Central Venous Catheter Exit Site InfectionNCT04906512

Comparing CHG I.V. Securement Dressing With Transparent Dressing for Evaluation of Antimicrobial Efficacy

A study testing 3M™ Tegaderm™ CHG I.V. Securement Dressing and 3M™ Tegaderm™ Transparent Film Dressing 1626W in people with Central Venous Catheter Exit Site Infection and Catheter-Related Infections, run by Solventum US LLC at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This is a single-center, prospective, randomized controlled clinical trial designed to compare the antimicrobial efficacy of Tegaderm CHG I.V. Securement Dressing and transparent dressings for deep vein catheterization in adult ICU patients. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Central Venous Catheter Exit Site Infection, Catheter-Related Infections
What is being tested?: 3M™ Tegaderm™ CHG I.V. Securement Dressing and 3M™ Tegaderm™ Transparent Film Dressing 1626W
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 123 participants
Where: 1 siteChina
Study dates: 14 May 2021to 31 Mar 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Subjects may be included that meet the following criteria:
Subjects should be at least 18 years old or older at the time of providing consent;
Subjects would be available to attend all visits required in the trial, be inpatients in the Department of Critical Care Medicine and have an expected length of stay in the ICU of no less than 3 days;
The subject or his/her legally authorized representative should be competent to sign the informed consent form;
The patient must have a central venous catheter (CVC) used on him/her, which may or may not be used in combination with other types of DVCs;
The patient's catheter insertion site is free of deformities, phlebitis, infiltrations, dermatitis, eczema, rashes, breaks, burns, tattoos or other skin conditions that may affect the integrity of the skin at the insertion site;
The patient would comply with the DVC treatment process and the nursing process prescribed in this protocol.

Who cannot join

Subjects may not be included that meet any of the following criteria:
The subject is unwilling/unable to attend study visits (unlike IC);
There is sunburn, skin infection or scar, mole or other blemishes on the subject's catheterization site that would affect the scoring or measurement of the site;
The patient is assessed by the investigator as being at high risk of CLABSI, or known to be CLABSI, based on the environment, duration, and site conditions of catheterization;
The patient is documented or known to have allergies (sensitivities) to adhesive products, or other products involved in the trial, e.g. transparent dressings, CHG and alcohol;
The patient is being or has been subjected to other antibiotic, catheter or skin-related clinical trials;

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The patient needs topical application of creams containing antimicrobial ingredients or other antimicrobial fluids beneath the Tegaderm CHG dressing or transparent dressing for skin disinfection, in addition to the requirements of this protocol;
The patient is assessed by the investigator as being at high risk of blood stream infection, or known to be sepsis, caused by blood stream infection;
The patient has dermatitis, burns, lesions, breaks, eczema, tattoos or other conditions at the catheter insertion site that would interfere with observation in the trial;
Women who are pregnant or breast feeding;
Patients who are not eligible for the study at the discretion of other investigators.

Trial locations and contacts

1 site in 1 country.

China1 site

Ruijin Hospital
Shanghai, Shanghai Municipality

Other trials in China

About this study

Official title: A Randomized Perspective, Open and Parallel Controlled Study Comparing 3M Tegaderm CHG I.V. Securement Dressing With 3M Tegaderm Transparent Dressing for Evaluation of Antimicrobial Efficacy on DVC Insertion Site in Adult in Critical Care

Read the detailed description

This clinical trial is designed as a prospective, randomized, open-label, parallel-group controlled trial.

Investigational product: 3M™ Tegaderm™ CHG I.V. Securement Dressing Control product: 3MTM TegadermTM Transparent Film Dressing 1626W

Considering the easy-to-distinguish appearances of both products used, this trial will adopt an open-label design. The primary endpoint is the rate of CVC tip colonization (positive catheters after culture/total catheters).

Subjects eligible for enrollment will be randomly assigned to either the Tegaderm CHG dressing group or the transparent dressing group, and patients in both groups will be given catheterization according to the hospital's standards and nursed according to the catheter maintenance procedure. The investigator would monitor the subjects during dressing changes, observing the subjects' general conditions, skin condition at the DVC site and the dressing condition, and change a dressing or take relevant measures (if applicable), until the end of the trial, i.e. CVC removal or patient transfer out of the ICU.

440 subjects who meet the inclusion/exclusion criteria will be enrolled. Subjects will be adult voluntary clinical subjects, of either sex, at least 18 years of age, who are ICU patients undergoing deep venous catheterization (DVC), in which a CVC catheter must be used while other types of catheters such as hemodialysis, PICCO, and floating catheters may be used concurrently.

Conditions: Central Venous Catheter Exit Site Infection, Catheter-Related Infections
Being tested: 3M™ Tegaderm™ CHG I.V. Securement Dressing, 3M™ Tegaderm™ Transparent Film Dressing 1626W
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.

3M™ Tegaderm™ CHG I.V. Securement DressingDevice
Subjects eligible for enrollment will be randomly assigned to either the Tegaderm CHG dressing group or the transparent dressing group, and patients in both groups will be given catheterization according to the hospital's standards and nursed according to the catheter maintenance procedure. The investigator would monitor the subjects during dressing changes, observing the subjects' general conditions, skin condition at the DVC site and the dressing condition, and change a dressing or take relevant measures (if applicable), until the end of the trial, i.e. CVC removal or patient transfer out of the ICU.
3M™ Tegaderm™ Transparent Film Dressing 1626WDevice
Subjects eligible for enrollment will be randomly assigned to either the Tegaderm CHG dressing group or the transparent dressing group, and patients in both groups will be given catheterization according to the hospital's standards and nursed according to the catheter maintenance procedure. The investigator would monitor the subjects during dressing changes, observing the subjects' general conditions, skin condition at the DVC site and the dressing condition, and change a dressing or take relevant measures (if applicable), until the end of the trial, i.e. CVC removal or patient transfer out of the ICU.

Study groups in NCT04906512
Study group	Role	What they receive
3M™ Tegaderm™ CHG I.V. Securement Dressing	Experimental	The primary purpose of 3M™ Tegaderm™ CHG I.V. Securement Dressing is to secure devices to skin; and secondly, the dressing contains an antimicrobial ingredient that inhibits microbial regeneration. This product is used to cover and protect the catheter sites on the body surface and to secure devices to skin and is available in a variety of models and sizes. Receives: Device: 3M™ Tegaderm™ CHG I.V. Securement Dressing
3M™ Tegaderm™ Transparent Film Dressing 1626W	Active comparator	Transparent dressing, i.e. CHG-free transparent dressing, can be used to cover and protect catheter sites on the body surface and to secure devices to skin, without any antibacterial ingredients, and are the currently most commonly used transparent dressings in DVC care in China. Receives: Device: 3M™ Tegaderm™ Transparent Film Dressing 1626W

What is being measured

The primary outcome is the main question the study is designed to answer.

Rate of CVC Tip Colonization (Positive Catheters After Culture/Total Catheters)
Rate of CVC tip colonization (positive catheters after culture/total catheters)
Measured: 3-14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 May 202131 Mar 2022

First posted28 May 2021
Study start14 May 2021
Primary completion31 Mar 2022
Study completion31 Mar 2022

Why it stopped: The decision to terminate this clinical study was made as a cost control measure.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Central Venous Catheter Exit Site InfectionStudies 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 N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 123 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04906512
Sponsor's protocol ID: EM-05-014894
Status last verified: Oct 2024
First submitted: 14 Jan 2021
Last updated: 16 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Perspective, Open and Parallel Controlled Study Comparing 3M Tegaderm CHG I.V. Securement Dressing With 3M Tegaderm Transparent Dressing for Evaluation of Antimicrobial Efficacy on DVC Insertion Site in Adult in Critical Care
ClinicalTrials.gov ID: NCT04906512
Acronym / sponsor ID: EM-05-014894
Conditions: Central Venous Catheter Exit Site Infection, Catheter-Related Infections
Study type: Interventional
Recruitment status: TerminatedReason stopped: The decision to terminate this clinical study was made as a cost control measure.
Enrolment: 123 participants (actual)
Lead sponsor: Solventum US LLCIndustry (pharma, biotech, devices)
Collaborators: 3M
Study start: 14 May 2021 (actual)
Primary completion: 31 Mar 2022 (actual)
Study completion: 31 Mar 2022 (actual)
First posted: 28 May 2021 (actual)
Results: Posted 6 Oct 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This clinical trial is designed as a prospective, randomized, open-label, parallel-group controlled trial.

Investigational product: 3M™ Tegaderm™ CHG I.V. Securement Dressing Control product: 3MTM TegadermTM Transparent Film Dressing 1626W

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
3M™ Tegaderm™ CHG I.V. Securement Dressing	Experimental	Device: 3M™ Tegaderm™ CHG I.V. Securement DressingThe primary purpose of 3M™ Tegaderm™ CHG I.V. Securement Dressing is to secure devices to skin; and secondly, the dressing contains an antimicrobial ingredient that inhibits microbial regeneration. This product is used to cover and protect the catheter sites on the body surface and to secure devices to skin and is available in a variety of models and sizes.
3M™ Tegaderm™ Transparent Film Dressing 1626W	Active comparator	Device: 3M™ Tegaderm™ Transparent Film Dressing 1626WTransparent dressing, i.e. CHG-free transparent dressing, can be used to cover and protect catheter sites on the body surface and to secure devices to skin, without any antibacterial ingredients, and are the currently most commonly used transparent dressings in DVC care in China.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Subjects should be at least 18 years old or older at the time of providing consent;
Subjects would be available to attend all visits required in the trial, be inpatients in the Department of Critical Care Medicine and have an expected length of stay in the ICU of no less than 3 days;
The subject or his/her legally authorized representative should be competent to sign the informed consent form;
The patient must have a central venous catheter (CVC) used on him/her, which may or may not be used in combination with other types of DVCs;
The patient's catheter insertion site is free of deformities, phlebitis, infiltrations, dermatitis, eczema, rashes, breaks, burns, tattoos or other skin conditions that may affect the integrity of the skin at the insertion site;

Key exclusion criteria (11 listed)

The subject is unwilling/unable to attend study visits (unlike IC);
There is sunburn, skin infection or scar, mole or other blemishes on the subject's catheterization site that would affect the scoring or measurement of the site;
The patient is assessed by the investigator as being at high risk of CLABSI, or known to be CLABSI, based on the environment, duration, and site conditions of catheterization;
The patient is documented or known to have allergies (sensitivities) to adhesive products, or other products involved in the trial, e.g. transparent dressings, CHG and alcohol;
The patient is being or has been subjected to other antibiotic, catheter or skin-related clinical trials;

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
3M™ Tegaderm™ CHG I.V. Securement DressingSubjects eligible for enrollment will be randomly assigned to either the Tegaderm CHG dressing group or the transparent dressing group, and patients in both groups will be given catheterization according to the hospital's standards and nursed according to the catheter maintenance procedure. The investigator would monitor the subjects during dressing changes, observing the subjects' general conditions, skin condition at the DVC site and the dressing condition, and change a dressing or take relevant measures (if applicable), until the end of the trial, i.e. CVC removal or patient transfer out of the ICU.	Device	3M™ Tegaderm™ CHG I.V. Securement Dressing
3M™ Tegaderm™ Transparent Film Dressing 1626WSubjects eligible for enrollment will be randomly assigned to either the Tegaderm CHG dressing group or the transparent dressing group, and patients in both groups will be given catheterization according to the hospital's standards and nursed according to the catheter maintenance procedure. The investigator would monitor the subjects during dressing changes, observing the subjects' general conditions, skin condition at the DVC site and the dressing condition, and change a dressing or take relevant measures (if applicable), until the end of the trial, i.e. CVC removal or patient transfer out of the ICU.	Device	3M™ Tegaderm™ Transparent Film Dressing 1626W

Primary outcome

Rate of CVC Tip Colonization (Positive Catheters After Culture/Total Catheters)
Time frame: 3-14 days
Rate of CVC tip colonization (positive catheters after culture/total catheters)

Results and safety

Results posted to the registry on 6 Oct 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
3M™ Tegaderm™ Transparent Film Dressing 1626W	62	39
3M™ Tegaderm™ CHG I.V. Securement Dressing	61	42

Primary outcome: Rate of CVC Tip Colonization (Positive Catheters After Culture/Total Catheters)

Time frame: 3-14 days

Population analysed: This endpoint was not collected for all subjects randomized. Also, the study had major protocol deviations that made the available data unreliable.

Adverse events

Time frame: 3-14 days. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
3M™ Tegaderm™ Transparent Film Dressing 1626W	2 of 62 (3.2%)	44 of 62 (71%)	2 of 62
3M™ Tegaderm™ CHG I.V. Securement Dressing	0 of 61 (0%)	46 of 61 (75.4%)	0 of 61

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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.

Hongping Qu principal investigator

Ruijin Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 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: stopped early, as of the sponsor's last update on 16 Oct 2024. 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 China. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Rate of CVC Tip Colonization (Positive Catheters After Culture/Total Catheters) (time frame: 3-14 days). 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 NCT04906512.

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 16 Oct 2024.