CatheterizationPhase 4TegaCHGNCT01142934
Trial on the Efficacy of Tegaderm Chlorhexidine Gluconate (CHG) in Reducing Catheter Related Bloodstream Infections
A Phase 4 study testing Transparent adhesive dressing with an integrated gel pad containing 2% w/w chlorhexidine gluconate (CHG) (TegaDerm CHG) in people with Catheterization and Infection, run by Catholic University of the Sacred Heart at 8 sites in Italy.
Trial summary
TegaCHG is a multicentric randomized study aimed at evaluating the possibility that the use of TegaDerm CHG dressing may reduce the incidence of catheter related blood stream infections (CRBSI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Catheterization, Infection
- What is being tested?
- Transparent adhesive dressing with an integrated gel pad containing 2% w/w chlorhexidine gluconate (CHG) (TegaDerm CHG)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 8 sitesItaly
- Study dates
- Oct 2009to Oct 2012
- 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
- Age ≥ 18 years
- Hospitalized patients, either in Intensive Care Unit or in non-Intensive Care ward settings
- Clinical indication for the insertion of a non-tunneled central venous catheter (excluding large bore catheters for dialysis or pheresis) or a PICC
Who cannot join
- Age < 18 years
- Inability to obtain an informed consent
- Actual evidence - or recent history (< 30 days) - of bloodstream infection
- Central lines inserted in the femoral vein
- Central lines inserted by surgical cutdown
- Use of so called 'treated' catheters, i.e. catheters whose internal and/or external surface is coated with antibacterial drugs as well as catheters whose polyurethane releases ions with potential antiseptic action, should be excluded by the present protocol
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- Specific intolerance or known hypersensitivity to transparent dressings or to chlorhexidine
- Any form of dermatitis, burns, skin lesions or tattoos at the insertion site
- Burns over ≥ 15% of the body surface area
- Use of topical antibiotics within a 10cm of the catheter insertion site
- Enrollment in another investigational drug or device study at any time during this study or 30 days prior.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Italy8 sites, 8 recruiting
- Recruiting
I.C.U. Ospedale Civico
Palermo, PA
Zina Picciuca, RN, zina@ospedalecivicopa.org
Zina Picciuca, RN
- Recruiting
Dpt. Infectious Diseases, Rome Catholic University
Rome, RM, 00168
Giancarlo Scoppettuolo, MD, +393498380576, g.scoppettuolo@rm.unicatt.it
Laura Dolcetti, RN, +393336157080, laura.dolcetti@libero.it
- Recruiting
I.C.U. Rome Catholic University
Rome, RM, 00168
Vincenzo Mencio, RN, vincenzomencio@interfree.it
Vincenzo Mencio, RN
- Recruiting
General Surgery Policlinico Umberto I
Rome, RM
Susanna Sodo, RN, s.sodo@policlinicoumberto1.it
Susanna Sodo, RN
- Recruiting
I.C.U. Heart Surgery Policlinico Umberto I
Rome, RM
Susanna Sodo, RN, s.sodo@policlinicoumberto1.it
Susanna Sodo, RN
- Recruiting
I.C.U. Neurosurgery Policlinico Umberto I
Rome, RM
Susanna Sodo, RN, s.sodo@policlinicoumberto1.it
Susanna Sodo, RN
- Recruiting
I.C.U. Policlinico Umberto I
Rome, RM
Susanna Sodo, RN, s.sodo@policlinicoumberto1.it
- Recruiting
Palliative Car Unit - Ospedale di Circolo
Varese, VA
Daniele Bertollo, MD, dani.fabi@tin.it
Daniele Bertollo, MD
About this study
Official title: A MULTICENTRE RANDOMIZED CONTROLLED CLINICAL TRIAL ON THE EFFICACY OF TEGADERM CHG IN REDUCING CATHETER RELATED BLOOD STREAM INFECTIONS
TegaCHG is a multicentric randomized study aimed at evaluating the possibility that the use of TegaDerm CHG dressing may reduce the incidence of catheter related blood stream infections (CRBSI). It implies the comparison between the incidence of CRBSI in patients with central venous catheter dressed with TegaDerm without chlorhexidine gluconate (CHG) and with CHG. The primary endpoint is the occurrence of CRBSI and the secondary endpoints are:
catheter colonization (growth of microbes from the culture of catheter tip, > 15 CFU according to semi-quantitative method or > 1000 CFU according to quantitative method); incidence of catheter exit site infection; occurrence of catheter related infections/sepsis or other severe infection-related complications; safety profile evaluation: occurrence of hypersensitivity to the dressing on the basis of local objectivity (erythema, edema, other) or on that of patient symptoms (itch, burning sensation); relating to the device performance: incidence of high/medium/low dressing edge lift, ability to visualize the catheter insertion site, easiness of removal, easiness of dressing application; incidence of unscheduled dressing change. The study hypothesis implies that the use of slow release device containing chlorhexidine may decrease the incidence of CRBSI. This has already been showed for chlorhexidine impregnated sponges. Scope of the study is to verify if this property is also true for TegaDerm CHG,which is a new chlorhexidine-releasing dressing in which the medication is directly released by an integrated transparent gel pad, so that the catheter exit site remains visible and easy to inspect without removing the dressing.
- Conditions
- Catheterization, Infection
- Being tested
- Transparent adhesive dressing with an integrated gel pad containing 2% w/w chlorhexidine gluconate (CHG) (TegaDerm CHG)
- Keywords
- Catheter-related bloodstream infections, Chlorhexidine, Transparent dressings
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transparent adhesive dressing with an integrated gel pad containing 2% w/w chlorhexidine gluconate (CHG) (TegaDerm CHG)Device
Also called TegaDerm CHG
The intervention is represented by the combination of the TegaDerm transparent adhesive dressing with an integrated gel pad containing 2% w/w chlorhexidine gluconate (CHG), an antiseptic agent with broad spectrum antimicrobial and antifungal activity.
| Study group | Role | What they receive |
|---|---|---|
| TegaDerm CHG | Other | TegaDerm CHG is the interventional arm to be compared with the control group in which the dressing is TegaDerm (without CHG). Receives: Device: Transparent adhesive dressing with an integrated gel pad containing 2% w/w chlorhexidine gluconate (CHG) (TegaDerm CHG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of catheter-related bloodstream infection
According to the definition of CRBSI suggested in "Clinical practice guidelines for the diagnosis and management of intravascular catheter-related infection: 2009 update by the Infectious Diseases Society of America" (Clin Infect Dis 2009; 49:1-45)
Measured: Up to 7 days after catheter removal
Secondary outcomes (1)
Incidence of adverse events
Other Secondary Outcome Measures are represented by: determining whether TegadermTM CHG decreases catheter colonization; determining whether TegadermTM CHG decreases the incidence of catheter site infection; evaluating patient comfort; to evaluate overall nursing satisfaction (ease of dressing application, incidence of dressing edge lift, ability to visualize the catheter insertion site, ease of removal); determining whether TegadermTM CHG decreases the incidence of unscheduled dressing change compared to the control group.
Measured: Up to 2 days after catheter removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2010 (estimated)
- Study startOct 2009
- Primary completionApr 2012 (estimated)
- Study completionOct 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CatheterizationStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Collaborators
- 3M, Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
- Responsible party
- Principal investigator, Giancarlo Scoppettuolo, Catholic University of the Sacred Heart
- Investigators
- Giancarlo Scoppettuolo, MD, Principal investigator, Dpt. Infectious Diseases, Rome Catholic University (CUSacredHeart)Mauro Pittiruti, MD, Principal investigator, Dpt. Surgery, Rome Catholic University (CUSacredHeart)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01142934
- Sponsor's protocol ID
- TegaCHGit01
- Acronym
- TegaCHG
- Status last verified
- Jan 2012
- First submitted
- 24 May 2010
- Last updated
- 1 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A MULTICENTRE RANDOMIZED CONTROLLED CLINICAL TRIAL ON THE EFFICACY OF TEGADERM CHG IN REDUCING CATHETER RELATED BLOOD STREAM INFECTIONS
- ClinicalTrials.gov ID
- NCT01142934
- Acronym / sponsor ID
- TegaCHG / TegaCHGit01
- Conditions
- Catheterization, Infection
- Keywords
- Catheter-related bloodstream infections, Chlorhexidine, Transparent dressings
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Collaborators
- 3M, Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
- Study start
- Oct 2009
- Primary completion
- Apr 2012 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 14 Jun 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.
TegaCHG is a multicentric randomized study aimed at evaluating the possibility that the use of TegaDerm CHG dressing may reduce the incidence of catheter related blood stream infections (CRBSI). It implies the comparison between the incidence of CRBSI in patients with central venous catheter dressed with TegaDerm without chlorhexidine gluconate (CHG) and with CHG. The primary endpoint is the occurrence of CRBSI and the secondary endpoints are:
catheter colonization (growth of microbes from the culture of catheter tip, > 15 CFU according to semi-quantitative method or > 1000 CFU according to quantitative method); incidence of catheter exit site infection; occurrence of catheter related infections/sepsis or other severe infection-related complications; safety profile evaluation: occurrence of hypersensitivity to the dressing on the basis of local objectivity (erythema, edema, other) or on that of patient symptoms (itch, burning sensation); relating to the device performance: incidence of high/medium/low dressing edge lift, ability to visualize the catheter insertion site, easiness of removal, easiness of dressing application; incidence of unscheduled dressing change. The study hypothesis implies that the use of slow release device containing chlorhexidine may decrease the incidence of CRBSI. This has already been showed for chlorhexidine impregnated sponges. Scope of the study is to verify if this property is also true for TegaDerm CHG,which is a new chlorhexidine-releasing dressing in which the medication is directly released by an integrated transparent gel pad, so that the catheter exit site remains visible and easy to inspect without removing the dressing.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TegaDerm CHG | Other | Device: Transparent adhesive dressing with an integrated gel pad containing 2% w/w chlorhexidine gluconate (CHG) (TegaDerm CHG)TegaDerm CHG is the interventional arm to be compared with the control group in which the dressing is TegaDerm (without CHG). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Hospitalized patients, either in Intensive Care Unit or in non-Intensive Care ward settings
- Clinical indication for the insertion of a non-tunneled central venous catheter (excluding large bore catheters for dialysis or pheresis) or a PICC
Key exclusion criteria (11 listed)
- Age < 18 years
- Inability to obtain an informed consent
- Actual evidence - or recent history (< 30 days) - of bloodstream infection
- Central lines inserted in the femoral vein
- Central lines inserted by surgical cutdown
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 |
|---|---|---|
| Transparent adhesive dressing with an integrated gel pad containing 2% w/w chlorhexidine gluconate (CHG) (TegaDerm CHG)Also: TegaDerm CHGThe intervention is represented by the combination of the TegaDerm transparent adhesive dressing with an integrated gel pad containing 2% w/w chlorhexidine gluconate (CHG), an antiseptic agent with broad spectrum antimicrobial and antifungal activity. | Device | TegaDerm CHG |
Primary outcome
Incidence of catheter-related bloodstream infection
Time frame: Up to 7 days after catheter removal
According to the definition of CRBSI suggested in "Clinical practice guidelines for the diagnosis and management of intravascular catheter-related infection: 2009 update by the Infectious Diseases Society of America" (Clin Infect Dis 2009; 49:1-45)
1 secondary outcome
Incidence of adverse events
Time frame: Up to 2 days after catheter removal
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2012.
- Related InfoLink provided by the sponsor.
- Italian Group for the Study of Medium and Long Term Vascular AccessLink provided by the sponsor.
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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.
Giancarlo Scoppettuolo, MD principal investigator
Dpt. Infectious Diseases, Rome Catholic University (CUSacredHeart)
Mauro Pittiruti, MD principal investigator
Dpt. Surgery, Rome Catholic University (CUSacredHeart)
8 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 Transparent adhesive dressing with an integrated gel pad containing 2% w/w chlorhexidine gluconate (CHG) (TegaDerm CHG) in people with Catheterization and Infection, run by Catholic University of the Sacred Heart at 8 sites in Italy.
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 3 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 1 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giancarlo Scoppettuolo, MD (+393498380576, g.scoppettuolo@rm.unicatt.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of catheter-related bloodstream infection (time frame: Up to 7 days after catheter removal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Feb 2012.