Comparing CHG I.V. Securement Dressing With Transparent Dressing for Evaluation of Antimicrobial ā¦ (NCT04906512) | Clinical Trial Compass
TerminatedNot Applicable
Comparing CHG I.V. Securement Dressing With Transparent Dressing for Evaluation of Antimicrobial Efficacy
Stopped: The decision to terminate this clinical study was made as a cost control measure.
China123 participantsStarted 2021-05-14
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
ā. Subjects should be at least 18 years old or older at the time of providing consent;
ā. 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;
ā. The subject or his/her legally authorized representative should be competent to sign the informed consent form;
ā. 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;
ā. 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;
ā. The patient would comply with the DVC treatment process and the nursing process prescribed in this protocol.
Exclusion criteria
ā. The subject is unwilling/unable to attend study visits (unlike IC);
ā. 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;
ā. 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;
ā. 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;
What they're measuring
1
Rate of CVC Tip Colonization (Positive Catheters After Culture/Total Catheters)
ā. The patient is being or has been subjected to other antibiotic, catheter or skin-related clinical trials;
ā. 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;
ā. 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;
ā. 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;