomial infection in ICUs. Most of them
are avoidable and can be prevent by improving aseptic practices during catheter insertion
and maintenance. Indeed, the main route of catheter contamination for short-term catheters
is the insertion site. Consequently, the quality of skin disinfection is the most effective
preventive measure to reduce the incidence of these infections.
This aim of the present study is to compare four strategies of skin disinfection to
determine whether a 2% alcoholic solution of chlorhexidine acts better than 5% alcoholic
povidone iodine in reducing catheter infection and to assess whether a detersion phase prior
to disinfection reduces catheter colonization as compared with no detersion.
| Status | Completed |
| Enrollment | 2400 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - = 18 year-old - Expected duration of ICU stay = 48 hours - Patient requiring the insertion of at least one arterial catheter and/or central venous catheter and/or catheter for hemodialysis. Exclusion Criteria: - Patient with history of allergy to any of the antiseptic agent studied - Expected survival < 48 hours - Catheter inserted outside the ICU or in emergency without respect of preventive measures. - Use of antimicrobial impregnated catheters or antiseptic impregnated dressings. - Pregnant woman or breast-feeding mother |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| France | Angers University Hospital | Angers | |
| France | Estain University Hospital | Clermont-Ferrand | |
| France | Bichat-Claude Bernard Hospital | Paris | |
| France | Lyon University Hospital | Pierre Benite | |
| France | Poitiers University Hospital | Poitiers |
| Lead Sponsor | Collaborator |
|---|---|
| Poitiers University Hospital |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Major catheter related infection | No | ||
| Secondary | Catheter colonization | No | ||
| Secondary | Catheter related bacteremia | No | ||
| Secondary | Colonization insertion site | No | ||
| Secondary | Prolongation hospitalization due to catheter infection | No | ||
| Secondary | Mortality due to catheter infection | No | ||
| Secondary | Skin allergy and anaphylactic shock | Yes | ||
| Secondary | Costs | No |