Dressing: Frequency of Change and Evaluation of an Antiseptic-Impregnated Catheter Dressing in ICU Patients (DRESSING)

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT00417235
First received: December 28, 2006
Last updated: June 13, 2008
Last verified: June 2008
  Purpose

The purpose of this study is to determine whether a catheter dressing every 7th day is not inferior to a catheter dressing every 3 days and if Chlorhexidine impregnated sponges are effective in preventing catheter-related infections in ICUs.


Condition Intervention Phase
Systemic Inflammatory Response Syndrome
Bacteremia
Device: Chlorhexidine Sponge (Biopatch TM)
Behavioral: 3-day or 7-day catheter dressing frequency
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Dressing: Comparison of 3-Day and 7-Day Catheter Dressing Frequency and Efficacy of Antiseptic Impregnated Dressing in Preventing Catheter-Related Infection in ICU

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • Systemic catheter related sepsis as defined by a blinded expert panels to unmask differences between Chlorhexidine dressings and no Chlorhexidine dressings [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Significant catheter culture >=103 cfu/ml for non inferiority between 7 days and 3 day catheter-dressing frequencies [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • catheter related septicemia [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • cutaneous allergy [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
  • cost [ Time Frame: within the 60 days after catheter insertion ] [ Designated as safety issue: No ]

Estimated Enrollment: 1600
Study Start Date: January 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
3-days chlorexidrine impregnated sponge
Device: Chlorhexidine Sponge (Biopatch TM)
dressing with chlorexidrine sponge versus dressing without chlorexidrine sponge
Behavioral: 3-day or 7-day catheter dressing frequency
dressing changes every 7 days versus every 3 days
No Intervention: 3
7-days chlorexidrine impregnated sponge
Device: Chlorhexidine Sponge (Biopatch TM)
dressing with chlorexidrine sponge versus dressing without chlorexidrine sponge
Behavioral: 3-day or 7-day catheter dressing frequency
dressing changes every 7 days versus every 3 days
No Intervention: 2
3-days without chlorexidrine impregnated sponge
Device: Chlorhexidine Sponge (Biopatch TM)
dressing with chlorexidrine sponge versus dressing without chlorexidrine sponge
Behavioral: 3-day or 7-day catheter dressing frequency
dressing changes every 7 days versus every 3 days
No Intervention: 4
7 days without chlorexidrine impregnated sponge
Device: Chlorhexidine Sponge (Biopatch TM)
dressing with chlorexidrine sponge versus dressing without chlorexidrine sponge
Behavioral: 3-day or 7-day catheter dressing frequency
dressing changes every 7 days versus every 3 days

  Hide Detailed Description

Detailed Description:

Central venous catheters (CVCs) are often required for the care of patient admitted to the intensive care unit (ICU), and are now indispensable in modern-day medical practice. In the United States, it is estimated that 15 million CVC days occur each year in the ICU , and that approximately 80,000 CVC-associated bloodstream infection (BSIs) occur each year [2]. Data from the NNIS system indicate that approximately 40% of the BSIs are associated with a CVC in the ICU. This definition, however, include CVC-related BSIs (CRBSIs) and primary BSIs. In other multicenter surveys, primary BSIs are the leading cause of BSIs (30-35%), followed by CRBSIs (20-30%), and BSIs originating from pneumonia (20%) .

The attributable mortality of CRBSIs remains debated. It ranges from no increase in mortality in some studies, up to an attributable mortality of 35% in others. In studies adjusting for severity of illness, attributable mortality ranged between 0 and 11.5%. The excess ICU length of stay is estimated 9-12 days.

The cost of CRBSIs is therefore substantial, and efforts are required to reduce the incidence of theses infections. Several publications suggested that multiple strategies should be implemented concomitantly. Besides the critical importance of staff education, technology brings new materials that could decrease the risk for CRBSI. Several studies have demonstrated that antimicrobial- or antiseptic-impregnated CVCs can decrease CRBSIs in the ICU setting. Furthermore, cost-benefit analysis have suggested that the use of impregnated CVCs was beneficial

The recent CDC Guidelines for the prevention of intravascular catheter-related infections recommend the use of antimicrobial- or antiseptic-impregnated CVCs in patients whose CVC is expected to remain in place for more than 5 days, and in ICUs where CRBSI rate remains above the benchmark rates, despite implementing a comprehensive strategy. This restricted recommended use is explained by the concern for emergence of resistance, the risk of adverse effects and the costs of these materials.

CRBSI rates in France could be lower than those observed in the United States. Data from two surveillance networks indicate that the rates of CRBSI range between 1 and 2 CRBSI per 1000 CVC days . Given these low rates, it is not clear that antimicrobial- or antiseptic-impregnated CVCs would be cost-effective.

Since most organisms responsible for CRBSI originate from insertion site in short-term CVC, there was a rationale to try to decrease bacterial colonization at cutaneous insertion site. Among the other new materials under development, a chlorhexidine-impregnated sponge (Biopatch TM), to be placed over the site of catheter insertion, has been proposed. In a prospective, controlled, bicenter, randomized, non blinded study, dressing changes every other day (control group) was compared to dressing changes every 7 days with Biopatch (Biopatch group) (Maki and al., ICAAC 2000). 1,401 lines (either CVCs, peripheral arterial catheters or pulmonary artery catheters) were included in 589 patients. Both groups of patients were comparable. Using proportional hazard models, both CVC colonization and CRBSI were significantly reduced in the Biopatch group, from 29% to 16% (HR, 0.62) for catheter colonization, and from 3.3% to 1.2% (HR, 0.38) for CRBSI.

This study demonstrated a significant reduction of CRBSI using Biopatch. Given the results presented at the ICAAC sessions, there is some concern, however, about the validity of the protective effect of the Biopatch.

Firstly, the intervention group associated Biopatch and the extension of the time between dressing changes, from 2 to 7 days. Preliminary data from cancer patients suggest that time between dressing changes could be extended. In a randomized study, Benhamou et al have recently compared a 4-day to a 15-day catheter-dressing change frequency in children undergoing chemotherapy. They have shown that skin cultures (27 vs 23%) and bloodstream infections (11 vs 13%) rates are not different between the 4-day and the 15-day groups. It is therefore unclear that the reduction of CRBSI observed in the Biopatch group was only due to the Biopatch.

Secondly, the control group in the Maki's study did not use a "placebo", i.e. a sponge not impregnated with chlorhexidine. The study was therefore not blinded for the ICU staff. It is strongly recommended to examine the catheter insertion site daily for local inflammatory signs. Biopatch impede to monitor the insertion site, with a potential for underestimation of local infections signs in these patients. It is possible that daily examination of the insertion site in the control group would conduct to remove the CVC more frequently in these patients, with a potential for higher rate of colonization. In addition, if a study is not blinded, it is useful for the validity of the results that a group of investigators, blinded to the randomized group, review the medical chart to classify catheter infection.

Thirdly, the rate if CRBSI was rather high in the control group (4.45 per 1000 line days). It is not certain that the benefit of Biopatch will be the same in ICUs with lower rates of CRBSI.

The aim of this study is therefore to evaluate the impact of Biopatch, and the impact of dressing changes (every 3 or 7 days) on the reduction of CVC infection

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients older than 18 years
  • with at least a central venous catheter or an arterial catheter
  • whatever the first or subsequent CVC in a same patient
  • in any site of insertion (sub-clavian, jugular or femoral)
  • whatever le CVC is tunnelled or not
  • CVC inserted in the study ICU or immediately before by the intensisvist in the emergency unit or in the operative room,
  • CVC inserted under maximal barrier precautions

Exclusion Criteria:

  • pulmonary artery catheter, haemodialysis/haemodiafiltration CVCs
  • known allergy to chlorhexidine
  • CVC not inserted under maximal barrier precautions
  • Expected duration of CVC for less than 48 hours
  • CVC inserted under emergency conditions
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00417235

Locations
France
grenoble university hospital (medical ICU and surgical ICU)
Grenoble, France, 38043
Saint Joseph Hospital
Paris, France, 75014
University Hospital Beaujon
Paris, France, 75018
University hospital Bichat Claude Bernard
Paris, France, 75018
Sponsors and Collaborators
University Hospital, Grenoble
Ministry of Health, France
Investigators
Principal Investigator: jean-francois Timsit University Hospital, Grenoble
Study Chair: jean-christophe Lucet, MD University hospital Bichat, Paris, France
  More Information

No publications provided by University Hospital, Grenoble

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: TIMSIT, University Hospital of Grenoble
ClinicalTrials.gov Identifier: NCT00417235     History of Changes
Other Study ID Numbers: 05PHN01
Study First Received: December 28, 2006
Last Updated: June 13, 2008
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Grenoble:
catheter related infection
catheter dressing
prevention
Chlorhexidine impregnated dressings
Infection
catheterization

Additional relevant MeSH terms:
Bacteremia
Catheter-Related Infections
Systemic Inflammatory Response Syndrome
Bacterial Infections
Infection
Inflammation
Pathologic Processes
Sepsis
Shock
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents
Anti-Infective Agents, Local
Dermatologic Agents
Disinfectants
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014