Catheter-Related Infections, Central Venous Catheter Exit Site Infection
Conditions
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.
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.
Interventions
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.
DEVICE3M™ 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.
Sponsors
3M
Solventum US LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of CVC Tip Colonization (Positive Catheters After Culture/Total Catheters) | 3-14 days | Rate of CVC tip colonization (positive catheters after culture/total catheters) |
Countries
China
Participant flow
Recruitment details
After 123 subjects were enrolled and completed all the visits, the study was terminated.
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 61 |
| 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.
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. | 62 |
| Total | 123 |
Baseline characteristics
| Characteristic | 3M™ Tegaderm™ CHG I.V. Securement Dressing | Total | 3M™ Tegaderm™ Transparent Film Dressing 1626W |
|---|---|---|---|
| Age, Continuous | 64.5 years STANDARD_DEVIATION 16.84 | 65.4 years STANDARD_DEVIATION 14.94 | 66.4 years STANDARD_DEVIATION 12.88 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 61 Participants | 123 Participants | 62 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment China | 61 participants | 123 participants | 62 participants |
| Sex: Female, Male Female | 18 Participants | 36 Participants | 18 Participants |
| Sex: Female, Male Male | 43 Participants | 87 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 62 | 0 / 61 |
| other Total, other adverse events | 44 / 62 | 46 / 61 |
| serious Total, serious adverse events | 2 / 62 | 0 / 61 |
Outcome results
Primary
Rate of CVC Tip Colonization (Positive Catheters After Culture/Total Catheters)
Rate of CVC tip colonization (positive catheters after culture/total catheters)
Time frame: 3-14 days
Population: This endpoint was not collected for all subjects randomized. Also, the study had major protocol deviations that made the available data unreliable.