Comparison of Two New Generations Dressings in Intensive Care Unit

Catheter Related Complications Clinical Trial

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Official title:

Comparison Between Two New Generation Dressings in the Prevention of Intravascular Catheter Related Complications in Intensive Care Units

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01795391
• Other study ID #: ADVANCED
• Status: Completed
• Phase: N/A
• First received: February 18, 2013
• Last updated: January 20, 2014
• Start date: October 2012
• Est. completion date: November 2013

Study information

• Verified date: January 2014
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational

Clinical Trial Summary

Intravascular devices in intensive care units are often associated to complications. The investigators estimate that 23.5% of catheters placed and used in intensive care are subject to at least one complication; the goal is to demonstrate the effectiveness of the new Tegaderm ™ IV Advanced dressings to achieve a decrease of 35% in the number of complications associated with intravascular catheters in intensive care.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 685
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients over 18 years with a central venous catheter, an arterial catheter, a hemodialysis catheter, a Swan Ganz catheter or a peripheral catheter inserted in the ICU or within the 24 before their arrival at the ICU in another ICU setting.

• Patients benefiting from the social security protection.

Exclusion Criteria:

• Patients under 18 years of age,

• Patients having known allergy or sensitivity to adhesive dressing materials

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Catheter Related Complications

Locations

Country	Name	City	State
France	University Hospital of Grenoble, Medical Intensive Care Unit	Grenoble	Isère

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants presenting allergic adverse events.		From the insertion of the catheter to its removal, an average time frame thant can go up to 4 weeks.	No
Other	Cost of each dressing type strategy.		From the insertion of the catheter to its removal, an average time frame thant can go up to 4 weeks.	No
Primary	Number of catheters presenting any kind of complications.		From the insertion of the catheter to its removal, an average time frame thant can go up to 4 weeks.	No
Secondary	Number of infections related to poor adherent dressings.		From the insertion of the catheter to its removal, an average time frame thant can go up to 4 weeks.	No