Status:
TERMINATED
Comparing CHG I.V. Securement Dressing With Transparent Dressing for Evaluation of Antimicrobial Efficacy
Lead Sponsor:
Solventum US LLC
Collaborating Sponsors:
3M
Conditions:
Central Venous Catheter Exit Site Infection
Catheter-Related Infections
Eligibility:
All Genders
18+ years
Phase:
NA
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 ve...
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 Te...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
May 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2022
Estimated Enrollment :
123 Patients enrolled
Trial Details
Trial ID
NCT04906512
Start Date
May 14 2021
End Date
March 31 2022
Last Update
October 16 2024
Active Locations (1)
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1
Ruijin Hospital
Shanghai, Shanghai Municipality, China