Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00417235
Status:
COMPLETED
Last Update Posted:
2016-05-24
First Post:
2006-12-28
Brief Title:
Dressing Frequency of Change and Evaluation of an Antiseptic-Impregnated Catheter Dressing in ICU Patients
Sponsor:
University Hospital Grenoble
Organization:
University Hospital Grenoble
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2008-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DRESSING
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 80000 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 115 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 1401 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 062 for catheter colonization and from 33 to 12 HR 038 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 Makis study did not use a placebo ie 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 445 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
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 115 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 1401 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 062 for catheter colonization and from 33 to 12 HR 038 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 Makis study did not use a placebo ie 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 445 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None