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

NCT04906512 | Terminated Results FDA Device

• 1 other identifier: EM-05-014894
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Central Venous Catheter Exit Site Infection; Catheter-Related Infections

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

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.

Device: 3M™ Tegaderm™ Transparent Film Dressing 1626W

Interventions

3M™ Tegaderm™ CHG I.V. Securement Dressing DEVICE

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™ CHG I.V. Securement Dressing

3M™ Tegaderm™ Transparent Film Dressing 1626W DEVICE

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 1626W

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Solventum US LLC: lead
• 3M: collaborator

Study Sites (1)

Ruijin Hospital

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Catheter-Related Infections

Condition Hierarchy (Ancestors)

Infections

Results Point of Contact

• Title: Dr. Hongping Qu
• Organization: Ruijin Hospital

rjhcrc@126.com

021-64370045

Study Officials

• Hongping Qu

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: May 28, 2021
• Study Start: May 14, 2021
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: October 16, 2024
• Results First Posted: October 6, 2023

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)