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

Primary Purpose

Systemic Inflammatory Response Syndrome, Bacteremia

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Chlorhexidine Sponge (Biopatch TM)
7-day catheter dressing frequency
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Systemic Inflammatory Response Syndrome focused on measuring catheter related infection, catheter dressing, prevention, Chlorhexidine impregnated dressings, Infection, catheterization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • grenoble university hospital (medical ICU and surgical ICU)
  • Saint Joseph Hospital
  • University Hospital Beaujon
  • University hospital Bichat Claude Bernard

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

No Intervention

Experimental

Arm Label

3-days dressing frequency/CHX sponge

7-days dressing frequency/CHX sponge

3-days dressing frequency/No CHX sponge

7-days dressing change/No CHX sponge

Arm Description

Interventions: Device: 'Chlorhexidine Sponge (Biopatch TM)' on the insertion site

Interventions: Behavioural: 7-day catheter dressing frequency Device: 'Chlorhexidine Sponge (Biopatch TM)' on the insertion site

No intervention, classical protocol of dressing frequency every 3-days and no other device

Interventions:Behavioural: 7-day catheter dressing frequency

Outcomes

Primary Outcome Measures

Systemic catheter related sepsis as defined by a blinded expert panels to unmask differences between Chlorhexidine dressings and no Chlorhexidine dressings
Significant catheter culture >=103 cfu/ml for non inferiority between 7 days and 3 day catheter-dressing frequencies

Secondary Outcome Measures

catheter related septicemia
cutaneous allergy
cost

Full Information

First Posted
December 28, 2006
Last Updated
May 23, 2016
Sponsor
University Hospital, Grenoble
Collaborators
Ministry of Health, France
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1. Study Identification

Unique Protocol Identification Number
NCT00417235
Brief Title
Dressing: Frequency of Change and Evaluation of an Antiseptic-Impregnated Catheter Dressing in ICU Patients
Acronym
DRESSING
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
Collaborators
Ministry of Health, France

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Inflammatory Response Syndrome, Bacteremia
Keywords
catheter related infection, catheter dressing, prevention, Chlorhexidine impregnated dressings, Infection, catheterization

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1600 (Actual)

8. Arms, Groups, and Interventions

Arm Title
3-days dressing frequency/CHX sponge
Arm Type
Experimental
Arm Description
Interventions: Device: 'Chlorhexidine Sponge (Biopatch TM)' on the insertion site
Arm Title
7-days dressing frequency/CHX sponge
Arm Type
Experimental
Arm Description
Interventions: Behavioural: 7-day catheter dressing frequency Device: 'Chlorhexidine Sponge (Biopatch TM)' on the insertion site
Arm Title
3-days dressing frequency/No CHX sponge
Arm Type
No Intervention
Arm Description
No intervention, classical protocol of dressing frequency every 3-days and no other device
Arm Title
7-days dressing change/No CHX sponge
Arm Type
Experimental
Arm Description
Interventions:Behavioural: 7-day catheter dressing frequency
Intervention Type
Device
Intervention Name(s)
Chlorhexidine Sponge (Biopatch TM)
Intervention Description
dressing with chlorexidrine sponge versus dressing without chlorexidrine sponge
Intervention Type
Behavioral
Intervention Name(s)
7-day catheter dressing frequency
Intervention Description
dressing changes every 7 days versus every classical change every 3 days
Primary Outcome Measure Information:
Title
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
Title
Significant catheter culture >=103 cfu/ml for non inferiority between 7 days and 3 day catheter-dressing frequencies
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
catheter related septicemia
Time Frame
48 hours
Title
cutaneous allergy
Time Frame
24 hours
Title
cost
Time Frame
within the 60 days after catheter insertion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
jean-francois Timsit
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
jean-christophe Lucet, MD
Organizational Affiliation
University hospital Bichat, Paris, France
Official's Role
Study Chair
Facility Information:
Facility Name
grenoble university hospital (medical ICU and surgical ICU)
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Saint Joseph Hospital
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
University Hospital Beaujon
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
University hospital Bichat Claude Bernard
City
Paris
ZIP/Postal Code
75018
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
32703235
Citation
Buetti N, Ruckly S, Schwebel C, Mimoz O, Souweine B, Lucet JC, Timsit JF. Chlorhexidine-impregnated sponge versus chlorhexidine gel dressing for short-term intravascular catheters: which one is better? Crit Care. 2020 Jul 23;24(1):458. doi: 10.1186/s13054-020-03174-0.
Results Reference
derived
PubMed Identifier
24127770
Citation
Timsit JF, Bouadma L, Mimoz O, Parienti JJ, Garrouste-Orgeas M, Alfandari S, Plantefeve G, Bronchard R, Troche G, Gauzit R, Antona M, Canet E, Bohe J, Herrault MC, Schwebel C, Ruckly S, Souweine B, Lucet JC. Jugular versus femoral short-term catheterization and risk of infection in intensive care unit patients. Causal analysis of two randomized trials. Am J Respir Crit Care Med. 2013 Nov 15;188(10):1232-9. doi: 10.1164/rccm.201303-0460OC.
Results Reference
derived
PubMed Identifier
22488003
Citation
Timsit JF, Bouadma L, Ruckly S, Schwebel C, Garrouste-Orgeas M, Bronchard R, Calvino-Gunther S, Laupland K, Adrie C, Thuong M, Herault MC, Pease S, Arrault X, Lucet JC. Dressing disruption is a major risk factor for catheter-related infections. Crit Care Med. 2012 Jun;40(6):1707-14. doi: 10.1097/CCM.0b013e31824e0d46.
Results Reference
derived
PubMed Identifier
21926570
Citation
Schwebel C, Lucet JC, Vesin A, Arrault X, Calvino-Gunther S, Bouadma L, Timsit JF. Economic evaluation of chlorhexidine-impregnated sponges for preventing catheter-related infections in critically ill adults in the Dressing Study. Crit Care Med. 2012 Jan;40(1):11-7. doi: 10.1097/CCM.0b013e31822f0604.
Results Reference
derived
PubMed Identifier
19318651
Citation
Timsit JF, Schwebel C, Bouadma L, Geffroy A, Garrouste-Orgeas M, Pease S, Herault MC, Haouache H, Calvino-Gunther S, Gestin B, Armand-Lefevre L, Leflon V, Chaplain C, Benali A, Francais A, Adrie C, Zahar JR, Thuong M, Arrault X, Croize J, Lucet JC; Dressing Study Group. Chlorhexidine-impregnated sponges and less frequent dressing changes for prevention of catheter-related infections in critically ill adults: a randomized controlled trial. JAMA. 2009 Mar 25;301(12):1231-41. doi: 10.1001/jama.2009.376.
Results Reference
derived

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

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