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

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

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.

Study Overview

• Status: Terminated
• Conditions: Catheter-Related Infections; Central Venous Catheter Exit Site Infection
• Intervention / Treatment: Device: 3M™ Tegaderm™ CHG I.V. Securement Dressing; Device: 3M™ Tegaderm™ Transparent Film Dressing 1626W

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.

• Study Type: Interventional
• Enrollment (Actual): 123
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Ruijin Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Subjects may be included that meet the following criteria:

1. Subjects should be at least 18 years old or older at the time of providing consent;
2. 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;
3. The subject or his/her legally authorized representative should be competent to sign the informed consent form;
4. 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;
5. 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;
6. The patient would comply with the DVC treatment process and the nursing process prescribed in this protocol.

Exclusion Criteria:

Subjects may not be included that meet any of the following criteria:

1. The subject is unwilling/unable to attend study visits (unlike IC);
2. 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;
3. 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;
4. 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;
5. The patient is being or has been subjected to other antibiotic, catheter or skin-related clinical trials;
6. 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;
7. 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;
8. 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;
9. Women who are pregnant or breast feeding;
10. Patients who are not eligible for the study at the discretion of other investigators.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3M™ Tegaderm™ CHG I.V. Securement Dressing; 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.	Device: 3M™ Tegaderm™ CHG I.V. Securement Dressing; 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.
Active Comparator: 3M™ Tegaderm™ Transparent Film Dressing 1626W; 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.	Device: 3M™ Tegaderm™ Transparent Film Dressing 1626W; 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Positive cultured CVC tip cases per 1000 catheters days	number of Positive cultured CVC tip cases per 1000 catheters days	immediately after therapy
Rate of PICCO tip and insertion site colonization (cultured positive case/total catheters, cultured positive case per 1000 catheter days)	Rate of PICCO tip and insertion site colonization (cultured positive case/total catheters, cultured positive case per 1000 catheter days)	immediately after therapy
Rate of hemodialysis catheters tip and insertion site colonization (cultured positive case/total catheters, cultured positive case per 1000 catheter days)	Rate of hemodialysis catheters tip and insertion site colonization (cultured positive case/total catheters, cultured positive case per 1000 catheter days)	immediately after therapy
CLBSI/CLABSI incidence rate	CLBSI/CLABSI incidence rate	immediately after the procedure
Microorganisms type (G+/G-/ candida)	Microorganisms type (G+/G-/ candida)	immediately after therapy
Wear time and change frequency of dressing due to detachment	Wear time and change frequency of dressing due to detachment	immediately after therapy

Collaborators and Investigators

• Sponsor: Solventum US LLC
• Collaborators: 3M
• Investigators: Principal Investigator: Hongping Qu, Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2021
• Primary Completion (Actual): March 31, 2022
• Study Completion (Actual): March 31, 2022

Study Registration Dates

• First Submitted: January 14, 2021
• First Submitted That Met QC Criteria: May 26, 2021
• First Posted (Actual): May 28, 2021

Study Record Updates

• Last Update Posted (Actual): October 16, 2024
• Last Update Submitted That Met QC Criteria: October 14, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Catheter-Related Infections
• Other Study ID Numbers: EM-05-014894

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes