Catheter-Related InfectionsPhase 4DRESSING2NCT01189682
Impact of Tegaderm HP and CHG in Major Catheter Related Infections and Dressing Detachment
A Phase 4 study testing Tegaderm, Tegaderm HP, Tegaderm CHG in people with Catheter-Related Infections, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Catheter related infection is a frequent and life threatening event in ICU. A chlorhexidine impregnated sponge has been proven to reduce the rate of major catheter related infections in ICU patients (HR=0.39, p=0.03) (Timsit Jama 2009). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Catheter-Related Infections
- What is being tested?
- Tegaderm, Tegaderm HP, Tegaderm CHG
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,960 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2010to Jul 2011
- 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 old with a central venous catheter or arterial catheter installed in the study departement for a maximum for 24 hours
Who cannot join
- pulmonary arterial catheter
- antiseptic-impregnated catheter
- hemodialysis catheter
- chlorhexidine allergy
- emergency catheter without surgical asepsis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Tegaderm HP and Tegaderm CHG in Major Catheter Related Infections and Dressing Detachment in ICU Patients a Prospective Randomized Study
Catheter related infection is a frequent and life threatening event in ICU. A chlorhexidine impregnated sponge has been proven to reduce the rate of major catheter related infections in ICU patients (HR=0.39, p=0.03) (Timsit Jama 2009). However, dressings are detached in 40% of cases before planned changes and the rate of unplanned dressing is significantly associated with the major catheter related infections.
Primary objective: To demonstrate that Tegaderm CHG, a new CHG impregnated dressing decrease the rate of major catheter related infection as compared to non impregnated dressings and to demonstrate that highly adhesive dressing decrease the rate of detached dressings.
Read more
Secondary objectives:
- To demonstrate that the use of high performance dressing decrease the rate of unstuck dressing and the rate of catheter infections.
- To evaluate the tolerance of CHG impregnated gel dressings (Tegaderm CHG).
- To calculate the cost saving of each dressings
Read the detailed description
Inclusion criteria: Patients older than 18 years old with central venous who need a central vein and/or an arterial catheter for an expected duration of more than 48 hours.
- Conditions
- Catheter-Related Infections
- Being tested
- Tegaderm, Tegaderm HP, Tegaderm CHG
- Keywords
- catheter, dressing, chlorhexidine, Patient admitted in ICU with a CVC or art. catheter
- Medical subject headings
- Catheter-Related Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tegaderm, Tegaderm HP, Tegaderm CHGProcedure or surgery
Also called Tegaderm, Tegaderm HP, tegaderm CHG
dressings on catheters
| Study group | Role | What they receive |
|---|---|---|
| Tegaderm HP | Active comparator | Not described Receives: Procedure: Tegaderm, Tegaderm HP, Tegaderm CHG |
| Tegaderm | Placebo comparator | Not described Receives: Procedure: Tegaderm, Tegaderm HP, Tegaderm CHG |
| Tegaderm CHG | Active comparator | Not described Receives: Procedure: Tegaderm, Tegaderm HP, Tegaderm CHG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk of major catheter infection between Group 1 and Group 2+3 assessed by an independent blind expert panel
The patients were followed 48h after catheter removal or discharge. Average follow up of 10 days.
Measured: 48 hours after catheter removal or ICU discharge (10 days on average)
Secondary outcomes (2)
dressing detachment : rate of unplanned dressing between Tegaderm CHG, Tegaderm HP and Tegaderm
Measured: until catheter removal or ICU discharge (8 days on average)
Comparison of Group 1 to group 2+3 : catheter colonization, CR-BSI, cutaneous colonization at catheter removal, cost
Measured: 48 hours after catheter removal or ICU discharge (10 days on average)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2010 (estimated)
- Study startApr 2010
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Catheter-Related InfectionsStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,960 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- TIMSIT Jean-François, PU/PH, Principal investigator, Unit Intensive care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01189682
- Sponsor's protocol ID
- 2009-A01184-53
- Acronym
- DRESSING2
- Status last verified
- Sep 2012
- First submitted
- 25 May 2010
- Last updated
- 21 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Iachkine J, Buetti N, de Grooth HJ, Briant AR, Mimoz O, Megarbane B, Mira JP, Valette X, Daubin C, du Cheyron D, Mermel LA, Timsit JF, Parienti JJ. Development and validation of a multivariable model predicting the required catheter dwell time among mechanically ventilated critically ill patients in three randomized trials. Ann Intensive Care. 2023 Jan 16;13(1):5. doi: 10.1186/s13613-023-01099-9.
PubMed 36645531Iachkine J, Buetti N, de Grooth HJ, Briant AR, Mimoz O, Megarbane B, Mira JP, Ruckly S, Souweine B, du Cheyron D, Mermel LA, Timsit JF, Parienti JJ. Development and validation of a multivariable prediction model of central venous catheter-tip colonization in a cohort of five randomized trials. Crit Care. 2022 Jul 7;26(1):205. doi: 10.1186/s13054-022-04078-x.
PubMed 35799302Buetti 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 32703235Buetti N, Ruckly S, Lucet JC, Bouadma L, Schwebel C, Mimoz O, Timsit JF. Ultrasound guidance and risk for intravascular catheter-related infections among peripheral arterial catheters: a post-hoc analysis of two large randomized-controlled trials. Ann Intensive Care. 2020 Jul 8;10(1):89. doi: 10.1186/s13613-020-00705-4.
PubMed 32643100Maunoury F, Motrunich A, Palka-Santini M, Bernatchez SF, Ruckly S, Timsit JF. Cost-Effectiveness Analysis of a Transparent Antimicrobial Dressing for Managing Central Venous and Arterial Catheters in Intensive Care Units. PLoS One. 2015 Jun 18;10(6):e0130439. doi: 10.1371/journal.pone.0130439. eCollection 2015.
PubMed 26086783Timsit 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, Mimoz O, Mourvillier B, Souweine B, Garrouste-Orgeas M, Alfandari S, Plantefeve G, Bronchard R, Troche G, Gauzit R, Antona M, Canet E, Bohe J, Lepape A, Vesin A, Arrault X, Schwebel C, Adrie C, Zahar JR, Ruckly S, Tournegros C, Lucet JC. Randomized controlled trial of chlorhexidine dressing and highly adhesive dressing for preventing catheter-related infections in critically ill adults. Am J Respir Crit Care Med. 2012 Dec 15;186(12):1272-8. doi: 10.1164/rccm.201206-1038OC. Epub 2012 Oct 4.
PubMed 23043083
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Tegaderm HP and Tegaderm CHG in Major Catheter Related Infections and Dressing Detachment in ICU Patients a Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT01189682
- Acronym / sponsor ID
- DRESSING2 / 2009-A01184-53
- Conditions
- Catheter-Related Infections
- Keywords
- catheter, dressing, chlorhexidine, Patient admitted in ICU with a CVC or art. catheter
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,960 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 27 Aug 2010 (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.
Catheter related infection is a frequent and life threatening event in ICU. A chlorhexidine impregnated sponge has been proven to reduce the rate of major catheter related infections in ICU patients (HR=0.39, p=0.03) (Timsit Jama 2009). However, dressings are detached in 40% of cases before planned changes and the rate of unplanned dressing is significantly associated with the major catheter related infections.
Primary objective: To demonstrate that Tegaderm CHG, a new CHG impregnated dressing decrease the rate of major catheter related infection as compared to non impregnated dressings and to demonstrate that highly adhesive dressing decrease the rate of detached dressings.
Secondary objectives:
- To demonstrate that the use of high performance dressing decrease the rate of unstuck dressing and the rate of catheter infections.
- To evaluate the tolerance of CHG impregnated gel dressings (Tegaderm CHG).
- To calculate the cost saving of each dressings
Detailed description
Inclusion criteria: Patients older than 18 years old with central venous who need a central vein and/or an arterial catheter for an expected duration of more than 48 hours.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tegaderm HP | Active comparator | Procedure: Tegaderm, Tegaderm HP, Tegaderm CHG |
| Tegaderm | Placebo comparator | Procedure: Tegaderm, Tegaderm HP, Tegaderm CHG |
| Tegaderm CHG | Active comparator | Procedure: Tegaderm, Tegaderm HP, Tegaderm CHG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients older than 18 years old with a central venous catheter or arterial catheter installed in the study departement for a maximum for 24 hours
Key exclusion criteria (5 listed)
- pulmonary arterial catheter
- antiseptic-impregnated catheter
- hemodialysis catheter
- chlorhexidine allergy
- emergency catheter without surgical asepsis
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 |
|---|---|---|
| Tegaderm, Tegaderm HP, Tegaderm CHGAlso: Tegaderm, Tegaderm HP, tegaderm CHGdressings on catheters | Procedure or surgery | Tegaderm, Tegaderm CHG, Tegaderm HP |
Primary outcome
Risk of major catheter infection between Group 1 and Group 2+3 assessed by an independent blind expert panel
Time frame: 48 hours after catheter removal or ICU discharge (10 days on average)
The patients were followed 48h after catheter removal or discharge. Average follow up of 10 days.
2 secondary outcomes
dressing detachment : rate of unplanned dressing between Tegaderm CHG, Tegaderm HP and Tegaderm
Time frame: until catheter removal or ICU discharge (8 days on average)
Comparison of Group 1 to group 2+3 : catheter colonization, CR-BSI, cutaneous colonization at catheter removal, cost
Time frame: 48 hours after catheter removal or ICU discharge (10 days on average)
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 21 Oct 2013.
- Derived from this study: PubMed 36645531Iachkine J, Buetti N, de Grooth HJ, Briant AR, Mimoz O, Megarbane B, Mira JP, Valette X, Daubin C, du Cheyron D, Mermel LA, Timsit JF, Parienti JJ. Development and validation of a multivariable model predicting the required catheter dwell time among mechanically ventilated critically ill patients in three randomized trials. Ann Intensive Care. 2023 Jan 16;13(1):5. doi: 10.1186/s13613-023-01099-9.
- Derived from this study: PubMed 35799302Iachkine J, Buetti N, de Grooth HJ, Briant AR, Mimoz O, Megarbane B, Mira JP, Ruckly S, Souweine B, du Cheyron D, Mermel LA, Timsit JF, Parienti JJ. Development and validation of a multivariable prediction model of central venous catheter-tip colonization in a cohort of five randomized trials. Crit Care. 2022 Jul 7;26(1):205. doi: 10.1186/s13054-022-04078-x.
- 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 32643100Buetti N, Ruckly S, Lucet JC, Bouadma L, Schwebel C, Mimoz O, Timsit JF. Ultrasound guidance and risk for intravascular catheter-related infections among peripheral arterial catheters: a post-hoc analysis of two large randomized-controlled trials. Ann Intensive Care. 2020 Jul 8;10(1):89. doi: 10.1186/s13613-020-00705-4.
- Derived from this study: PubMed 26086783Maunoury F, Motrunich A, Palka-Santini M, Bernatchez SF, Ruckly S, Timsit JF. Cost-Effectiveness Analysis of a Transparent Antimicrobial Dressing for Managing Central Venous and Arterial Catheters in Intensive Care Units. PLoS One. 2015 Jun 18;10(6):e0130439. doi: 10.1371/journal.pone.0130439. eCollection 2015.
- 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 23043083Timsit JF, Mimoz O, Mourvillier B, Souweine B, Garrouste-Orgeas M, Alfandari S, Plantefeve G, Bronchard R, Troche G, Gauzit R, Antona M, Canet E, Bohe J, Lepape A, Vesin A, Arrault X, Schwebel C, Adrie C, Zahar JR, Ruckly S, Tournegros C, Lucet JC. Randomized controlled trial of chlorhexidine dressing and highly adhesive dressing for preventing catheter-related infections in critically ill adults. Am J Respir Crit Care Med. 2012 Dec 15;186(12):1272-8. doi: 10.1164/rccm.201206-1038OC. Epub 2012 Oct 4.
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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.
TIMSIT Jean-François, PU/PH principal investigator
Unit Intensive care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tegaderm, Tegaderm HP, Tegaderm CHG in people with Catheter-Related Infections, run by University Hospital, Grenoble at 1 site 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 1 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 21 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
Risk of major catheter infection between Group 1 and Group 2+3 assessed by an independent blind expert panel (time frame: 48 hours after catheter removal or ICU discharge (10 days on average)). 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 NCT01189682, which also lists 7 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 21 Oct 2013.