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
Phase: NA
Conditions: Central Venous Catheter Exit Site Infection, Catheter-Related Infections
Sponsor: Solventum US LLC

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Study Title 
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 
Study Number 
EM-05-014894 
Release Date 
04/05/2021 11:40:57 PM CDT 
Name of Device Under 
Investigation 
3M Tegaderm CHG I.V. Securement Dressings 
Sponsor Address 
3M China 
Manufacturer 
Address 
3M Company  
 
 
ELECTRONIC SIGNATURES: 
Signer 
Role 
Date Signed 
<<System generated - Do not type in this 
table>> 
 
 
 
3M Confidential 
This document contains confidential information that is the property of 3M and is 
subject to all the restrictions on its use and disclosure contained in the study contract 
to which this is appended. Do not copy, disclose, circulate or use for benefit for any 
third party without written authorization from 3M. 
NCT #: NCT04906512

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Investigator Statement 
Statements of Compliance  
This clinical investigation shall be conducted in accordance with the ethical principles that 
have their origin in the Declaration of Helsinki. 
This clinical investigation shall be conducted in accordance with ISO-14155:2011 and 
future versions, US FDA 21 CFR parts 812, 50, 54, 56, and any regional or national 
regulations, as appropriate.  
The clinical investigation shall not begin until the required approval/favorable opinion from 
the Institutional Review Board (IRB)/Ethics Committee (EC) and regulatory authority (if 
applicable) has been obtained and permission to proceed has been received from the study 
Sponsor.  Any additional requirements imposed by the IRB/EC or regulatory authority shall 
be followed.   
I have read the Clinical Investigation Plan (CIP), including all appendices, as well as 
supporting study related documents and I agree that it contains all necessary details for me 
and my staff to conduct this study as described. I agree to record all adverse events/ 
deviations and report those adverse events/ deviations to the Sponsor per this CIP and 
IRB/EC per local requirements.  I always agree to maintain product accountability and 
ensure security of study materials. I agree to comply with financial disclosure requirements. 
All subjects will sign and date the approved Informed Consent before any study procedures 
are conducted, as applicable 
I will ensure that all subjects meet inclusion criteria before enrolling them in the study. 
I agree to maintain and retain records as required by this Clinical Investigation Plan. 
Investigator’s Signature: 
 
Investigator’s Name: 
Hongping Qu 
Institution: 
Shanghai Ruijin Hospital 
Date of Signature: 
 
 

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TABLE OF CONTENTS 
1.0 SYNOPSIS ......................................................................................................................... 6 
2.0 BACKGROUND AND JUSTIFICATION...................................................................... 11 
2.1 
Description of Study Device 
12 
3.0 STUDY DEVICE INFORMATION................................................................................ 12 
Trial product 
12 
Working principle: ............................................................................................................ 12 
Product model:  1657R, 1658R, 1659R, 1660R ............................................................... 13 
Product usage .................................................................................................................... 13 
Indications ......................................................................................................................... 13 
Contraindications .............................................................................................................. 13 
Warning............................................................................................................................. 13 
Precautions ........................................................................................................................ 13 
Control product 
14 
Working principle ............................................................................................................. 14 
Product features ................................................................................................................ 14 
Product usage .................................................................................................................... 14 
Indications ......................................................................................................................... 14 
Contraindications .............................................................................................................. 14 
Precautions ........................................................................................................................ 14 
3.1 
Device Regulatory Classification 
15 
3.2 
Intended Use of Device 
15 
3.3 
Risks and Benefits of the Device(s) Used in this Study 
16 
3.3.1 
Risks of the Device .............................................................................................. 16 
3.3.2 
Anticipated Adverse Device Effects .................................................................... 16 
3.3.3 
Residual Risks ...................................................................................................... 17 
3.3.4 
Risk of Interactions with Concomitant Medical Treatments ............................... 17 
3.3.5 
Mitigation of Risk ................................................................................................ 17 
3.3.6 
Benefits of the Device .......................................................................................... 18 
3.3.7 
Risk to Benefit Rationale ..................................................................................... 18 
4.0 DESIGN OF CLINICAL INVESTIGATION ................................................................. 18 
4.1 
Design 
18 
4.1.1 
Scientific Rationale for Design ............................................................................ 18 
4.1.2 
Minimization of Bias ........................................................................................... 18 
5.0 OBJECTIVES OF THE CLINICAL INVESTIGATION PLAN .................................... 19 
5.1 
Primary Objective(s) 
19 
5.2 
Secondary Objective(s) 
19 
5.3 
Endpoint(s) 
20 
5.3.1 
Primary Endpoint(s) ............................................................................................. 20 
5.3.2 
Secondary Endpoint(s) ......................................................................................... 20 
6.0 POPULATION AND DURATION ................................................................................. 21 
7.0 ENROLLMENT CRITERIA ........................................................................................... 21 
7.1 
Inclusion Criteria 
21 

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7.2 
Exclusion Criteria 
22 
8.0 INFORMED CONSENT PROCESS ............................................................................... 22 
9.0 POINT OF ENROLLMENT AND EXIT ........................................................................ 23 
9.1 
Point of Enrollment 
23 
9.2 
Point of Exit 
24 
10.0 PROCEDURES................................................................................................................ 24 
10.1 
Procedure Diagram 
24 
10.2 
Visits 
26 
10.2.1 
Randomization .............................................................................................. 26 
10.2.2 
Visit 1/Enrollment Visit/Baseline Visit (Study Day 0)................................. 26 
10.2.3 
Follow-up visits (number of visits to be marked if there are multiple visits 
during each dressing change) ............................................................................................ 27 
10.2.4 
End-of-treatment Visit .................................................................................. 28 
10.3 
Schedule of Events 
29 
11.0 SAFETY AND EVENT REPORTING ........................................................................... 30 
11.1 
Safety Oversight – Sponsor 
30 
11.2 
Safety Recording and Reporting Requirements – Investigator 
31 
11.3 
Safety and Event Reporting Definitions 
31 
11.3.1 
Severity Ratings ............................................................................................ 32 
11.3.2 
Relatedness ................................................................................................... 32 
11.4 
Safety and Event Sponsor Reporting Requirements 
33 
11.4.1 
Reporting Timelines...................................................................................... 34 
12.0 DEVIATIONS ................................................................................................................. 35 
12.1 
Deviation Reporting Timelines 
35 
13.0 PREMATURE STUDY TERMINATION ...................................................................... 35 
14.0 MONITORING ................................................................................................................ 36 
15.0 ROLE OF SPONSOR REPRESENTATIVE................................................................... 38 
16.0 DEVICE ACCOUNTABILITY....................................................................................... 38 
16.1 
Device Labeling 
38 
16.2 
Additional Study-Specific Equipment/Device(s) 
38 
17.0 CONFIDENTIALITY...................................................................................................... 39 
17.1 
Future Use of Stored Collected Specimens 
39 
18.0 DATA HANDLING AND RECORD KEEPING ........................................................... 40 
18.1 
Data Collection and Management Responsibilities 
40 
18.2 
Study Records Retention 
40 
18.3 
Sponsor Oversight 
41 
19.0 STATISTICAL CONSIDERATIONS............................................................................. 41 
19.1 
Statistical Hypotheses 
41 
19.2 
Sample Size Determination 
41 
19.3 
Population for Analyses 
42 
19.4 
Statistical Analyses 
42 
19.5 
Planned Interim Analyses and Criteria for Clinical Investigation 
43 
19.6 
Procedures for Missing, Unused or Spurious Data 
43 

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19.7 
Procedures for Reporting Deviations from Statistical Plan 
43 
19.8 
Validation Plan 
43 
20.0 CONFLICT OF INTEREST ............................................................................................ 43 
21.0 CLINICAL INVESTIGATION PLAN MODIFICATIONS ........................................... 44 
22.0 PERIODIC REVIEWS .................................................................................................... 44 
23.0 INSURANCE ................................................................................................................... 44 
24.0 PUBLIC REGISTRATION AND PUBLICATION ........................................................ 45 
25.0 BIBLIOGRAPHY ............................................................................................................ 45 
26.0 GLOSSARY .................................................................................................................... 46 
27.0 STUDY-SPECIFIC APPENDICES................................................................................. 47 
 

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1.0 
SYNOPSIS 
Study Title 
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 
Study Type 
post-market 
Principal 
Investigator (PI) 
Name: Hongping Qu 
Title:  Professor 
Site: Ruijin Hospital Critical Care Department 
Device under 
Investigation 
Summary 
3M Tegaderm CHG I.V. Securement Dressings 
This product is composed of a transparent dressing and a gel pad. 
The gel pad contains 2% (w/w) chlorhexidine gluconate (CHG), 
which is an antimicrobial agent. This product is suitable for covering 
and protecting catheter sites (including arterial and venous catheters, 
intravascular catheters, and percutaneous devices) on the body 
surface and securing devices to healthy skin. This product should not 
be used on infected wounds or unhealthy skins. 
Sponsor 
3M China 
Purpose 
The objective of this study is to evaluate the antimicrobial efficacy 
of Tegaderm CHG dressing on DVC insertion site in adult patients 
in critical care  
Design 
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. 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 

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applicable), until the end of the trial, i.e. CVC removal or patient 
transfer out of the ICU. 
Selection of 
Subjects 
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.   
 
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);  

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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. 
Device Regulatory 
Classification 
The test device is imported Class II medical device with the license 
of GXZJ No.20163642045. The control device is imported Class II 
medical device with the license of GXZJ No.20182642129.  Both 
have been registered in China.  

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Primary 
Objective(s) 
The primary objective of this study is compare the difference in the 
bacterial colonization rate at the CVC tip and the catheterization site 
on the skin after removal (number of culture-positive cases/total 
catheters × 100%) between the test and control groups 
Secondary 
Objective(s) 
The secondary objective of this study is to compare the differences in 
the following indicators between the test and control groups:  
 
Number of positive cases per 1,000 catheter-days of bacterial 
colonization at CVC tips  
 
Bacterial colonization rate at the tip of other types of 
(percutaneous) deep vein catheters and the catheterization site 
(number of culture positive cases/total catheters x 100% and 
number of positive cases per 1,000 catheter-days), including 
hemodialysis, PICCO, float catheters, etc.  
 
Incidence rate of Central Line Associated Bloodstream 
Infections (CLABSI) or Catheter Related Blood Stream 
Infections (CRBSI)  
 
Type of pathogenic microorganism (G+/G-/fungal or specific 
species, drug-resistant bacteria, etc.) and percentage of positivity 
 
Securement performance of the dressing: Frequency of dressing 
changes associated with wear time and lift or drop-off 
 
Effects on the skin of the covered area, e.g. local infection, local 
skin irritation  
Endpoint(s) 
The primary endpoint is the removal of the CVC from the patient 
with deep vein catheterization to perform catheter-tip culture and 
sampling and culture of bacteria from the skin around the insertion 
site.  
Secondary endpoints  
1. Removal of other types of DVCs, such as hemodialysis and 
PICCO to perform catheter-tip culture and sampling and culture 
of bacteria from skin around the insertion site;  
2. Occurrence of suspected CLABSI/CRBSI, performing catheter-
tip culture and blood bacterial culture;  

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3. Dressing securement performance, such as lift or drop-off;  
4. Safety indicators, mainly referring to the effect of the dressing 
on the state of the skin. 
Randomization 
Subjects are randomly assigned to test device group or control 
device group 
Duration of the 
Study 
The duration of the study is anticipated to be 15 months from First 
Subject In to Last Subject Out. 
The duration of each study subject’s participation will be 3-14 days, 
depending on the subject's disease treatment schedule, each study 
subject would be treated with the same CVC for essentially no more 
than 2 weeks 
Sponsor Study 
Contact 
Name: Yang Ye 
Address: 222 Tianlin Road, Xuhui District, Shanghai 
Telephone: 18018588001 
Email:  yye2@mmm.com 
Medical Monitor 
Contact 
Name: Matthew Cooper, MD MBA FACS 
Address: 3M US 
Telephone: +16517364689 
Email:  mmcooper2@mmm.com 

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2.0 
BACKGROUND AND JUSTIFICATION 
Use of deep venous catheters (DVC) in ICU patients, such as central venous catheters 
(CVC), pulse index continuous cardiac output (PICCO) catheters and hemodialysis catheters is 
associated with a high risk of bloodstream infections. It is estimated that approximately 3-5% 
of catheterization processes would trigger catheter-related bloodstream infections CRBSI1 
(Moureau et al, 2009). The World Health Organization (WHO), the National Institute for 
Clinical Excellence (NICE) and the Centers for Disease Control (CDC) all recommend the use 
of chlorhexidine-impregnated dressings to reduce the risk of CRBSI. Several clinical trials have 
proved the clinical efficacy of chlorhexidine-impregnated dressings in reducing CRBSI and/or 
CLABSI. 2,3,4 
The patient's skin flora is one of the main sources of microbial pathogens, and 
microorganisms can migrate from the CVC insertion site along the outer surface of the catheter 
and hematogenously spread from other infected sites or contaminated infusion sites, 
contaminating the center of the catheter and resulting in bacterial colonization10,11. CHG-
impregnated dressings can maintain low skin microbial counts at the securement site during 
use. CHG has long been used as a skin disinfectant and antimicrobial agent, but challenges have 
arisen as the skin microbiota begins to regenerate a few hours after disinfection. A study12 
shows that Tegaderm CHG dressing significantly reduced the number of microorganisms at the 
CVC insertion site, suture site and catheter colonization. Several studies have demonstrated that 
the use of Tegaderm CHG dressings facilitates easy visualization of the catheterization site and 
that the risk of adverse skin reactions is no higher than existing comparable products5-9. In 
addition, the NICE's advisory committee has concluded that Tegaderm CHG dressings offer 
greater finished product benefits compared to chlorhexidine-free dressings.  
Tegaderm CHG Dressing is used to cover and protect the catheterization site on the body 
surface and to secure devices to skin. Tegaderm CHG Dressing is indicated to reduce skin 
bacterial colonization and catheter bacterial colonization, inhibit microbial regeneration, and 
reduce the rate of central catheter-related bloodstream infections (CRBSI). Tegaderm CHG 
Dressing consists of a transparent dressing and a gel pad. The gel pad contains 2% (w/w) 
chlorhexidine gluconate (CHG). CHG is a classical germicide with broad-spectrum 
antibacterial and antifungal activity. The transparent dressing acts as a barrier to protect the 
venipuncture site, effectively blocking external contamination, including fluids (waterproof), 
bacteria, virus and fungi. In vitro tests have demonstrated that the Tegaderm CHG gel pad in 
the dressing can inhibit a wide range of Gram-positive/negative bacteria and yeasts. Tegaderm 
CHG dressings are transparent for continuous observation of the puncture site and are 
breathable to allow moisture to escape.  

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Although many studies support the clinical efficacy of Tegaderm CHG dressing in 
reducing skin and catheter bacterial colonization, to our knowledge, no similar studies have 
been conducted in China to date to verify its clinical efficacy. Therefore, 3M plans to conduct 
a study in China aimed at exploring the clinical efficacy of Tegaderm CHG dressings in 
inhibiting bacterial colonization at CVC tips in the current clinical practice and healthcare 
environment in China.   
This trial will follow the applicable principles in the Declaration of Helsinki and the 
Chinese Medical Device GCP Order No.25 (2016).  
2.1 
Description of Study Device 
3M™ Tegaderm™ CHG I.V. Securement Dressing consists of a transparent dressing and 
a gel pad. The gel pad contains 2% (w/w) chlorhexidine gluconate (CHG). CHG is a classical 
germicide with broad-spectrum antibacterial and antifungal activity. The transparent dressing 
acts as a barrier to protect the venipuncture site, effectively blocking external contamination, 
including fluids (waterproof), bacteria, virus and fungi.   
In vitro tests have demonstrated that: The transparent film of Tegaderm CHG dressing can 
block viruses of up to 27nm or larger diameter in intact and unbroken conditions. The barrier 
to viruses is based on the physical properties of the dressing, rather than the auxiliary properties 
of CHG.  
In vitro tests for germicidal time and inhibition zone proved that:  The gel pad in Tegaderm 
CHG dressing is inhibitory to a wide range of gram-positive/negative bacteria and yeasts. 
Tegaderm CHG dressings are transparent for continuous observation of the puncture site and 
are breathable to allow moisture to escape.  
The control product is a CHG-free transparent dressing used to cover and protect the 
catheterization site on the body surface and to secure the device to the skin, without any 
antibacterial ingredients, which is the currently most commonly used transparent dressing in 
DVC care in China.  
3.0 
STUDY DEVICE INFORMATION 
Trial product   
Working principle:  
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.   

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Product model:  1657R, 1658R, 1659R, 1660R 
Size:    1657R, 8.5 cm x 11.5 cm (3-12 in x 4-1/2 in);  
1658R, 10 cm x 12 cm (4 in x 4-3/4 in);  
1659R, 10 cm x 15.5 cm (4 in x 6-1/8 in);  
1660R, 7 cm x 8.5 cm (2 3/4 in. x 3 3/8 in)  
The average CHG content (mg of CHG contained in the gel pad) of a single piece of 
dressing: 45 mg for both 1657R and 1658R; 78 mg for 1659R and 15 mg for 1660R.  
Product usage  
3M™ Tegaderm™ CHG Chlorhexidine Gluconate I.V. Securement Dressings is used to 
cover and protect catheter sites and to secure devices to skin.  
Indications  
The product is suitable for covering and protecting catheterization sites (covering arterial and 
venous catheters, intravascular catheters and percutaneous devices) on the body surface and 
securing the device to healthy skin. This product should not be used on infected wounds or 
unhealthy skins.   
Contraindications   
1. Do not use on patients with known hypersensitivity to chlorhexidine gluconate or alcohol;  
2. Do not use at catheter insertion sites with dermatitis, burns, lesions or tattoos.  
Warning  
1. Use on infants with caution.  
2. For external use only. Do not contact the product with ears, eyes, mouth or mucous 
membranes.  
Precautions   
1. The product shall not be used on broken wounds or unhealthy skin.  
2. The product shall not be re-sterilized by gamma, electron beam or steam.  
3. The skin must be dry and free of soap and hand sanitizer residue to prevent skin irritation 
and ensure good adhesion.  
Possible adverse reactions associated with chlorhexidine gluconate   
1. Occasionally, it can cause contact dermatitis. Highly concentrated solutions are highly 

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irritating to the eyes and conjunctiva.  
2. Rare cases of local irritation and allergic reactions have been reported.  
3. Children who accidentally eat it may develop symptoms of alcohol poisoning (e.g. slurred 
speech, drowsiness, wobbly gait, etc.) and there should be no delay in emergency medical 
treatment.  
Control product  
3MTM TegadermTM Transparent Film Dressing 1626W  
Working principle  
The main purpose is to secure devices to skin.  
Product features   
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.  
Product usage   
The product is used to cover and protect catheter sites on the body surface and to secure devices 
to skin.  
Indications   
It can be used to cover and protect catheter sites and wounds, maintain a moist environment, 
and also be used as a secondary dressing to cover those areas of skin susceptible to damage or 
abrasions or to secure devices.  
Contraindications   
There are no known contraindications.  
Warning:  
1．This product shall not be used as a substitute for sutures and other primary wound closures.  
2．This product shall not be used on infected catheter sites or infected wounds.  
Precautions   
1．Apply dressing until bleeding has stopped.  

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2．The dressing shall not be stretched during application, as tension can cause skin trauma.  
3．The skin must be dry and free of soap and hand sanitizer residue to prevent skin irritation 
and ensure good adhesion.  
4．Dressings shall not be re-sterilized by gamma, electron beam or steam.  
5．Antibacterial ointments containing polyethylene glycol may disrupt the strength of the film.  
6．This dressing may be used on infected areas only under the care of a healthcare professional.  
Table 3.0-1: Device Information  
Name of device  
Model  
3MTM 
TegadermTM 
CHG 
I.V. 
Securement Dressing  
1657R, 1658R, 1659R, 1660R 
3MTM 
TegadermTM 
Transparent 
Dressing  
1626W 
 
3.1 
Device Regulatory Classification 
The test device is imported Class II medical device with the license of GXZJ No.20163642045. 
The control device is imported Class II medical device with the license of GXZJ 
No.20182642129.  Both have been registered in China.  
3.2 
Intended Use of Device 
The subject device 3MTM TegadermTM CHG I.V. Securement Dressing is used to cover and 
protect catheter sites and to secure devices to skin.  
The control product transparent dressing is used to cover and protect catheter site on the body 
surface and secure devices to skin.  
Both products are used in accordance with the hospital's catheterization standard and catheter 
line maintenance procedure.  
 

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3.3 
Risks and Benefits of the Device(s) Used in this Study 
3.3.1 
Risks of the Device 
Dressings are considered to be low-risk medical devices and are commonly used in 
health care and at home with few problems reported. Potential risks to subjects 
include possible localized skin irritation: such as itching, erythema and rash, some 
minor pain and erythema during removal, contact dermatitis and systemic allergic 
reactions, and skin stripping without any long-term effect. If the investigator 
discovers any erythema symptom equal to or greater than Grade 3 (0-4 scale; see 
Appendix B for grading details), or if any allergic reaction occurs, its use shall be 
discontinued for that subject. 
3.3.2 
Anticipated Adverse Device Effects 
Skin and subcutaneous tissue reactions/allergies:  
1. Dryness/damage  
2. Rash, irritation, blisters  
3. Pruritus/itching  
4. Excoriation/skin ulceration  
5. Skin peeling  
6. Skin scarring in the case of significant skin irritation  
7. Skin maceration  
8. Hyperpigmentation/hypopigmentation in and/or around the area of dressing 
application  
9. Erythema/redness, edema, inflammation or swelling in and/or around the 
area of dressing application  
Mild discomfort:  
1. Sweating due to the use of dressings  
2. Abnormal sensations (numbness, tingling, prickle, formication)  
 

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Possible adverse reactions associated with chlorhexidine gluconate   
1. Occasionally, it can cause contact dermatitis. Highly concentrated solutions 
are highly irritating to the eyes and conjunctiva.  
2. Rare cases of local irritation and allergic reactions have been reported.  
3. Children who accidentally eat it may develop symptoms of alcohol 
poisoning (e.g. slurred speech, drowsiness, wobbly gait, etc.) and there 
should be no delay in emergency medical treatment.  
 
Others:  
1. Local infection  
2. Limited mobility/movement  
3. Poor securement causing catheter to partially slip out  
4. Systemic reactions (caused by allergic reactions to the dressing) 
3.3.3 
Residual Risks 
Residual Risks of using tape over a long period or with multiple applications, 
subjects may develop sensitivity to the adhesives used in these products. 
Hypo/hyper pigmentation, etc. 
3.3.4 
Risk of Interactions with Concomitant Medical Treatments 
There is minimal risk of interactions with any medical treatments the study 
subjects would receive as part of standard medical treatment. 
3.3.5 
Mitigation of Risk 
Risk related to the device may be mitigated or controlled through appropriate 
selection of study subjects for inclusion into this study, adherence to this Clinical 
Investigation Plan, and reporting of Adverse Events, Device Deficiencies and 
deviations to the Sponsor. If the subject experiences any discomfort, the 

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investigators could discontinue the clinical trial and conduct appropriate treatment 
and care based on clinical judgment. 
3.3.6 
Benefits of the Device 
There is no guarantee of benefits. However, several overseas studies support the 
clinical efficacy of Tegaderm CHG dressings in reducing bacterial colonization on 
skin and catheters.  
3.3.7 
Risk to Benefit Rationale 
Based on the risks and benefits listed above, and according to this clinical study 
protocol, the subjects will not face a greater risk of harm than those who do not 
participate in this study because the control product is what is used in the treatment 
that subjects would receive if they did not participate in this study. And both the 
test product and the control product are commonly used in hospitals. 
4.0 
DESIGN OF CLINICAL INVESTIGATION 
4.1 
Design 
This clinical trial is designed as a prospective, randomized, open-label, parallel-
group controlled trial.  
4.1.1 
Scientific Rationale for Design 
The control device has been commonly used for DVC securement in clinical 
institutions in China and is a routine product used in clinical trial centers.  
This is an open-label trial, and because there are visible differences in the outer 
packaging and appearance of the devices used in two groups, it would be 
impossible to blind either the investigators or the subjects. 
4.1.2 
Minimization of Bias 
The following measures have been taken to minimize or avoid bias in this study: 

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 Randomization: The random assignment gives each subject an equal 
chance of being assigned to either the test or control group without being 
influenced by the subjective intention of the investigator and/or the subject, 
allowing for a balanced distribution of multiple influence factors and 
avoiding selection bias or information bias as much as possible. This trial 
will use a random assignment approach to reduce bias due to sampling 
difference. After investigators confirm and verify the inclusion and 
exclusion criteria, eligible subjects will be randomly assigned to either the 
test group or the control group to receive treatment. The random number 
table is generated by a biostatistician using a program before the first 
enrollment. 
 Parallel-group control: A parallel-group controlled approach is used in the 
trial design. Treatment of both test and control groups will be conducted 
concurrently so that factors that may affect the validity assessment are 
evenly distributed between the two groups. 
5.0 
OBJECTIVES OF THE CLINICAL INVESTIGATION PLAN 
5.1 
Primary Objective(s) 
The primary objective of this study is compare the difference in the bacterial colonization rate 
at the CVC tip and the catheterization site on the skin after removal (number of culture-
positive cases/total catheters × 100%) between the test and control groups.  
5.2 
Secondary Objective(s) 
The secondary objective of this study is to compare the differences in the following indicators 
between the test and control groups:  
 
Number of positive cases per 1,000 catheter-days of bacterial colonization at CVC tips  
 
Bacterial colonization rate at the tip of other types of (percutaneous) deep vein catheters 
and the catheterization site (number of culture positive cases/total catheters x 100% and 
number of positive cases per 1,000 catheter-days), including hemodialysis, PICCO, float 
catheters, etc.  

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 
Incidence rate of Central Line Associated Bloodstream Infections (CLABSI) or Catheter 
Related Blood Stream Infections (CRBSI)  
 
Type of pathogenic microorganism (G+/G-/fungal or specific species, drug-resistant 
bacteria, etc.) and percentage of positivity  
 
Securement performance of the dressing: Frequency of dressing changes associated with 
wear time and lift or drop-off 
 
Effects on the skin of the covered area, e.g. local infection, local skin irritation.  
5.3 
Endpoint(s) 
5.3.1 
Primary Endpoint(s) 
The bacterial colonization rate at the CVC tip and the catheterization site on the 
skin after removal (number of culture-positive cases/total catheters × 100%) 
The primary endpoint is the removal of the CVC from the patient with deep vein 
catheterization to perform catheter-tip culture and sampling and culture of bacteria 
from the skin around the insertion site. 
5.3.2 
Secondary Endpoint(s) 
Removal of other types of DVCs, such as hemodialysis and PICCO to perform 
catheter-tip culture and sampling and culture of bacteria from skin around the 
insertion site;  
Occurrence of suspected CLABSI/CRBSI, performing catheter-tip culture and 
blood bacterial culture;  
Dressing securement performance, such as lift or drop-off;  
Safety indicators, mainly referring to the effect of the dressing on the state of the 
skin. 

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6.0 
POPULATION AND DURATION 
The study will include 440 study subjects. The study will be conducted simultaneously in two 
ICU wards of Shanghai Ruijin Hospital.  
The overall study is expected to last a total of 15 months. Depending on the subject's disease 
condition and treatment schedule, each subject's treatment duration with the same deep vein 
catheter is essentially no more than 2 weeks, so their participation in the study will last for 
approximately 3-14 days.  
7.0 
ENROLLMENT CRITERIA 
Subjects enrolled in this clinical study must meet all the inclusion criteria and none of the 
exclusion criteria, as listed in the sections below. 
7.1 
Inclusion Criteria 
Subjects may be included that meet the following criteria: 
Table 7.1-1: Inclusion Criteria 
Number
Inclusion Criteria 
IC - 1 
The subject is 18 years old or older at the time of providing consent. 
IC - 2 
The subject will be available to attend all visits required in the trial and have an 
expected length of stay in the ICU no less than 3 days. 
IC - 3 
The subject or his/her legally authorized representative is competent to sign the 
informed consent form 
IC - 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 
IC - 5 
The patient's catheter insertion site is free of deformities, phlebitis, infiltrations, 
dermatitis, eczema, rashes, breaks, burns, tattoos, or other skin conditions that 
could affect the integrity of the skin at the insertion site 
IC - 6 
The patient will comply with the DVC treatment process and the nursing 
process prescribed in this protocol 
 

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7.2 
Exclusion Criteria 
Subjects must be excluded from participating in this study if they meet any of the following 
criteria: 
Table 7.2-1: Exclusion Criteria 
Number
Exclusion Criteria 
EC - 1
The subject is unwilling/unable to attend the study visits. (Different from IC) 
EC - 2 
There is sunburn, skin infections or scars, moles or other blemishes on the 
subject's catheter site that would affect the scoring or measurement of the test 
site  
EC - 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
EC - 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 
EC - 5 
The patient is being or has been subjected to other antibiotic, catheter or skin-
related clinical trials 
EC - 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 
EC - 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
EC - 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  
EC - 9
Women who are pregnant or breastfeeding 
EC - 10 
Other patients deemed unsuitable for this trial by the investigator's judgment 
8.0 
INFORMED CONSENT PROCESS 
Informed Consent must be obtained for all subjects prior to any study activities being 
performed or data being collected.  The Investigator or designee will review all relevant 
aspects of the study with the potential study subject that are relevant to the subject’s decision 
to participate throughout the study.  The Investigator or designee will provide ample time for 

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the subject to read and understand the IRB/EC approved Informed Consent Form and to 
consider participation in the study.   
The study subject or legal authorized representative must sign and date the Informed Consent 
Form.  The Investigator or designee must sign and date the Informed Consent Form.  The 
Informed Consent Process must be documented by the Investigator or designee.   
The Informed Consent Process includes documentation of the discussion regarding study 
procedures, subject concerns, that the subject was provided ample time to consider 
participation, and that all questions were answered prior to participation in any research 
activity. 
The Investigator or designee must file the original Informed Consent Form and provide the 
subject with a copy of the signed and dated Informed Consent and any other written 
documentation per local IRB/EC requirements. 
In order to minimize pressure and undue influence on vulnerable subjects, the Investigator or 
designee who is obtaining Informed Consent should ensure appropriate communication 
techniques, such as visual aids and avoidance of jargon, in order to ensure minimal pressure 
and undue influence is avoided. 
9.0 
POINT OF ENROLLMENT AND EXIT 
9.1 
Point of Enrollment 
Following recruitment and eligibility screening, a subject will sign the informed consent form.  
A subject is considered enrolled in this study at time the Informed Consent process has been 
completed.   
Eligible and consented subjects will be assigned a unique subject identification number, 
which will not contain information that could identify the subject. 

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9.2 
Point of Exit 
Study subjects may exit the study for a variety of reasons. The Investigator shall record the 
reason for withdrawal and discontinuation of the study in the applicable Case Report Form.  
These reasons include, but are not limited to: 
 Study completion (all study related visit(s) are completed) 
 Withdrawal by the Subject 
 Withdrawal by Investigator 
 Lost to follow-up 
 Death 
 Study Termination 
If a subject withdraws or discontinues participation before study completion, the subject will 
not be accounted into the per protocol set (PPS) analysis until the required enrollment is reached 
but will be accounted into the safety set analysis.  
Data collected until the last known contact of study subject may be used in the analysis of 
study data. Because the subjects in this study are all ICU patients, patients will be considered 
lost to follow-up if they are transferred out of the ICU or discharged without removal of the 
CVC. If the study subject withdraws from the study for any reason and there is an ongoing 
safety event, additional safety event information may need to be collected by the Investigator 
and shared with Sponsor.  
10.0 
PROCEDURES 
The following sections describe the study procedures and data which will be collected at each 
procedure for the duration of the study.  The data listed below, and any relevant safety data 
will be collected during this study. 
10.1 
Procedure Diagram 
 
 
Signing of informed consent form, enrollment of subjects based on inclusion and 
exclusion criteria, etc.  

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First visit   
(Day 0)  
 
 
 
Dressing  
change visits  
(Several times,  
Day 3-14)  
 
 
 
 
 
 
End of visit  
 
 
 
Random assignment  
Control 
Group 
Test  
Group  
Baseline survey (demographic data, vital signs, past medical history, blood work, etc.)  
Documentation of deep vein catheterization and assessment of surrounding skins  
Initial study intervention (dressing application or change)  
Documentation of relevant concomitant medication  
Subject product evaluation  
Repeated study intervention (dressing change)  
 Skin assessment around the catheter site  
Documentation of relevant concomitant medication  
Recording safety indicators  
Endpoint Assessment  
Catheter-tip bacterial culture  
Skin bacterial culture  
Blood bacteriological culture (if 
necessary)  
Other endpoint assessments  
Recording safety indicators  

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10.2 
Visits 
After Informed Consent has been obtained, the following study procedures will be performed.  
All applicable data are to be recorded in the applicable Case Report Form (CRF). 
10.2.1 
Randomization 
Subjects will be randomly assigned to either the test or control group using an online 
randomization service by a 1:1 assignment ratio.  
10.2.2 
Visit 1/Enrollment Visit/Baseline Visit (Study Day 0) 
The following procedures will be completed at Visit 1:   
1. Confirmation of subjects' eligibility and assessment of inclusion/exclusion 
criteria;   
2. Randomization of patients who met the inclusion criteria;  
3. Assessment of the skin condition around the catheter site.  
4. Performing immediate dressing changes at all DVC insertion sites based on 
subjects' conditions at enrollment, using either the subject device 3MTM 
TegadermTM CHG I.V. Securement Dressing or the 3MTM TegadermTM 
Transparent Film Dressing as per randomization results, and following 
routine departmental nursing procedures;  
The following data will be collected at the first visit:  
1. Demographic information (height, weight, gender, age at consent);  
2. Past medical history and allergic history, collected according to HIS records: 
Collection of medical and allergic history within the last 3 months related to 
the inclusion/exclusion criteria, including but not limited to diabetes, 
immune-related diseases, skin conditions, etc.;  
3. Vital signs: Pulse, blood pressure, respiratory rate, body temperature;  
4. Relevant laboratory tests, including blood routine examination: Red blood 
cell (RBC) count, white blood cell (WBC) count, neutrophil ratio, 
hemoglobin, platelets, C-reactive protein, etc.;  

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5. DVC type, site of insertion, duration, documentation of any post-puncture 
exudation, application of any other products such as gauze, hemostatic pads, 
etc.;  
6. Documentation of skin conditions around the catheter site, scoring with 
reference to the standards for evaluating local skin irritation as listed in the 
appendix;  
7. Medication use in relation to the trial, including mainly fat emulsions, 
heparin, blood transfusions and antimicrobial drugs;  
8. Adverse events, device defects, complaints.  
10.2.3 
Follow-up visits (number of visits to be marked if there are multiple visits 
during each dressing change) 
Since the expected use duration of the test/control product is a maximum of 7 
days, there will be at least one visit on the seventh day into the trial (if 
catheterization duration is longer than 7 days), and more visits could be taken on a 
case-by-case basis. The following procedures will be completed at Follow-up 
visits:   
1. Performing dressing changes in accordance with routine departmental 
nursing procedures;  
2. Assessment of skin conditions around the catheter site, with reference to the 
standards for evaluating local skin irritation as listed in the appendix;  
The following data will be collected during the follow-up visit: 
1. Date and time of dressing change, site of dressing change, reason for 
dressing change. Scoring and assessment of edge curling in the case of 
dressing changes due to severely edge curling in the previous use;  
2. Documentation of skin conditions around the catheter site, including 
erythema, edema, rash, etc., and scoring with reference to the standards for 
evaluating local skin irritation as listed in the appendix.  
3. Any changes in medication use relevant to the trial, including mainly fat 
emulsions, heparin, blood transfusions and antimicrobial drugs;  
4. Adverse events, device defects, complaints. 

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10.2.4 
End-of-treatment Visit 
Visit following the completion of dressing securement at the insertion site after 
removal of DVC. A patient who has multiple catheters withdrawn during the trial 
should be documented sequentially, but the trial is not to be considered complete 
at least until the CVC is removed. If replacement of the same type of DVC is 
performed, only the first removal is recorded and the subsequent replacement is 
not included in the test or observation. 
The following procedures will be completed during the end-of-treatment visit:   
1. Assessment of dressing securement performance;  
2. Assessment of skin conditions around the catheter site, with reference to the 
standards for evaluating local skin irritation as listed in the appendix;  
3. Photographic documentation of any anomalies;  
4. Following departmental routine practice, the tip is cut with sterile scissors 
after removal, while skin sampling around the insertion site is performed. 
The samples taken are, under aseptic conditions, sent for pathogenic bacteria 
testing and species analysis.  
5. In case of suspected CLABSI/CRBSI occurrence, sampling and quantitative 
culture for both catheter and peripheral blood will be performed 
simultaneously, as well as analysis of pathogenic bacteria species, according 
to diagnostic evaluation criteria. 
The following data will be collected during the end-of-treatment visit:   
1. Vital signs: Pulse, blood pressure, respiratory rate, body temperature;  
2. Relevant laboratory tests, including blood routine examination: Red blood 
cell (RBC) count, white blood cell (WBC) count, neutrophil ratio, 
hemoglobin, platelets, C-reactive protein, etc.;  
3. Documentation of dressing securement performance;  
4. Documentation of skin conditions around the catheter site, including 
erythema, edema, rash, etc., and scoring with reference to the standards for 
evaluating local skin irritation as listed in the appendix.  

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5. Total duration of DVC placement and duration of application of the 
test/control dressing;  
6. Catheter-tip culture and classification of colonies;  
7. Culture and classification of colonies from the skin samples around the 
insertion site;  
8. Any changes in medication use relevant to the trial, including mainly fat 
emulsions, heparin, blood transfusions and antimicrobial drugs;  
9. Confirmation of CLABSI/CRBSI  diagnosis;  
10. Adverse events, device defects, complaints.  
Any Adverse Events, which are not safety related, and which are ongoing at 
the end of the study, should be marked as ‘persistent’ per study-specific CRF. 
10.3 
Schedule of Events 
A schedule of events is in the table below: 
Table 10.3-1: Schedule 
Process  
Screening and 
enrollment  
Day 0 
Dressing 
change visits  
End-of-
treatment visit1  
Withdrawal or 
discontinuance of 
visits2  
Informed consent collection 
X 
 
 
Assessment of 
inclusion/exclusion criteria  
X 
 
 
 
Randomization 
X 
 
 
Demographic data a 
X 
 
 
Previous medical history  
X 
 
 
Vital signs b  
X 
 
X 
X
Routine blood examination 
c 
X 
 
X 
X 
Record of deep vein 
catheterization 
X 
 
X 
X 
Skin assessment around the 
catheter site  
X 
X 
X 
X 
Dressing application or 
change (multiple times)  
X 
X 
 
 
Documentation of relevant 
concomitant medication 
X 
X 
X 
X 
Evaluation of subject 
product (dressing edge 
curling, etc.)  
 
X 
X 
X 

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Total duration of 
catheterization   
 
 
X 
 
Total duration of 
test/control dressing use  
 
 
X 
 
Catheter-tip bacterial 
culture  
 
 
X 
 
Bacterial culture from skin 
samples around the 
insertion site  
 
 
X 
 
Blood bacteriological 
culture  
 
 
X 
 
AE/SAE 
X 
X
X 
X
Device defects  
X 
X
X 
X
 
Note:  
a： Date of birth, gender, ethnicity, height, weight, etc.;  
b： Pulse, blood pressure, respiration, temperature;  
c： Red blood cell (RBC) count, white blood cell (WBC) count, neutrophil ratio, hemoglobin, 
platelets, C-reactive protein, etc.;  
1: There may be multiple visits documented when multiple deep vein catheters are removed in 
succession;  
2. For subjects withdrawing from or discontinuing the trial.  
11.0 
SAFETY AND EVENT REPORTING 
Subject safety and event reporting are important in this study.  Investigators are responsible 
for ensuring that all safety events are recorded in the subject record(s). Events defined in 
Section 11.3 will be reported to the Sponsor, as applicable, per the timelines in Section 11.4. 
11.1 
Safety Oversight – Sponsor 
Safety oversight will be under the direction of the Medical Director(s) of 3M, which is 
composed of individuals with the appropriate expertise.  The Medical Director(s) routinely 
review and assess the safety data of the study. 

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11.2 
Safety Recording and Reporting Requirements – Investigator 
It is the responsibility of each participating Investigator to ensure all safety events are 
recorded in the subject’s record.  The Investigator is responsible for reporting to the Sponsor 
safety events as defined in Section 11.44. 
11.3 
Safety and Event Reporting Definitions 
This study utilizes the following definitions, as listed in the table below. 
Table 11.3-1: Definitions 
Term 
Definition 
Adverse Event 
(AE) 
Any untoward medical occurrence, unintended disease or injury, or 
untoward clinical signs (including abnormal laboratory findings) in 
subjects, users or other persons, whether or not related to the 
investigational medical device.
Adverse Device 
Effect (ADE)  
An adverse event related to the use of an investigational medical 
device. This includes any adverse events resulting from insufficient or 
inadequate instructions for use, deployment, implantation, installation, 
or operation, or any malfunction of the investigational medical device. 
This includes any event that is a result of a user error or intentional 
misuse of the investigational device.  
Serious Adverse 
Event (SAE) 
Any adverse event that: 
• Led to death 
• Led to serious deterioration in the health of the subject, that either 
resulted in 
o a life-threatening illness or injury 
o a permanent impairment of a body structure or a body function 
o in-patient or prolonged hospitalization,  
o • medical or surgical intervention to prevent life-threatening 
illness or injury or permanent impairment to a body structure or 
a body function 
• Led to fetal distress, fetal death or a congenital anomaly or birth 
defect  
 
NOTE: Planned hospitalization for a pre-existing condition, or a 
procedure required by the Clinical Investigation Plan without serious 
deterioration in health, is not considered a SAE

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Term 
Definition 
Serious Adverse 
Device Effect 
(SADE) 
An adverse device effect that has resulted in any of the consequences 
characteristic of a serious adverse event 
Unanticipated 
Serious Adverse 
Device Effect 
(USADE)  
A serious adverse device effect, which by its nature, incidence, 
severity, or outcome has not been identified in the current version of 
the risk analysis report 
Device Deficiency 
(DD)  
An inadequacy of a medical device with respect to its identity, 
quality, durability, reliability, safety, or performance, such as 
malfunctions, use errors, and inadequate labelling
Complaint  
Any written, electronic, or oral communication that alleges 
deficiencies related to the identity, quality, durability, reliability, 
safety, effectiveness, or performance of a device after it is released 
for distribution
 
11.3.1 
Severity Ratings 
The table below defines the severity ratings for events.  The Investigator shall 
ensure rating of reportable events on the applicable Case Report Form. 
Table 11.3.1-1: Severity Ratings Definitions 
Term  
Definition 
Mild 
An event that is easily tolerated by the subject, causing minimal 
discomfort and not interfering with everyday activities
Moderate 
An event that is sufficiently discomforting to interfere with normal 
everyday activities
Severe
An event that prevents normal everyday activities
 
11.3.2 
Relatedness 
The table below defines the relatedness definitions for events.  The Investigator 
shall ensure rating of reportable events on the applicable Case Report Form. 

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Table 11.3.2-1: Relatedness Definitions 
Term  
Definition 
Not Related 
Relationship to the device or procedure can be excluded
Possible 
Relationship with the use of the study device is weak but cannot be 
ruled out completely.
Causal 
The event is associated with the study device or with the procedures 
beyond a reasonable doubt when: 
- 
The event is a known side effect of the device 
- 
The event has a temporal relationship with the study 
device/application procedures 
- 
The event involves a body/site or organ that 
o The device or procedures are applied to; 
o The device or procedures have an effect on 
- 
The event follows a known response pattern to the device
 
11.4 
Safety and Event Sponsor Reporting Requirements 
This study requires that the following events be reported to the Sponsor, in addition, to 
completing Case Report Form: 
 Reportable Adverse Device Effects, as described in Section 3.3.2 
 Any Adverse Events deemed by the Investigator to be related to participation in 
the study and considered to be due to the study intervention or comparator product. 
 All Unanticipated Adverse Device Effects 
 All Serious Adverse Events, Serious Adverse Device Effects, Unanticipated 
Serious Adverse Device Effects 
 Device Deficiencies  
Devices meeting the performance expectations but not exceeding performance 
expectations will NOT be captured as device deficiencies.  
 Any Complaint related to any 3M commercially available product used in the 
study.   
The Investigator shall report information relating to the event, and include dates of the event, 
severity rating, treatment, seriousness and relationship to the investigational device. 

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Any Adverse Events, which are not safety related, which are ongoing at the end of the study 
should be marked as “persistent’ per study specific CRF.  Any Events which related to safety 
OR are persistent and deemed related to the study device, may be followed for an additional 
30 calendar days.  Events reported by subjects after the last study visit may be reported to the 
Sponsor up to 30 calendar days from the date of the last visit.  
11.4.1 
Reporting Timelines 
The table below indicates the reporting timelines for events to the Sponsor.  The Investigator 
shall report to local IRB/EC and local regulatory authorities, per local requirements.  
Reporting to Sponsor begins when study staff are aware of the event.  For any event listed in 
the table below, study Sponsor may request additional information from the Investigator, 
including but not limited to, medical records, laboratory testing, radiological results, etc. 
regarding the event. 
Table 11.4-1: Safety Reporting Timelines  
Type of event 
Report to Sponsor 
Method 
Adverse Events (AE) 
deemed by the Investigator 
to be related to participation 
in the study and considered 
to be due to the study 
intervention or comparator 
product.
Per protocol visits/ Per 
month 
Complete CRF 
Unanticipated Adverse 
Device Effect (UADE) 
Per protocol visits/ Per 
month
Complete CRF 
Serious Adverse Event 
(SAE)/Serious Adverse 
Device Effect (SADE)
Within 24 hours of study 
staff becoming aware of 
event
Initial: Phone/Email to 
Sponsor 
Followed by: Complete CRF
Unanticipated Serious 
Adverse Device Effect 
(USADE)
Within 24 hours of study 
staff becoming aware of 
event
Initial: Phone/Email to 
Sponsor 
Followed by: Complete CRF
Device Deficiency (DD) 
Within 3 business days of 
becoming aware of event
Complete CRF 

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Type of event 
Report to Sponsor 
Method 
Product Complaints on 3M 
Marketed Product
Within 3 business days of 
becoming aware of event
Complete CRF 
 
12.0 
DEVIATIONS 
A deviation is a departure from the Clinical Investigation Plan that will likely affect the 
safety, rights or welfare of subjects, the scope of the investigation or the scientific quality of 
the study.  A deviation report form shall be completed per event per individual subject.  
Deviations are documented on a deviation report form or appropriate Case Report Form 
(CRF).  The Investigator is responsible for reporting deviations to the reviewing IRB/EC, per 
local requirements. 
12.1 
Deviation Reporting Timelines 
Table 12.1-1: Deviation Reporting Timelines 
Type of Deviation 
Report to Sponsor 
Method 
Subject safety, rights or welfare; OR 
Data integrity; OR 
Compromise the statistical analysis of 
the study; OR 
Lack of Informed Consent; OR 
Inclusion/Exclusion 
Within 24 hours of 
study staff becoming 
aware of event 
Initial: Phone/Email to 
Sponsor 
Complete CRF 
All other protocol deviations 
Per protocol visits 
Complete CRF 
 
13.0 
PREMATURE STUDY TERMINATION 
Both the Sponsor and the Principal Investigator (PI) reserve the right to terminate the clinical 
investigation at any time. Should this be necessary, the procedures will be arranged on an 
individual basis after review and consultation by both parties. In terminating the clinical 

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investigation, the 3M study team and the Principal Investigator will assure that adequate 
consideration is given to the protection of the subject’s interests. 
This study may be temporarily suspended or prematurely terminated if there is sufficient 
reasonable cause.  Written notification, documenting the reason for study suspension or 
termination, will be provided by the suspending or terminating party to study participants, 
participating Investigators, IRB/EC’s and regulatory authorities.  If the study is prematurely 
terminated or suspended, the Principal Investigator (PI) will promptly inform study 
participants, the IRB/EC’s, and Sponsor and will provide the reason(s) for the termination or 
suspension.  Study participants will be contacted, as applicable, and be informed of changes to 
study visit schedule. 
Circumstances that may warrant termination or suspension include, but are not limited to: 
 Determination of unexpected, significant, or unacceptable risk to participants 
 Demonstration of efficacy that would warrant stopping    
 Insufficient compliance to Clinical Investigation Plan requirements 
 Data that are not sufficiently complete and/or evaluable 
 Determination that the primary endpoint has been met 
 Determination of futility 
Suspended studies may resume once concerns about safety, Clinical Investigation Plan 
compliance, and data quality are addressed, and satisfy the Sponsor, IRB/EC and regulatory 
authorities. 
14.0 
MONITORING 
Study monitoring is conducted to ensure that the rights, safety and well-being of study 
participants are protected, that the reported study data are accurate, complete, and verifiable, 
and that the conduct of the study is in compliance with the currently approved Clinical 
Investigation Plan (CIP), with GCP, and with applicable regulatory requirement(s).   

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3M or its designee, as Sponsor of this clinical investigation, is responsible for ensuring the 
proper conduct of the clinical investigation with regard to CIP adherence and validity of the 
data recorded on the CRFs. 3M, has therefore assigned study monitor(s) to this clinical 
investigation. The progress of the clinical investigation will be monitored by: 
 Periodic and/or remote review 
 Telephone communications  
 Review of CRFs and source documents (e.g. subject records) 
The study monitor(s), other authorized representatives of the Sponsor, representatives of the 
IRB/EC, or regulatory authorities may inspect all documents and records required to be 
maintained by the Investigator, including but not limited to, subject records (office, clinic, or 
hospital) for the participants in this study. The clinical study site will permit access to such 
records.  The Investigator will give 3M study monitor(s) direct access to source documents 
that support data on the CRFs.   This includes any electronic records. 
Investigator non-compliance of required study responsibilities will require Sponsor sanctions 
to alleviate the non-compliance. Including corrective and preventative actions up to and 
including disqualification. 
Details of clinical site monitoring are documented in a Monitoring Plan (MP). The MP 
describes in detail who will conduct the monitoring, at what frequency monitoring will be 
done, at what level of detail monitoring will be performed, and the distribution of monitoring 
reports. 
Independent audits may be conducted by GCP ClinPlus Co., Ltd, CHINA to ensure 
monitoring practices are performed consistently across all participating sites and that monitors 
are following the MP. 

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15.0 
ROLE OF SPONSOR REPRESENTATIVE 
In addition to study monitoring, the Sponsor, or their representatives may conduct the 
following tasks during this study: 
 Audits of the Investigator 
 Provision of technical support/product specific training for the study device 
16.0 
DEVICE ACCOUNTABILITY 
The device(s) under investigation will not be distributed to the investigational site until all 
agreements between the site and 3M are finalized and IRB/EC approval has been obtained. 
3M requires that Investigators maintain device accountability and security of the devices at all 
times. The Investigator or designee will:  
 Maintain and account for devices at the Investigator site 
 Keep devices in a secure storage area, accessible only to authorized individuals. 
 Dispense devices only to subjects properly enrolled in and eligible for the study. 
 Return all unused investigational materials to the Sponsor at the end of the study or 
dispose of as agreed upon. 
16.1 
Device Labeling 
Devices utilized in this study will be labelled according to applicable regulations.  A sample 
label will be retained in the Investigator Site File. 
16.2 
Additional Study-Specific Equipment/Device(s) 
Additional study-specific equipment/devices used in this study shall be maintained, calibrated 
(if applicable) and ensured to be functioning correctly during the study, in accordance with 
this study Clinical Investigation Plan or applicable site policy and regulatory requirements.  
The Sponsor should be notified of any anticipated or known issues with the device 
functionality that may impact the study conduct or outcome. 

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17.0 
CONFIDENTIALITY 
Participant confidentiality and privacy is strictly held in trust by the participating 
Investigators, their staff, and the Sponsor(s) and their authorized representatives. This 
confidentiality is extended to cover testing of biological samples and genetic tests in addition 
to the clinical information relating to participants. Therefore, the Clinical Investigation Plan, 
documentation, data, and all other information generated will be held in strict confidence. No 
information concerning the study, or the data will be released to any unauthorized third party 
without prior written approval of the Sponsor. All research activities will be conducted in as 
private a setting as possible. 
Study data, which is for purposes of statistical analysis and scientific reporting, will be 
transmitted to and stored at 3M or approved supplier. This will not include the participant’s 
contact or identifying information. Rather, individual participants and their research data will 
be identified by a unique study identification number. The electronic data capture system used 
by clinical sites and by 3M research staff will be secured and password protected. At the end 
of the study, all study databases will be de-identified and archived at 3M or approved 
supplier.  
17.1 
Future Use of Stored Collected Specimens 
With the participant’s approval and as approved by the local IRB/EC, de-identified biological 
samples will be stored at 3M with the same goal as the sharing of data with the 3M 
researchers.   
During the conduct of the study, an individual participant can choose to withdraw consent to 
have biological specimens stored for future research. However, withdrawal of consent with 
regard to biosample storage may not be possible after the study is completed. 

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18.0 
DATA HANDLING AND RECORD KEEPING 
Data collected for this study will be analyzed and stored at 3M or an approved supplier for use 
by researchers including those outside of the study. Permission to transmit, store and use data 
outside of the study will be included in the informed consent. 
18.1 
Data Collection and Management Responsibilities 
Data collection is the responsibility of the clinical study staff at the site under the supervision 
of the site Investigator. The Investigator is responsible for ensuring the accuracy, 
completeness, legibility, and timeliness of the data reported. 
All source documents should be completed in a neat, legible, permanent and un-editable 
manner to ensure accurate interpretation of data.  Data recorded in the electronic case report 
form (eCRF) derived from source documents must be consistent with the data recorded on the 
source documents.  
Data (including adverse events (AEs), concomitant medications, and expected adverse event 
data) will be entered into a 21 CFR Part 11-compliant data capture system provided by 3M. 
The data system includes password protection and internal quality checks, such as automatic 
range checks, to identify data that appear inconsistent, incomplete, or inaccurate. 
18.2 
Study Records Retention 
The study participant’s information will be securely stored at each clinical site for internal use 
during the study. At the end of the study, all records will continue to be kept in a secure 
location for as long a period as dictated by the reviewing IRB/EC, Institutional policies, 
regulatory authorities or Sponsor requirements. 
No records will be destroyed without the written consent of the Sponsor. It is the 
responsibility of the Sponsor to inform the Investigator when these documents no longer need 
to be retained. 

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18.3 
Sponsor Oversight 
Routine review of submitted study information by the Sponsor will be conducted to ensure 
Clinical Investigation Plan compliance.  Items reviewed include but are not limited to: 
adverse events, deviations, number of withdrawn/terminated subjects; which all may impact 
the completion of the study.  Appropriate measures may be taken to ensure Investigator 
compliance with the Clinical Investigation Plan. 
19.0 
STATISTICAL CONSIDERATIONS 
This is a prospective, randomized, open-label, parallel-group controlled, single-center study 
designed to explore whether the subject product effectively reduces bacterial colonization in 
comparison with the control product. Subjects will be divided into two groups based on the 
random number table.  
For continuous data, descriptive statistics will include the number of subjects, mean, standard 
deviation, median, minimum and maximum values. For categorical data, descriptive 
summaries will be made by frequency and percentage. Unless otherwise specified, a two-
sided test will be used for all statistical tests, and a p-value of less than 0.05 will be 
considered statistically significant for the difference being tested. 
19.1 
Statistical Hypotheses 
19.2 
Sample Size Determination 
This study will use a positive two-sided Z test for continuity calibration and use the O'Brien-
Fleming expenditure function to determine the test boundary.  Assuming a baseline value of 
18.7% for CVC tips colonization rate in the control group (this figure is reported by a domestic 
epidemiological survey) and a reduction rate of 50.0%, each group should contain at least 220 
patients with CVC to reach 80% likelihood at 5% significance level. A total of 440 valid cases 
are required in both groups combined. An interim analysis is scheduled for this study and will 
be conducted after completion of follow-up visits of 220 subjects to correct for the pre-defined 
sample size.  

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19.3 
Population for Analyses 
Full analysis set (FAS): The set of subjects determined according to the principle of Intention 
to Treat (ITT) refers to the data set composed by all subjects who are involved in the trial 
randomly and have used the trial product. The missing data were carried forward using the 
strategy of WCCF (Worst Case Care Forward) in case the primary efficacy endpoints of the 
patients were not observed. FAS is the primary analytical data set for evaluating validity.  
Per protocol set (PPS): PPS is a subset of the FAS and includes subjects randomly assigned 
to treatment with a test or control device who have not experienced significant protocol 
deviations. The PPS is the secondary analytical data set for evaluating validity.  
Safety analysis set (SS): This includes all subjects who have been formally enrolled and 
completed catheterization and dressing securement with the catheter in place for more than 24 
hours. This data set is used to evaluate the safety of this trial.  
19.4 
Statistical Analyses 
For patient baseline characteristics and demographic data, quantitative data will be analyzed 
based on t-test or rank sum test, and qualitative information will be analyzed based on Chi-
square test or Fisher's exact test. CVC tip bacterial colonization rates, PICCO/hemodialysis 
catheter bacterial colonization rates, catheter-related bloodstream infection rates, and microbial 
species analysis will be analyzed by chi-square test or Fisher's exact test. Other results collected 
in this study, such as wearing duration, frequency of replacement, skin condition, and number 
of deaths, will be analyzed using t-tests or rank sum tests accordingly. The O'Brien-Fleming 
expenditure function will be used twice in succession to determine the test boundaries.   
In addition, descriptive summaries of effectiveness and safety evaluation indicators will be 
presented for the entire trial and for subjects in each group. For continuous data, the data will 
be summarized by number of subjects, mean, standard deviation (SD), median, minimum and 
maximum values. For categorical data, they will be summarized by frequency and 
corresponding percentage.  

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19.5 
Planned Interim Analyses and Criteria for Clinical Investigation 
Interim analysis will be conducted at enrollment to 220 subjects, and the total CVC tip 
colonization rate obtained from the interim analysis will be used to recalculate and evaluate the 
sample size.  
19.6 
Procedures for Missing, Unused or Spurious Data 
Data for the validity evaluation indicator and safety evaluation indicator will not be 
interpolated. The interpolation of incomplete data will be further described in SAP.  
Unused or erroneous data in the database will be identified and processed during the data 
management process.  
19.7 
Procedures for Reporting Deviations from Statistical Plan 
If the method of analysis in this protocol changes before the data is locked, it will be 
documented in SAP. If there are changes to the analyses in the final SAP after data locking, 
they should be documented in the Statistical Analysis Report (SAR) and the Clinical Study 
Report (CSR).  
19.8 
Validation Plan 
Independent validation of statistical plans and outputs will not be performed, and standard 
validation methods should be used (self-review of codes and logs, consistency review with other 
data sets and within the report, etc.).  
20.0 
CONFLICT OF INTEREST 
The independence of this study from any actual or perceived influence, such as by the medical 
device industry, is critical.  Therefore, any actual conflict of interest of persons who have a 
role in the design, conduct, analysis, publication, or any aspect of this trial will be disclosed 
and managed. Furthermore, persons who have a perceived conflict of interest will be required 
to have such conflicts managed in a way that is appropriate to their participation in the design 
and conduct of this trial.  The Sponsor has established procedures for all Investigators to 

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disclose all conflicts of interest and will establish a mechanism for the management of all 
reported dualities of interest. 
21.0 
CLINICAL INVESTIGATION PLAN MODIFICATIONS 
Modifications to this CIP may be necessary to protect the safety of the subjects and integrity 
of the data. In collaboration with the Investigator(s), modifications will be documented and 
submitted for ethical and regulatory approval (as required) prior to implementation. All 
changes will be evaluated for impact per Sponsor standard operating procedures (SOPs). 
Modifications will be considered implemented after all ethical and regulatory approvals (as 
required) are received and all key Sponsor and site staff has been trained.  
22.0 
PERIODIC REVIEWS 
Ongoing reviews by IRB/EC are required for the duration of the clinical study.  The 
Investigator will comply with local IRB/EC requirements for ongoing reviews, at a minimum 
annually.  The Sponsor will provide an annual study report to participating Investigators. 
23.0 
INSURANCE 
The Sponsor shall provide clinical study related insurance covering the reasonable, and 
necessary costs of diagnostic, therapeutic and medical treatment including hospitalization 
costs (treatment costs) for such participant injuries following the administration or use of the 
study device(s) in accordance with this clinical investigational plan and in accordance with 
the national regulations.  The Sponsor may reimburse the institution and/or study participants 
for treatment costs depending on who incurred such treatment costs.  The Sponsor will not be 
responsible for paying for or reimbursing treatment costs if (i) the injury is attributable to the 
negligence or misconduct of any agent or employee of the institution or Investigator, or the 
failure of such persons to comply with a study protocol, (ii) the treatment costs are covered by 
the study participant’s medical or hospital insurance coverage, or (iii) the treatment costs 
arose as a result of the treatment of normal progression of the study participant’s disease or 

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injuries resulting from interventions that the study participants would have incurred had they 
not participated in the study.  
24.0 
PUBLIC REGISTRATION AND PUBLICATION 
The Sponsor shall ensure that this study will comply with any required national registration 
requirements.  This study will be conducted in accordance with the applicable publication and 
data sharing policies and regulations.   
25.0 
BIBLIOGRAPHY 
1. 
Moureau NL, Deschneau M, Pyrek J. Evaluation of the clinical performance of a chlorhexidine 
gluconate antimicrobial transparent dressing. JInfectPrev. 2009;10(Suppl. 1):s13-s17. 
2. 
Timsit JF, Mimoz O, Mourvillier B, et al. Randomized controlled trial of chlorhexidine dressing 
and highly adhesive dressing for preventing catheter-related infections in critically ill adults. 
Am J Respir Crit Care Med. 2012;186(12):1272-1278. 
3. 
Scheithauer S, Lewalter K, Schroder J, et al. Reduction of central venous line-associated 
bloodstream infection rates by using a chlorhexidine-containing dressing. Infection. 
2014;42(1):155-159. 
4. 
Maunoury F, Motrunich A, Palka-Santini M, Bernatchez SF, Ruckly S, Timsit J-F. Cost-
Effectiveness Analysis of a Transparent Antimicrobial Dressing for Managing Central Venous 
and Arterial Catheters in Intensive Care Units. PLoS One. 2015;10(6):e0130439. 
5. 
Eyberg CI, Pyrek J. A controlled randomized prospective comparative pilot study to evaluate 
the ease of use of a transparent chlorhexidine gluconate disk in healthy volunteers. JAVA. 
2008;13(3):112-117. 
6. 
Olson C, Heilman JM. Clinical performance of a new transparent chlorhexidine gluconate 
central venous catheter dressing. JAVA. 2008;13(1):13-19. 
7. 
Maryniak K. Clinical performance and nursing satisfaction of a transparent chlorhexidine 
gluconate IV securement dressing with peripherally inserted central catheters. JAVA. 
2009;14(4):200-203. 
8. 
Moureau NL, Deschneau M, Pyrek J. Evaluation of the clinical performance of a chlorhexidine 
gluconate antimicrobial transparent dressing. JInfectPrev. 2009;10(Suppl. 1):s13-s17. 
9. 
Pfaff B, Heithaus T, Emanuelsen M. Use of a 1-piece chlorhexidine gluconate transparent 
dressing on critically ill patients. Crit Care Nurse. 2012;32(4):35-40. 

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10. 
Cooper GL, Schiller AL, Hopkins CC. Possible role of capillary action in pathogenesis of 
experimental catheter-associated dermal tunnel infections. J Clin Microbiol 1988;26:8-12. 
11. 
Crnich CJ, Maki DG. The promise of novel technology for the prevention of intravascular 
device-related bloodstream infection. I. Pathogenesis and shortterm devices. Clin Infect Dis 
2002;34:1232-42. 
12. 
Karpanen T.J., Casey A.L., Whitehouse T., Nightingale P., Das I., Elliott T.S.J. Clinical 
evaluation of a chlorhexidine intravascular catheter gel dressing on short-term central venous 
catheters. American Journal of Infection Control (2016), 44:1 (54-60) 
13. 
Meiling Li, Xiaoli Wang, Hongping Qu., Infection-prevention and control interventions to 
reduce colonisation and infection of intensive care unit-acquired carbapenem-resistant 
Klebsiella pneumoniae: a 4-year quasi-experimental before-and-after study. Antimicrobial 
Resistance and Infection Control(2019),8:8 
26.0 
GLOSSARY 
 
Abbreviations 
Definitions
ADE 
Adverse Device Effect
AE
Adverse Events
CHG 
Chlorhexidine Gluconate
CLABSI
Central Line Associated Bloodstream Infections
CRA 
Clinical Research Associate
CRO 
Contract Research Organization
CRBSI 
Catheter Related Blood Stream Infections
CVC 
Central Venous Catheter
DVC 
Deep Venous Catheters
eCRF
electronic Case Report Form
EC
Ethics Committee
EDC 
Electronic Data Capture
FAS
Full Analysis Set
FDA 
Food and Drug Administration
GCP
Good Clinical Practice
ICF 
Informed Consent Form
IFU 
Instruction for Use
NMPA 
National Medical Products Administration
PD
Protocol Deviation
PI
Principal Investigator
PICCO 
Pulse Index Continuous Cardiac Output

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PPS 
Per Protocol Set
RBC 
Red Blood Cell
SADE
Serious Adverse Device Effect
SAE
Serious Adverse Events
SAP
Statistical Analysis Plan
SAS
Statistical Analysis System
SD
Standard Deviation
SMV
Site Monitoring Visit
SOP
Standard Operating Procedure
SS 
Safety Analysis Set
WBC
White Blood Cell
 
27.0 
STUDY-SPECIFIC APPENDICES 
 
 
 

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Appendix A 
REVISION HISTORY 
The purpose of this appendix is to describe modifications made to this document, in detail, 
when moving from Version 1.0 to Version 2.0. 
Overall summary of changes 
Version 2.0: Exclusion Criteria EC-3 and EC-7 
Section modified 
Original text 
Updated text 
1.0 Synopsis- Selection 
of Subjects-EC-3 
7.2-1 Exclusion Criteria 
EC-3 
The patient is assessed by the 
investigator as being at high risk 
of infection, or known to be 
immune-deficient, based on the 
environment, duration and site 
conditions of catheterization. 
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. 
1.0 Synopsis- Selection 
of Subjects-EC-7 
7.2-1 Exclusion Criteria 
EC-7 
The patient is clinically 
diagnosed with sepsis or 
bacteremia. 
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. 
 
 
 
 
 
 
 
 
 
 
 
 

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Appendix B 
 
Evaluation Criteria  
CLABSI/CRBSI evaluation criteria  
CLABSIs: Primary bloodstream infections in hospitalized patients occur during the use or 
within 48 hours after removal of indwelling central venous catheters and are unrelated to the 
presence of infections at other sites. CRBSI: Catheter-induced bloodstream infections are 
primary infections that occur in patients with a central venous catheter and where there is 
laboratory evidence that the catheter is the source of the bloodstream infection.  
Patients who develop infection symptoms such as fever, chills, and/or hypotension after 
catheterization and at least one peripheral venous blood culture positive of bacteremia or 
fungemia without any other obvious sources of bloodstream infection show one of the 
following: semi-quantitative catheter-tip culture ≥15 cfu, while the same microorganism 
(species) is isolated from both the catheter-tip culture and the peripheral blood culture; the ratio 
of bacterial growth (cfu/ml) between quantitative catheter-tip and peripheral blood cultures, 
which are performed concurrently, is greater than 3:1; the positive alarm time of the blood 
specimen is more than 2 hours earlier than that of the peripheral equivalent specimen.  
Diagnostic criteria  
a．Retain the catheter:  
If two sets of blood cultures are positive and present the same species  
• 
In the absence of evidence of other infections, it indicates possible CRBSI;  
• 
If the same pathogen is found in both sets of cultures and the blood culture from 
the catheter reports positive 120 minutes earlier than the one from the peripheral vein: It 
indicates CRBSI if there is no evidence of other infections (it may also indicate CRBSI 
if the difference in time to positivity between the two sets of blood cultures is less than 
120 minutes but have the same identification and drug sensitivity results).  
• 
If both sets of blood cultures are positive, and the bacterial count from catheter 
blood cultures is at least five times higher than that of peripheral venous blood cultures, 

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it indicates possible CRBSI (for manual quantitative blood culture systems) if there is 
no evidence of other infections.  
If only the catheter blood culture tests positive: It will not be a conclusive evidence of 
CRBSI, but may be due to bacterial colonization or contamination during blood specimen 
collection.  
If only the peripheral venous blood culture tests positive: It will not be a conclusive 
evidence of CRBSI; however, if it is Staphylococcus aureus or Candida, in the absence of other 
evidence of infection, it indicates possible CRBSI.  
If both sets of blood cultures are negative: It indicates no CRBSI.  
The reference table is as follows:  
Catheter   
Peripheral 
vein   
Conditions 
  
Judgment of 
results   
+ 
+ 
 
Possible CRBSI  
+ 
+ 
The catheter-tip culture reports 
positive 120 minutes earlier than 
the peripheral vein culture  
Indicating CRBSI   
Catheter bacterial concentration is 
5 times higher than peripheral vein   
+ 
- 
 
Cannot be 
determined   
- 
+ 
 
Cannot be 
determined  
In the case of Staphylococcus 
aureus, or Candida      
Indicating CRBSI   
- 
- 
 
Not CRBSI       
 
b．Removal of catheters:  

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If one or more sets of blood cultures are positive and the catheter-tip culture is positive: 
The detection and drug-sensitivity spectrum analysis indicate the same species in both types of 
cultures: It indicates possible CRBSI;  
If one or more sets of blood cultures are positive and the catheter-tip culture is negative: 
If the cultures are positive for Staphylococcus aureus or Candida and there is no evidence of 
other infections, it indicates possible CRBSI and may require additional positive blood cultures 
of the same organism to reach a conclusion;  
If the blood culture is negative and the catheter-tip culture is positive: It indicates catheter 
colonization, not CRBSI;  
If both sets of blood cultures and end-of-catheter cultures are negative: It indicates no 
CRBSI.  
The reference table is as follows:  
Catheter tip  Peripheral 
vein 1  
Peripheral 
vein 2   
Judgment of results    
+ 
+ 
+ 
Possible CRBSI      
+ 
+ 
- 
- 
+ 
- 
Cultures are positive for 
Staphylococcus aureus or 
Candida and there is no 
evidence of other infections, it 
indicates possible CRBSI             
- 
+ 
+ 
+ 
- 
- 
Catheter-colonizing bacteria  
- 
- 
- 
Not CRBSI                          
 
Lift Scale 
Score 
Description of Sample Lift 
0 
No lift 
1 
1 - 25%
2 
26 - 50%
3 
51 - 75%
4 
76 - 99%

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5
Missing
 
Skin Irritation Scale- Erythema  
Score 
Description of Response 
0 
No Erythema
1 
Very slight erythema (barely perceptible- edges not well defined) 
2 
Well-defined erythema (pale red in color and area definable) 
3 
Moderate erythema (definite red in color and rea definable) 
4 
Severe erythema (beet or crimson in color)
 
Skin Irritation Scale- Edema 
Score 
Description of Response 
0 
No Edema
1 
Very slight edema (barely perceptible edges not well defined)
2 
Well-defined edema (area definable but not raised more than 1 mm) 
3 
Moderate edema (area well definable and raised approximately 1 mm) 
4 
Severe edema (area raised more than 1 mm and extending beyond 
exposure area)
 
Itch 
Score 
Description of Response 
0
No itching 
1
Slight itching
2
Moderate itching
3
Extreme itching: could not stop scratching at any time/ need a treatment