NCT04906512

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: Solventum US LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2021-05-14
• Primary completion: 2022-03-31
• Completion: 2022-03-31
• First posted: 2021-05-28
• Last updated: 2024-10-16
• Results posted: 2023-10-06

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated device study