Systemic Inflammatory Response SyndromePhase 4DRESSINGNCT00417235
Dressing: Frequency of Change and Evaluation of an Antiseptic-Impregnated Catheter Dressing in ICU Patients
A Phase 4 study testing Chlorhexidine Sponge (Biopatch TM) and 7-day catheter dressing frequency in people with Systemic Inflammatory Response Syndrome and Bacteremia, run by University Hospital, Grenoble at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Inflammatory Response Syndrome, Bacteremia
- What is being tested?
- Chlorhexidine Sponge (Biopatch TM) and 7-day catheter dressing frequency
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,600 participants
- Where
- 4 sitesFrance
- Study dates
- Jan 2007to Jun 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
France4 sites
grenoble university hospital (medical ICU and surgical ICU)
Grenoble, 38043
Saint Joseph Hospital
Paris, 75014
University Hospital Beaujon
Paris, 75018
University hospital Bichat Claude Bernard
Paris, 75018
About this study
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
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.
Read the 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
- Being tested
- Chlorhexidine Sponge (Biopatch TM), 7-day catheter dressing frequency
- Keywords
- catheter related infection, catheter dressing, prevention, Chlorhexidine impregnated dressings, Infection, catheterization
- Medical subject headings
- Systemic Inflammatory Response Syndrome, Bacteremia, Catheter-Related Infections, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine Sponge (Biopatch TM)Device
dressing with chlorexidrine sponge versus dressing without chlorexidrine sponge
7-day catheter dressing frequencyBehavioural
dressing changes every 7 days versus every classical change every 3 days
| Study group | Role | What they receive |
|---|---|---|
| 3-days dressing frequency/CHX sponge | Experimental | Interventions:
Device: 'Chlorhexidine Sponge (Biopatch TM)' on the insertion site Receives: Device: Chlorhexidine Sponge (Biopatch TM) |
| 7-days dressing frequency/CHX sponge | Experimental | Interventions:
Behavioural: 7-day catheter dressing frequency Device: 'Chlorhexidine Sponge (Biopatch TM)' on the insertion site Receives: Device: Chlorhexidine Sponge (Biopatch TM); Behavioral: 7-day catheter dressing frequency |
| 3-days dressing frequency/No CHX sponge | No intervention | No intervention, classical protocol of dressing frequency every 3-days and no other device |
| 7-days dressing change/No CHX sponge | Experimental | Interventions:Behavioural: 7-day catheter dressing frequency Receives: Behavioral: 7-day catheter dressing frequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systemic catheter related sepsis as defined by a blinded expert panels to unmask differences between Chlorhexidine dressings and no Chlorhexidine dressings
Measured: 48 hours
Significant catheter culture >=103 cfu/ml for non inferiority between 7 days and 3 day catheter-dressing frequencies
Measured: 48 hours
Secondary outcomes (3)
catheter related septicemia
Measured: 48 hours
cutaneous allergy
Measured: 24 hours
cost
Measured: within the 60 days after catheter insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2006 (estimated)
- Study startJan 2007
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Systemic Inflammatory Response SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,600 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- jean-francois Timsit, Principal investigator, University Hospital, Grenoblejean-christophe Lucet, MD, Study chair, University hospital Bichat, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00417235
- Sponsor's protocol ID
- 05PHN01
- Acronym
- DRESSING
- Status last verified
- Jun 2008
- First submitted
- 28 Dec 2006
- Last updated
- 24 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 32703235Timsit 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.
PubMed 24127770Timsit 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.
PubMed 22488003Schwebel 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.
PubMed 21926570Timsit 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.
PubMed 19318651
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00417235
- Acronym / sponsor ID
- DRESSING / 05PHN01
- Keywords
- catheter related infection, catheter dressing, prevention, Chlorhexidine impregnated dressings, Infection, catheterization
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,600 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Jan 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 29 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 3-days dressing frequency/CHX sponge | Experimental | Device: Chlorhexidine Sponge (Biopatch TM)Interventions: Device: 'Chlorhexidine Sponge (Biopatch TM)' on the insertion site |
| 7-days dressing frequency/CHX sponge | Experimental | Device: Chlorhexidine Sponge (Biopatch TM), Behavioral: 7-day catheter dressing frequencyInterventions: Behavioural: 7-day catheter dressing frequency Device: 'Chlorhexidine Sponge (Biopatch TM)' on the insertion site |
| 3-days dressing frequency/No CHX sponge | No intervention | –No intervention, classical protocol of dressing frequency every 3-days and no other device |
| 7-days dressing change/No CHX sponge | Experimental | Behavioral: 7-day catheter dressing frequencyInterventions:Behavioural: 7-day catheter dressing frequency |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chlorhexidine Sponge (Biopatch TM)dressing with chlorexidrine sponge versus dressing without chlorexidrine sponge | Device | 3-days dressing frequency/CHX sponge, 7-days dressing frequency/CHX sponge |
| 7-day catheter dressing frequencydressing changes every 7 days versus every classical change every 3 days | Behavioural | 7-days dressing change/No CHX sponge, 7-days dressing frequency/CHX sponge |
Primary outcome
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
Significant catheter culture >=103 cfu/ml for non inferiority between 7 days and 3 day catheter-dressing frequencies
Time frame: 48 hours
3 secondary outcomes
catheter related septicemia
Time frame: 48 hours
cutaneous allergy
Time frame: 24 hours
cost
Time frame: within the 60 days after catheter insertion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2016.
- Derived from this study: PubMed 32703235Buetti 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.
- Derived from this study: PubMed 24127770Timsit 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.
- Derived from this study: PubMed 22488003Timsit 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.
- Derived from this study: PubMed 21926570Schwebel 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.
- Derived from this study: PubMed 19318651Timsit 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
jean-francois Timsit principal investigator
University Hospital, Grenoble
jean-christophe Lucet, MD study chair
University hospital Bichat, Paris, France
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Chlorhexidine Sponge (Biopatch TM) and 7-day catheter dressing frequency in people with Systemic Inflammatory Response Syndrome and Bacteremia, run by University Hospital, Grenoble at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00417235, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2016.