1
3M
™
Tegaderm
™
CHG
Chlorhexidine Gluconate
I.V. Securement Dressing FAQ
2
Contents
Antimicrobial efficacy
Page 3 Is 3M
™
Tegaderm
™
CHG Dressing cleared by the regulatory authorities for catheter-related bloodstream infection (CRBSI)
reduction? How is it classified according to EU Medical Device Directive?
Page 3 Has 3M
™
Tegaderm
™
CHG Dressing been studied to reduce catheter-related bloodstream infections (CRBSI) in multiple
randomised studies?
Page 3 How does a CHG gel pad provide antimicrobial protection? Does it provide 360-degree protection?
Page 3 Does 3M
™
Tegaderm
™
CHG Dressing provide coverage around suture sites?
Page 3 Does 25% weight/weight CHG provide better antisepsis than 2% weight/weight CHG?
Product features and specifications
Page 4 What is the difference between 3M
™
Tegaderm
™
CHG Dressing and BIOPATCH
®
Disks?
Page 4 Does the 3M
™
Tegaderm
™
CHG Dressing gel pad absorb fluid, such as drainage or blood?
Page 4 Is the 3M
™
Tegaderm
™
CHG Dressing adhesive pressure sensitive?
Page 4 Does the 3M
™
Tegaderm
™
CHG Dressing meet the current international requirement of a transparent semi-permeable
membrane? Is it a breathable dressing?
Page 5 Does 3M
™
Tegaderm
™
CHG Dressing meet the definition of an engineered stabilisation device (ESD)?
Page 5 When was 3M
™
Tegaderm
™
CHG Dressing originally launched for sale? Have there been any changes or improvements?
Application and removal
Page 6 Can 3M
™
Tegaderm
™
CHG Dressing be used for peripheral IVs (PIV)?
Page 6 When do I need to change the 3M
™
Tegaderm
™
CHG Dressing?
Page 6 What is the best way to remove 3M
™
Tegaderm
™
CHG Dressing?
Page 6 Can 3M
™
Tegaderm
™
CHG Dressing be left on for 10 days?
Page 7 Can a skin antiseptic be used with 3M
™
Tegaderm
™
CHG Dressing?
Page 7 After application of a skin antiseptic, how long should the site be allowed to dry before application of the
3M
™
Tegaderm
™
CHG Dressing to avoid skin irritation and edge-lift?
Page 7 What should I do if I see skin maceration or moisture-related irritation under the 3M
™
Tegaderm
™
CHG Dressing gel pad?
Patient populations and procedures
Page 8 Can 3M
™
Tegaderm
™
CHG Dressing be used on infants?
Page 8 Can 3M
™
Tegaderm
™
CHG Dressing be used in BMT/Oncology?
Page 8 Can 3M
™
Tegaderm
™
CHG Dressing be used during radiation therapy?
Page 8 Can I use 3M
™
Tegaderm
™
CHG Dressing on diaphoretic patients?
Page 8 Can 3M
™
Tegaderm
™
CHG Dressing be used to treat a site infection?
Page 8 Can 3M
™
Tegaderm
™
CHG Dressing be used to treat a wound?
Compatibility
Page 9 What other devices can 3M
™
Tegaderm
™
CHG Dressing be used with?
Page 9 Does 3M
™
Tegaderm
™
CHG Dressing fit with a StatLock
®
PICC Plus Stabilization Device?
Page 9 Can I use 3M
™
Tegaderm
™
CHG Dressing together with 3M
™
Cavilon
™
No Sting Barrier Film?
Page 9 Is 3M
™
Tegaderm
™
CHG Dressing MRI compatible?
Page 9 Can 3M
™
Tegaderm
™
CHG Dressing be used in a hyperbaric chamber?
3
Question Answer
Is 3M
™
Tegaderm
™
CHG Dressing
cleared by the regulatory authorities for
catheter‑related bloodstream infection
(CRBSI) reduction? How is it classified
according to EU Medical Device Directive?
3M
™
Tegaderm
™
CHG Dressing is the only transparent securement dressing proven
to reduce CRBSI and vascular catheter colonization that aligns with evidence-based
guidelines and practice standards. 3M received CE mark on expanded claims in 2014
and cleared by FDA in U.S. in 2017. Tegaderm CHG Dressing has been shown to reduce
the incidence of CRBSI and catheter colonisation in a large, randomised, controlled
clinical trial for both short-term central venous (CVC) and arterial catheters.
1
According to Medical device directive 93/42/EEC Tegaderm CHG Dressing
is classified in EU as medical device Class III.
Has 3M
™
Tegaderm
™
CHG Dressing
been studied to reduce catheter‑related
bloodstream infections (CRBSI) in multiple
randomised studies?
3M
™
Tegaderm
™
CHG Dressing has multiple randomised controlled trials (RCT).
In addition to the Timsit 2012 RCT for short-term central venous (CVC) and arterial
catheters,
1
there is an RCT on dialysis patients
2
and another on a neutropenic patient
population.
3
Additionally, there are two meta-analyses that include Tegaderm CHG
Dressing.
4,5
A meta-analysis is the highest level of clinical evidence, referencing
multiple RCTs.
Review the full 3M
™
Tegaderm
™
CHG Dressing clinical evidence summary.
How does a CHG gel pad provide
antimicrobial protection?
Does it provide 360‑degree protection?
CHG is an active antimicrobial component of the 3M
™
Tegaderm
™
CHG Dressing gel
pad. The gel is composed of water, 2% chlorhexidine gluconate and other polymers. The
aqueous nature of the gel pad and CHG allows for immediate antimicrobial action upon
application to skin. In four clinical studies, the CHG gel pad has been shown to provide
complete antimicrobial protection on and under a vascular catheter segment.
6,7,8,9
According to two published studies, Tegaderm CHG Dressing provides better
antimicrobial protection compared to BIOPATCH
®
Disks.
10,11
Does 3M
™
Tegaderm
™
CHG
Dressing provide coverage
around suture sites?
Current international guidelines recognise sutures as potential sources of infection
and central venous catheter (CVC) complications.
12
3M
™
Tegaderm
™
CHG Dressing
is effective where the CHG gel pad is in contact with the skin and its surrounding
inhibition zone. According to one study, Tegaderm CHG Dressing reduces the number
of microorganisms at the insertion site, suture site, sutures and catheter surface.
7
Note: Tegaderm CHG Dressing is not indicated to reduce bacterial colonisation
of sutures and suture sites. No clinical correlations are intended with in vitro testing.
Does 25% weight/weight CHG
provide better antisepsis than
2% weight/weight CHG?
According to international guidelines, segments regarding the pathogenesis
of a catheter-related bloodstream infection (CRBSI), migration of skin micro-organisms
at the insertion site is considered as a major contamination route.
12,20,22
3M
™
Tegaderm
™
CHG Dressing has been demonstrated to be as effective, or better at reducing skin
flora on healthy subjects than BIOPATCH
®
Disks.
10,11
Tegaderm CHG Dressing has
a concentration of 2% CHG weight by weight and does not require additional
moisture for activation.
Antimicrobial efficacy
Return to Contents page
4
Question Answer
What is the difference between
3M
™
Tegaderm
™
CHG Dressing
and BIOPATCH
®
Disks?
3M
™
Tegaderm
™
CHG Dressing is the only transparent securement dressing proven to
reduce catheter-related bloodstream infections (CRBSI) and vascular catheter colonization
that aligns with evidence-based guidelines and practice standards. The dressing provides
four essential elements you need to protect IV sites in one integrated, easy-to-use product
including infection reduction, site visibility, consistent application and catheter securement.
3M
™
Tegaderm
™
CHG Dressing can be used to cover and protect catheter sites and
to secure devices to skin. Common applications include securing and covering IV catheters,
other intravascular catheters and percutaneous devices. Tegaderm CHG Dressing is
intended to reduce skin colonisation and catheter colonisation and to suppress regrowth of
microorganisms commonly related to bloodstream infections. Tegaderm CHG is intended to
reduce catheter-related bloodstream infections (CRBSI) in patients with central venous or
arterial catheters.
For more information, visit engage.3M.com/chgcomparison.
Does the 3M
™
Tegaderm
™
CHG Dressing
gel pad absorb fluid, such as drainage
or blood?
Yes. 3M
™
Tegaderm
™
CHG Dressing absorbs blood, sweat and exudates
(8x its weight in saline and 3x its weight in blood) and still maintains antimicrobial
effectiveness. As the gel pad absorbs fluid, it swells and becomes larger in size.
Drainage should remain contained within the gel pad without obscuring visualisation
of the catheter insertion site. Apply an external gauze pressure dressing with tape
to help reduce drainage on newly placed catheters.
According to 2014 Epic3 National Evidence Based Guidelines: IVAD19, use a sterile gauze
dressing if a patient has profuse perspiration or if the insertion site is bleeding or leaking,
and change when inspection of the insertion site is necessary or when the dressing becomes
damp, loosened or soiled. Replace with a transparent semi-permeable dressing as soon as
possible. Class D/GPP 20.
20
Tegaderm CHG Dressing is not intended to be used on sites
which are actively oozing or bleeding, or large amounts of moisture or drainage. Tegaderm
CHG Dressing has not been tested in combination with hemostatic agents
or skin adhesives regarding safety and efficacy.
Is the 3M
™
Tegaderm
™
CHG Dressing
adhesive pressure sensitive?
Yes, firm pressure should be applied to the entire dressing surface, before and after removal
of the paper frame to enhance adhesion.
Does the 3M
™
Tegaderm
™
CHG
Dressing meet the current international
requirement of a transparent
semi‑permeable membrane?
Is it a breathable dressing?
3M
™
Tegaderm
™
CHG Dressing consists of a gel pad containing CHG integrated with
a Tegaderm Transparent Film Dressing. Moisture readily passes through the gel to the
dressing film to be released as vapour. The pattern-coated adhesive technology enhances
the ability of moisture vapour transfer. The Tegaderm Film acts as a selective filter, providing
a barrier to external liquids, bacteria, and viruses* while allowing water vapour, oxygen, and
carbon dioxide to be easily exchanged.
* In vitro testing shows that the film provides a barrier against viruses 27 nm in diameter
or larger while the dressing remains intact without leakage.
Product features and specifications
Return to Contents page
5
Product features and specifications continued
Question Answer
Does 3M
™
Tegaderm
™
CHG Dressing
meet the definition of an engineered
stabilisation device (ESD)?
Yes, 3M
™
Tegaderm
™
CHG Dressing meets the definition of an ESD, as reflected
in the 2016 updates to the Infusion Nurses Society (INS) Standards of Practice.
13
Refer to securement features below.
When was 3M
™
Tegaderm
™
CHG
Dressing originally launched for sale?
Have there been any changes
or improvements?
As a leader in innovation, 3M is continuously improving its products based on science and
customer insights. 3M
™
Tegaderm
™
CHG Dressing was first launched for sale
in 2008. The breathability of the dressing was improved in 2010. It was again redesigned
in 2016 with improved breathability, conformability, notches and tape strips. In 2019,
3M introduced a product enhancement specific to Tegaderm CHG I.V. Securement
Dressing 1657R to help conform around large-bore catheters and aid with removal.
This design upgrade introduces perforations on the keyhole notch and on the
securement tape strip as pictured below.
Conforming edge border
Uses technology designed
to reduce edge-lift.
Antimicrobial protection
A chlorhexidine gluconate (CHG)
gel pad provides antimicrobial
protection for up to 7 days.
Conforming keyhole notch
A notch allows catheter lumens to fit
better and stay in place. Perforations
allow keyhole notch to conform
around large catheters.
*
A waterproof, sterile
barrier protects against
external contaminants
**
Highly breathable
transparent film.
Large securement tape
strip with notch
Promotes consistent
application and enhances
stabilization. Perforations
on the tape strip can be
opened to aid with dressing
removal.
*
*Perforations apply to Tegaderm
™
CHG Dressing 1657R only.
** In vitro testing shows that the film provides a barrier against viruses 27 nm in diameter or larger while the
dressing remains intact without leakage.
Return to Contents page
6
Question Answer
Can 3M
™
Tegaderm
™
CHG Dressing
be used for peripheral IVs (PIV)?
Yes. There are studies suggesting that PIVs in place for 3–4 days or longer can
be a significant source of contamination from skin flora responsible for catheter-related
bloodstream infections (CRBSI).
14,15,16,17
When do I need to change the
3M
™
Tegaderm
™
CHG Dressing?
In accordance with international guidelines, transparent adhesive dressings for central
venous catheters (CVC), including peripherally inserted central catheters (PICC), should
be changed when the integrity of the dressing is compromised, soiled, moist or loosened
or at least weekly for adults.
12,20,21,22
Indications to change the dressing include:
• If the dressing becomes loose, soiled or compromised in any way
• If the site is obscured or no longer visible
• If there is visible drainage outside the gel pad
• If the dressing appears to be saturated or overly swollen*
* Note: To test if the dressing is fully saturated, lightly press down on a corner of the gel
pad with your finger. If the gel pad remains displaced once your finger is removed, the
dressing should be changed. 3M
™
Tegaderm
™
CHG Dressing gel pad is not intended
to be used to absorb large quantities of blood or fluid.
What is the best way to remove
3M
™
Tegaderm
™
CHG Dressing?
Minimise catheter movement during dressing changes. Remove appropriate tape strips
first. Slowly peel the dressing following the catheter from where it exits the dressing
toward the insertion site using the ‘low and slow’ removal method. To prevent gel pad
from separating from dressing, grasp a corner of the gel pad and the transparent film
between thumb and finger, then apply a sterile fluid (e.g. saline, alcohol pad or antiseptic
swab) between skin and gel pad to help facilitate removal from skin and catheter.
To access all 3M
™
Tegaderm
™
CHG Dressing application and removal videos and
resources, visit www.3M.co.uk/vascularaccess
Can 3M
™
Tegaderm
™
CHG Dressing
be left on for 10 days?
3M
™
Tegaderm
™
CHG Dressing has been shown to effectively inhibit re-growth of skin
flora on healthy subjects for up to 10 days.
6,11
However, consistent with the international
guidelines, the dressing may remain in place up to 7 days and than be changed.
12,13,20,21,22
Application and removal
Click here to access the full 3M
™
Tegaderm
™
CHG Dressing instructions for use.
Return to Contents page
7
Application and removal continued
Question Answer
Can a skin antiseptic be used
with 3M
™
Tegaderm
™
CHG Dressing?
Yes. According to international guidelines, disinfect clean skin with an appropriate antiseptic
before catheter insertion and during dressing changes.
12,20
A ≥ 0.5% chlorhexidine-based
preparation with alcohol is preferred. 3M
™
Tegaderm
™
CHG Dressing is designed to work
with 3M
™
Cavilon
™
No Sting Barrier Film, alcohol, povidone iodine, CHG prep with alcohol
and sterile saline. Use of Tegaderm CHG Dressing has been demonstrated to reduce skin
flora counts on healthy subjects to lower levels than can be achieved with skin preps
alone.
10,11
In addition, antimicrobial protection will be provided continuously at the site for up
to 10 days with Tegaderm CHG Dressing,
6
whereas microbes can triple in volume as quickly
as 24 hours following skin antisepsis using a standard dressing treated with a CHG prep.
18
However, consistent with current international guidelines, the dressings should be changed
at least weekly for adult patients.
12,20,21,22
After application of a skin antiseptic,
how long should the site be allowed
to dry before application of the
3M
™
Tegaderm
™
CHG Dressing
to avoid skin irritation and edge‑lift?
Refer to the Tegaderm CHG Dressing Instructions for use. Let all skin preps dry completely
before applying any dressing.
What should I do if I see skin maceration
or moisture‑related irritation under the
3M
™
Tegaderm
™
CHG Dressing gel pad?
According to a recent 11-year, real-world study, skin reaction rates for CHG gel and CHG
sponge were equivalent at 0.3/1000 catheter days.
19
Excessive moisture results from sweat,
blood/drainage or showering/bathing. 3M
™
Tegaderm
™
CHG Dressing is not intended to
absorb a large amount of drainage or fluid. To prevent moisture-related skin issues, clinicians
should monitor the CHG gel pad for oversaturation. If maceration is observed, remove
the dressing, allow the site to dry completely, apply a gauze and tape dressing per current
international guidelines.
12
The maceration may resolve within a day or so. Once resolved,
transition the patient back to a Tegaderm CHG Dressing.
Click here to access the full 3M
™
Tegaderm
™
CHG Dressing instructions for use.
Return to Contents page
8
Patient populations and procedures
Question Answer
Can 3M
™
Tegaderm
™
CHG Dressing
be used on infants?
Do not use 3M
™
Tegaderm
™
CHG Dressing on premature infants or infants younger than
two months of age. Use of this product on premature infants may result in hypersensitivity
reactions or necrosis of the skin. The safety and effectiveness of Tegaderm CHG Dressing
has not been established in children under 18 years of age. For full prescribing information,
see the Instructions for Use (IFU). Rx Only.
Can 3M
™
Tegaderm
™
CHG Dressing
be used in BMT/Oncology?
Yes. 3M
™
Tegaderm
™
CHG Dressing has been used successfully in BMT/Oncology since
product launch. This patient population is immunocompromised and has fragile, more
permeable skin. Monitor the CHG gel pad for oversaturation and moisture to prevent skin
maceration. Be sure to stress the importance of allowing the preps to dry before applying
the dressing to avoid skin irritation or other complications.
Can 3M
™
Tegaderm
™
CHG Dressing
be used during radiation therapy?
3M
™
Tegaderm
™
CHG Dressing has not been tested for use during radiation therapy.
Can I use 3M
™
Tegaderm
™
CHG
Dressing on diaphoretic patients?
Yes, 3M
™
Tegaderm
™
CHG Dressing is designed to absorb fluid, however it is not intended
to absorb large quantities of fluid. Tegaderm CHG Dressing maintains antimicrobial
effectiveness in the presence of perspiration and other fluids and prevents regrowth of
skin flora. See question ‘When do I need to change the Tegaderm
™
CHG Dressing?’
for more information.
Can 3M
™
Tegaderm
™
CHG Dressing
be used to treat a site infection?
3M
™
Tegaderm
™
CHG Dressing is not indicated for treatment of a suspected
or known site infection.
Can 3M
™
Tegaderm
™
CHG Dressing
be used to treat a wound?
No. 3M
™
Tegaderm
™
CHG Dressing should only be applied to skin which is clean, dry and
intact. Tissue damage or necrosis may result if applied to non-intact skin.
Click here to access the full 3M
™
Tegaderm
™
CHG Dressing instructions for use.
Return to Contents page
9
Compatibility
Question Answer
What other devices can 3M
™
Tegaderm
™
CHG Dressing be used with?
3M
™
Tegaderm
™
CHG Dressing is cleared for use on percutaneous medical devices that
would benefit from microbial reduction. Devices at risk for microbial contamination that
could benefit from Tegaderm CHG Dressing include, but are not limited to, intravenous,
arterial, epidural, extracorporeal membrane oxygenation (ECMO), implanted ports,
surgical drains, cardiac wires (LVADs), subcutaneous therapies, and dialysis catheters.
Tegaderm CHG Dressing is designed for skin applications and not mucosal use.
Does 3M
™
Tegaderm
™
CHG Dressing fit
with a StatLock
®
PICC Plus Stabilisation
Device?
3M
™
Tegaderm
™
CHG Dressing may be used with a StatLock
®
stabilisation device. Ensure
that the gel pad does not overlap onto the plastic wings of the securement device. For
device removal, refer to StatLock
®
stabilisation device instructions for use.
Can I use 3M
™
Tegaderm
™
CHG Dressing
together with 3M
™
Cavilon
™
No Sting
Barrier Film?
Yes. 3M
™
Cavilon
™
No Sting Barrier Film is compatible with 3M
™
Tegaderm
™
CHG
Dressing and can be used to reduce the risk of adhesive trauma. Apply Cavilon No Sting
Barrier Film to the area where the dressing will be applied, avoiding the catheter insertion
site (2 cm) and where the CHG gel pad will be placed. Cavilon No Sting Barrier Film wand
applicators (3343 or 3345) are recommended for IV sites; Cavilon No Sting Barrier Film in
spray form (3346) should not be used for IV sites.
Is 3M
™
Tegaderm
™
CHG Dressing
MRI compatible?
Yes (3M data on file. EM-05-012899).
Can 3M
™
Tegaderm
™
CHG Dressing
be used in a hyperbaric chamber?
Yes (3M data on file. EM-05-012965).
Click here to access the full 3M
™
Tegaderm
™
CHG Dressing instructions for use.
Return to Contents page
10
3M
™
Tegaderm
™
CHG I.V. Securement Dressing
instructions for use
1657R, 1658R, 1659R, 1660R
Description
3M
™
Tegaderm
™
CHG Chlorhexidine Gluconate I.V. Securement
Dressing is used to cover and protect catheter sites and to secure
devices to skin. It is available in a variety of shapes and sizes.
Tegaderm CHG dressing consists of a transparent adhesive
dressing and an integrated gel pad containing 2% w/w
chlorhexidine gluconate (CHG), a well-known antiseptic agent with
broad spectrum antimicrobial and antifungal activity. The gel pad
absorbs fluid. The transparent film provides an effective barrier
against external contamination including fluids (waterproof),
bacteria, viruses* and yeast, and protects the I.V. site.
In vitro testing (time kill and zone of inhibition) demonstrates that
the Tegaderm CHG gel pad in the dressing has an antimicrobial
effect against a variety of gram-positive and gram-negative
bacteria, and yeast.
Tegaderm CHG dressing is transparent, allowing continual
site observation, and is breathable, allowing good moisture vapour
exchange.
*In vitro testing shows that the transparent film of the Tegaderm
™
CHG dressing provides
a viral barrier from viruses 27 nm in diameter or larger while the dressing remains intact without
leakage. The barrier to viruses is due to the physical properties of the dressing, rather than the
ancillary properties of CHG.
Indications
Tegaderm CHG Chlorhexidine Gluconate I.V. Securement
Dressing can be used to cover and protect catheter sites and
to secure devices to skin. Common applications include central
venous and arterial catheters, other intravascular catheters and
percutaneous devices. Tegaderm CHG Dressing is intended to
reduce skin colonization and catheter colonization and to suppress
regrowth of microorganisms commonly related to bloodstream
infections. Tegaderm CHG is intended to reduce catheter-related
bloodstream infections (CRBSI) in patients with central venous
or arterial catheters.
Warnings
Do not use Tegaderm CHG dressings on premature infants
or infants younger than 2 months of age. Use of this product
on premature infants may result in hypersensitivity reactions
or necrosis of the skin.
The safety and effectiveness of Tegaderm CHG dressings has
not been evaluated in children under 18 years of age. For external
use only. Do not allow this product to contact ears, eyes, mouth
or mucous membranes. Do not use this product on patients with
known hypersensitivity to chlorhexidine gluconate.
The use of chlorhexidine gluconate containing products has
been reported to cause irritations, sensitisation, and generalised
allergic reactions. If allergic reactions occur, discontinue use
immediatly, and if severe, contact a physician.
Hypersensitivity reactions associated with topical use
of chlorhexidine gluconate have been reported in several countries.
The most serious reactions (including anaphylaxis) have occurred
in patients treated with lubricants containing chlorhexidine
gluconate, which were used during urinary tract procedures.
Caution should be used when using chlorhexidine gluconate
containing preparations, and the patient should be observed
for the possibility of hypersensitivity reactions.
Precautions
Tegaderm CHG dressing should not be placed over
infected wounds. It is not intended to be used as a treatment
of percutaneous device-related infections.
In the case of clinical wound infection, systemic antibacterials
should be used if indicated.
Any active bleeding at the insertion site should be stabilised before
applying the dressing.
Do not stretch the dressing during application. Mechanical skin
trauma may result if the dressing is applied with tension.
The skin should be clean, dry and free of detergent residue. Allow
all preps and protectants to dry completely before applying the
dressing to prevent skin irritation and to ensure good adhesion.
Do not reuse. Reuse may result in compromising product integrity
and lead to device failure.
Clinical trial results: a randomised, controlled clinical trial
consisting of 1879 subjects with 4163 central venous and arterial
catheter insertion sites was conducted at 11 hospitals.
1
Results
showed that the use of Tegaderm CHG resulted in a statistically
significant 60% reduction in the incidence of catheter-related
bloodstream infections (P=0.02). Study results also demonstrate
a statistically significant reduction in skin colonization (P<0.001)
and catheter colonization (P<0.0001) in the chlorhexidine
vs. non-chlorhexidine group.
Variable Non‑chlorhexidine vs.
chlorhexidine dressings
(941 patients/2055 catheters vs.
938 patients/2108 catheters)
Catheter‑related bloodstream infection
Incidence densities
(n per 1000 catheter-days)
1.3 vs. 0.5
Hazard ratio 0.402 [0.186 to 0.868], P=0.02
Catheter colonization
Incidence densities
(n per 1000 catheter-days)
10.9 vs. 4.3
Hazard ratio 0.412 [0.306 to 0.556], P<0.0001
1 Timsit JF et al Randomised 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; 186:1272–1278
Instructions for use
Failure to follow the manufacturer’s instructions for use may result
in complications including skin irritation and/or maceration.
Dressing selection: choose a dressing large enough to provide
at least one inch margin of adherence on dry, healthy skin around
the catheter site.
Site preparation: prepare the site according to institution protocol.
Clipping of hair at the site may improve dressing adhesion.
Shaving is not recommended. The skin should be clean, dry and
free of detergent residue. Allow all preps and protectants to dry
completely before applying the dressing to prevent skin irritation
and to ensure good adhesion. Any active bleeding at the insertion
site should be stabilised before applying the dressing.
Return to Contents page
11
3M
™
Tegaderm
™
CHG I.V. Securement Dressing
instructions for use continued
1657R, 1658R, 1659R, 1660R
Application
1 Open package and remove sterile dressing.
2 Peel liner from dressing, exposing adhesive surface.
3 Avoid stretching the dressing during application to reduce the
risk of mechanical skin trauma.
4 Centre the gel pad over the catheter insertion site. Apply firm
pressure to entire dressing starting in the centre to the outer
frame edges to enhance adhesion.
5 Slowly remove frame while smoothing down transparent film
dressing edges.
6 Smooth the transparent film dressing from the center towards
the dressing edges, using firm pressure to enhance adhesion.
7 After dressing has been applied, apply the sterile tape strip(s) to
further secure I.V. tubing or to stabilise catheter. Refer to figures
on packaging.
8 Document dressing change information on label according
to facility protocol. Remove label from frame and place on
dressing.
Site care
1 The site should be observed daily for signs of infection or other
complications. If infection is suspected, remove the dressing,
inspect the site directly, and determine appropriate medical
intervention. Infection may be signaled by fever, pain, redness,
swelling, or unusual odor or discharge.
2 Inspect the dressing daily and change the dressing as necessary,
in accordance with facility protocol; dressing changes should
occur at a minimum of every 7 days, per current Centers for
Disease Control and Prevention (CDC) recommendations.
Dressing changes may be needed more frequently with highly
exudative sites.
The Tegaderm CHG dressing should be changed as necessary:
• If the dressing becomes loose, soiled or compromised
in any way
• If the site is obscured or no longer visible
• If there is visible drainage outside the gel pad
• If the dressing appears to be saturated or overly swollen
• To test if the dressing is fully saturated, lightly press down on
a corner of the gel pad with your finger. If the gel pad remains
displaced once your finger is removed, the dressing should be
changed
Note: Tegaderm CHG dressing is not designed to absorb large quantities of blood or fluid.
Removal
Stabilise catheter during removal of the Tegaderm CHG dressing.
1 Remove documentation label and securement tape strip(s) from
top of dressing.
2 Using a low and slow removal technique, start removing the
dressing from where the catheter or tubing exits the dressing
toward the catheter insertion site. Avoid skin trauma by peeling
the dressing back, rather than pulling it up from the skin.
3 When the CHG gel pad is exposed, grasp a corner of the
gel pad and the transparent film dressing between thumb
and finger.
4 Apply sterile alcohol swabs or wipes, or sterile solutions
(i.e., sterile water or normal saline) between gel pad and
skin to facilitate removal of the gel pad dressing. If needed,
a medical adhesive solvent can be used to help remove the
dressing border.
5 Continue the low and slow removal method until the dressing
is completely removed.
Shelf life and storage information
For best results, store in a cool, dry place. For shelf life, refer to the
expiration date on the package.
Sterility of the dressing is guaranteed unless individual package
is damaged or open.
For further information contact your local 3M representative
or contact us at www.3M.com and select your country.
Catalogue
number
Dressing
size
Average amount of CHG per dressing
(mg based on gel pad size)
1657R 8.5cm x 11.5cm 45
1658R 10cm x 12cm 45
1659R 10cm x 15.5cm 78
1660R 7cm x 8.5cm 15
Explanation of symbols
Not made with natural rubber latex
Caution, see instructions for use
Do not use if package is damaged or open
Do not reuse
Use by date
Batch code
Manufacturer
Sterilised using ethylene oxide
Do not re-sterilise
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12
Important safety information for 3M
™
Tegaderm
™
CHG Dressing
References
Additional resources
Do not use Tegaderm CHG Dressing on premature infants or infants younger than two months of age. Use of this product on premature
infants may result in hypersensitivity reactions or necrosis of the skin. The safety and effectiveness of Tegaderm CHG Dressing
has not been established in children under 18 years of age. For full prescribing information, see the Instructions for use (IFU).
3M.com/IVtraining 3M Health Care YouTube Channel 3M Health Care Academy
1 Timsit JF, Mimoz O, Mourvillier B, et al. Randomised 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.
2 Apata IW, Hanfelt J, Bailey JL, Niyyar VD. Chlorhexidine-impregnated transparent
dressings decrease catheter-related infections in hemodialysis patients: a quality
improvement project. J Vasc Access. 2017;18(2):103–108.
3 Biehl LM, Huth A, Panse J, et al. A randomised trial on chlorhexidine dressings for
the prevention of catheter-related bloodstream infections in neutropenic patients.
Ann Oncol. 2016;27(10):1916–1922.
4 Wei L, Li Y, Li X, Bian L, Wen Z, Li M. Chlorhexidine-impregnated dressing for the
prophylaxis of central venous catheter-related complications: a systematic review
and meta-analysis. BMC Infect Dis. 2019;19:(1). https://bmcinfectdis.biomedcentral.
com/articles/10.1186/s12879-019-4029-9.
5 Safdar N, O’Horo JC, Ghufran A, et al. Chlorhexidine-impregnated dressing for
prevention of catheter-related bloodstream infection: A meta-analysis.
Crit Care Med. 2014;42(7):1703–1713.
6 Schwab D, et al. Antimicrobial activity of a CHG-impregnated gel pad for I.V. site
protection. Poster presented at: the conference of Infusion Nursing Society;
May, 2008.
7 Karpanen TJ, Casey AL, Whitehouse T, Nightingale P, Das I, Elliott TS.
Clinical evaluation of a chlorhexidine intravascular catheter gel dressing
on short-term central venous catheters. Am J Infect Control. 2016;44(1):54–60.
8 Karpanen TJ, Casey AL, Conway BR, et al. Antimicrobial activity of a chlorhexidine
intravascular catheter site gel dressing. J Antimicrob Chemother.
2011;66(8):1777–1784.
9 3M Data on File. EM-05-002068.
10 Bashir MH, Olson LK, Walters SA. Suppression of regrowth of normal
skin flora under chlorhexidine gluconate dressings applied to chlorhexidine
gluconate-prepped skin. Am J Infec Control. 2012;40:344–348.
11 Maki D, Stahl J, Jacobson C, et al. A novel integrated chlorhexidine-impregnated
transparent dressing for prevention of vascular catheter-related bloodstream
infection: A prospective comparative study in healthy volunteers. Poster presented
at: the conference of The Society for Health Care Epidemiology of America;
April, 2008.
12 Centers for Disease Control and Prevention. Guidelines for the Prevention
of Intravascular Catheter-Related Infections, 2011. Available at:
http://www.cdc.gov/hicpac/pdf/guidelines/bsi-guidelines-2011.pdf.
13 Gorski L, Hadaway L, Hagle ME, McGoldrick M, Orr M, Doellman D.
Infusion therapy standards of practice. J Infus Nurs. 2016;39(suppl 1):S1-S159.
14 Trinh TT, Chan PA, Edwards O, et al. Peripheral venous catheter-related
Staphylococcus aureus bacteremia. Infect Control Hosp Epidemiol.
2011;32(6):579–583.
15 Pujol M, Hornero A, Saballs M, et al. Clinical epidemiology and outcomes
of peripheral venous catheter-related bloodstream infections at a
university-affiliated hospital. J Hosp Infect. 2007 Sep;67(1):22–29.
16 Wischnewski N, Kampf G, Gastmeier P, et al. Prevalence of primary bloodstream
infections in representative German hospitals and their association with central and
peripheral vascular catheters. Zentralbl Bakteriol. 1998; 287:93–103.
17 Mermel L. Short-term peripheral venous catheter-related bloodstream infections:
A systematic review. Clin Infect Dis. 2017;65(10):1757–1762.
18 3M data on file. EM-05-305455.
19 Eggimann P, Pagani JL, Dupuis-Lozeron E, et al. Sustained reduction
of catheter-associated bloodstream infections with enhancement of catheter
bundle by chlorhexidine dressings over 11 years. Intensive Care Med. (2019)
45:823–833. https://doi.org/10.1007/s00134-019-05617-x.
20 Loveday HP, Wilson JA, Pratt RJ, et al. epic3: national evidence-based guidelines
for preventing healthcare-associated infections in NHS hospitals in England.
J Hosp Infect. 2014;86 Suppl 1:S1-70.
21 Formalised Expert Recommendations: management of vascular approaches in RFE
resuscitation under the aegis of the SRLF (French Language Resuscitation Society),
April 2019.
22 Prevention of infections caused by vascular catheters. Bundesgesundheitsbl 60,
171-206 (2017). https://doi.org/10.1007/s00103-016-2487-4.
BIOPATCH is a registered trademark of ETHICON, INC.
StatLock is a registered trademark of Becton, Dickinson and Company.
HealthStream is a trademark of HealthStream, Inc.
3M, Cavilon and Tegaderm are trademarks of 3M Company.
© 3M 2020. All rights reserved.
OMG70860.
3M United Kingdom PLC
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LE11 5RB
01509 611611
3M Ireland
The Iveagh Building
The Park
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Dublin 18
Ireland
00 353 (01) 280 3555
To learn more about 3M
™
Tegaderm
™
CHG Dressings, visit us at www.3M.co.uk/vascularaccess,
contact your 3M Medical Solutions representative or call the 3M customer helpline at 0330 053 8938.
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