Comparison of Two New Generation Dressings in Intensive Care (ADVANCED)

Complication of Catheter Clinical Trial

— ADVANCED  

Official title:

Comparison Between Two Types of Semipermeable Dressings of New Generation in the Prevention of Intravascular Catheters Related Complications in Intensive Care.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01773564
• Other study ID #: 12SC03
• Secondary ID: 2012-A00734-39
• Status: Completed
• Phase: N/A
• First received: November 7, 2012
• Last updated: June 14, 2016
• Start date: October 2012
• Est. completion date: October 2013

Study information

• Verified date: June 2016
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

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 investigators 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.

Description:

randomized controlled trial of 2 intravascular dressings in Intensive care unit

Recruitment information / eligibility

• Status: Completed
• Enrollment: 628
• Est. completion date: October 2013
• Est. primary completion date: October 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Complication of Catheter

Intervention

Device:
• Current hospital dressing
Patients were assigned to either arm following a randomization scheme 1:1.
• 3M™ IV Advanced Securement dressing
Patients were assigned to either arm following a randomization scheme 1:1.

Locations

Country	Name	City	State
France	University Hospital of Grenoble	Grenoble

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	Costs 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 catheter 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