3M™ Coban™ 2 Layer Compression TherapyDesigned with Intelligent Compression Dynamics

A PRODUCT MONOGRAPH

Engineered forComfort

Designed for Real Life

Compression therapy is the mainstay of treatment for venous leg ulcers (VLUs) and it is generally accepted that poor concordance with compression therapy ultimately affects ulcer healing and recurrence.1

Table of ContentsCompression Therapy Overview

The Importance of Compression Therapy in Healing Venous Leg Ulcers. . . . . . . . . . . . . . . . 4

Overview of the Venous System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Defining the Ideal Compression System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Measuring the Effects of Compression on Lower Limbs . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Ideal Compression Therapy for Patients of all Sizes, Shapes and Lifestyles . . . . . . . . . . . . . 8

Intelligent Compression Dynamics Defined. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Designed to Address Compression Therapy ChallengesDesigned for Effectiveness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Designed to Stay in Place . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Designed for Consistent Application. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Designed for Comfort, Mobility and Daily Living . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

EvidenceClinical Evidence Summaries. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16 – 23

Ordering Information Ordering Chart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

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The Importance of Compression Therapy in Healing Venous Leg UlcersThe Costs are HighVenous leg ulcers are the most serious complication of venous hypertension. Epidemiological studies suggest that between 1–2% of the population will develop a venous ulcer at some time. These wounds have a high rate of recurrence and are considered to be a major health care problem. The annual cost of treating venous ulcers to the U.S. healthcare system is estimated at $2.5–3.5 billion.2 Up to one-third of treated patients experience four or more episodes of recurrence.3

Venous Leg Ulcers Reduce Patient Quality of Life Venous leg ulcers significantly reduce patient quality of life. In fact, 81% of patients with venous leg ulcers experience decreased mobility, and 50% report severely limited mobility. As a result, 68% of patients with impaired mobility experience fear, anger, depression and social isolation.4

Compression Therapy is Proven EffectiveCompression therapy has been recorded in history from as early as the time of Hippocrates (460–377 BC)5 and is considered the standard of care for treating venous hypertension and venous ulceration. The goal of compression therapy is to reduce edema in the lower extremities by:

• Reducing blood pressure in the superficial venous system

• Aiding venous return of blood to the heart by increasing the velocity of flow in the deep veins

• Reducing the pressure differences between the capillaries and the tissue to prevent backflow

Compression therapy has been shown to improve the lives of patients by significantly reducing edema, increasing mobility and reducing pain.

3M: Advancing the Science of Compression Therapy3M advanced the science of compression therapy by creating materials engineered to deliver Intelligent Compression Dynamics to provide comfortable, therapeutic compression for the treatment of venous leg ulcers.

Compression Therapy Overview

Challenges with Current Compression SystemsClinician-Related Challenges• Clinicians have varying levels of experience applying

compression bandages; training may be informal, inadequate or non-existent

• Application techniques are different for each product

• It can be difficult to attain the appropriate stretch (30–70%) for some elastic bandage systems

• Clinicians may be concerned about potential for injury from bandages, and therefore, may not apply enough compression

• Clinicians know the systems are often poorly tolerated by their patients because they’re bulky, uncomfortable or painful

• Application and removal of zinc paste bandages can be messy; application and removal of four-layer systems can be time consuming

• Some patients require an “unscheduled” clinic visit between regularly scheduled visits, placing additional burden on the clinician and healthcare resources

Patient-Related Challenges• If a compression system is painful, hot or too bulky to

wear with normal shoes, many patients remove the bandages and interrupt therapy

• Some patients wait for their next clinic appointment without wearing any compression bandages

• By removing or not wearing the bandages, patients prolong the healing of the ulcers

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Overview of the Venous SystemThe venous system comprises several components that work together to return blood to the heart:

• veins (superficial, perforator and deep)

• one-way valves

• calf and foot pump mechanisms

The superficial veins act as a collection system returning blood via small perforator veins back to the heart through the deep veins, which lie within muscle and fascia. Veins have thin muscular walls that easily dilate to accommodate venous blood and one-way valves that prevent backflow (reflux). Venous circulation is assisted by the action of foot and calf muscles acting as “pumps” squeezing the blood back to the heart via contraction (muscle systole) and relaxation (muscle diastole).

Normal Venous PressureBlood pressure within the veins is usually low and is mainly determined by the weight of the blood column from the foot to the heart. Venous pressure is affected by gravity, body position and movement. When lying down, feet are level with the heart so pressures are low, typically ranging between 0 and 10 mmHg. When sitting, pressures increase to around 40 mmHg. When standing, the pressures are higher, closer to 90 mmHg. Flexing foot or calf muscles propels the blood to the heart and the one-way valves prevent reflux.

Venous InsufficiencyDamage to the veins or valves may lead to unrelieved high venous pressure. Over time, venous hypertension causes an upset in the normal balance that keeps fluids in the vessels, causing pooling of fluid in the lower extremities, which results in edema. If not managed, venous hypertension will ultimately result in venous leg ulcers.

Chronic venous insufficiency is a

fairly common condition that affects

2–5% of Americans. In the U.S.,

it has been estimated that venous

ulcers cause the loss of 2 million

working days per year.3

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Defining the Ideal Compression SystemThe ideal compression therapy system has been described in the 2003 European Wound Management Association (EWMA) Position Document as one that:

• provides and maintains clinically effective levels of compression

• enhances calf muscle pump function

• is non-allergenic

• is easy to apply

• facilitates ease of training

• is conformable and comfortable

• is durable

The Ideal Physiology: Giraffe SkinThe distance between a giraffe’s heart and feet is twice that of humans, giving it venous blood pressure twice as high as ours. Giraffes also have relatively smaller calf muscles, do not have moving or bending toes and their ankle joint movement is minimal—yet they do not experience venous hypertension.

So why don’t giraffes suffer from edema?The secret is in the skin. Giraffe skin is extremely tough, fibrous and non-elastic. It creates a rigid sleeve that maximizes the effect of every muscle movement—big and small, moving and resting—to optimize venous return.6,7

3M applied this same principle when developing the 3M™ Coban™ 2 Layer Compression Systems by designing materials that work together to create a rigid sleeve, much like giraffe skin, to consistently provide the right amount of compression to reduce edema.

“A rigid sleeve with an anatomical

fit around ‘the subject’s’ leg, which

stays in place and provides a well

tolerated pressure in rest” defines an

ideal compression system.

– Jan Schuren, RgN, BN, MSc, inventor of 3M Coban 2 Layer Compression System

Anatomical illustration of giraffe and human showing location of the heart

Compression Therapy Overview

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Measuring the Effects of Compression on Lower LimbsNew methods and devices are available to measure sub-bandage pressures to understand muscle dynamics supported by the applied compression system.

Figure 1: PicoPress® Compression Measurement System by Microlab Elettronica. Dynamic test showing effects of compression bandage on lower limb under static and dynamic conditions.

A B

DE

C

A. LAY = Resting Pressure

B. STAND = Standing Pressure

C. EXERCISE = Working Pressure

D. Static Stiffness Index (SSI)

E. Amplitudes

Figure 1 illustrates pressure values taken from a sensor placed at the B1 site, under a compression bandage, while the subject is resting, standing and flexing the foot. The B1 site is defined as the area at which the Achilles tendon changes into the calf muscles (10–15 cm proximal to the medial malleolus). The wave on the screen reflects the amplitudes generated by normal muscle activity.

Resting PressureIn the laying or sitting with leg elevated position (LAY), the pressure exerted by the compression bandage against the limb is about 40 mmHg—commonly accepted as the pressure required to counteract the hydrostatic pressure in the veins.8 This is referred to as resting pressure.

Standing PressureIn the standing position (STAND), there is a peak in pressure representing the muscle contraction against the bandage. The difference between the standing and resting pressures has been defined as the Static Stiffness Index (SSI).9 This measurement is used to define the elasticity of a bandage and predict its ability to optimize muscle movements. A bandage with an SSI greater than 10 provides stiffness to keep muscle forces inside the bandage and correlates with optimal peak amplitudes of muscle activity.

Working PressureWhen flexing the foot (EXERCISE), the difference between the high and low pressure points reflect contraction (high) and relaxation (low) of the muscles. These amplitudes are the working pressures required to reduce venous hypertension.

Ideal Compression Therapy for Patients of all Sizes, Shapes and Lifestyles3M™ Coban™ 2 Layer Compression Systems are designed to deliver comfortable, therapeutic compression for the treatment of venous leg ulcers, lymphedema and other conditions where compression therapy is appropriate.

3M™ Coban™ 2 Layer Compression System Therapeutic Compression Designed for Everyday ComfortCoban 2 Layer Compression System, with the purple packaging, provides high compression (35–40 mmHg) and is ideal for treating the majority of patients with ABPI greater than or equal to 0.8.

In a randomized, controlled trial comparing slippage, health related quality of life (HRQoL), patient preference and wound healing to Profore,™ Coban 2 Layer Compression System provided significantly less slippage, and was preferred by 72% of patients.10

3M™ Coban™ 2 Layer Lite Compression System Designed for Patients Less Tolerant of CompressionCoban 2 Layer Lite Compression System, with the green packaging, provides the same working dynamics as the original, with a 25% reduced resting pressure, making it a safe, comfortable and effective option for patients less tolerant of compression therapy,11 including:

• those who have mixed etiology with an ABPI greater than or equal to 0.5

• are new to compression, or where tolerance is not known

• are frail or less mobile

Designed with Clinicians in Mind• Designed to reduce application variability for consistent compression every time12

• Application is quick and easy to teach and learn12

• Conformable to accommodate difficult shapes and sizes13

• Materials are safe and well tolerated13

• Easier, faster and less messy to apply than zinc paste bandages14

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Compression Therapy Overview

SSI –

– Amplitudes

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— Coban 2 Layer— Coban 2 Layer Lite

SSI –– Amplitudes

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Intelligent Compression Dynamics DefinedIn compression, dynamics refers to the difference between high and low working pressure points, reflecting intermittent changes in pressure caused by the patient’s own muscle movement. Inelastic or rigid compression systems generate larger dynamics, or amplitudes, and therefore, more effective compression. 3M advanced the science of compression therapy by designing materials engineered with Intelligent Compression Dynamics to create a conformable, inelastic sleeve that stays in place and is comfortable to wear. These Intelligent Compression Dynamics support the patient’s muscle movements for effective venous return and reduction of edema.

Dynamics of Coban 2 Layer Compression SystemsAmplitudes are unique to each person. The following illustrations simulate the amplitudes generated by applying Coban 2 Layer System and Coban 2 Layer Lite System. As illustrated in Figures 2 and 3, Coban 2 Layer Lite System provides working pressures similar to the original, but with a 25% reduced resting pressure, making it a safe, effective, comfortable option for patients less tolerant of compression.

Figure 2: This illustration represents the SSI and amplitudes of a patient with well-developed muscle strength. Peak amplitudes are approximately 45 mmHg.

Figure 3: This illustration represents the SSI and amplitudes of a patient with less muscle tone. At about 25 mmHg, the amplitudes are lower than the original, but still reflect effective compression with an SSI well above 10.

Amplitudes of a Patient with Larger Muscles

Amplitudes of a Patient with Smaller Muscles

Designed to Address Compression Therapy Challenges

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Designed to Address Compression Therapy Challenges While compression therapy is considered the standard of care for treating

chronic edema, there are a number of clinician- and patient-related

challenges with traditional multi-layer systems, including:

• Painful slipping and bunching often causing patients to remove their

bandages, which can disrupt healing

• Inconsistency in application techniques, resulting in variable pressures

and results

• Bulkiness, which can impede patients from wearing normal footwear

and clothing, negatively impacting their activities of daily living

3M™ Coban™ 2 Layer Compression Systems were designed to overcome

these challenges to promote patient concordance and the potential

for more effective treatment. The patented interlocking materials were

designed to reduce the potential for uncomfortable slipping or bunching,

minimize application variability for consistent compression every time,

and be worn with normal clothing and footwear, enabling patients

to carry on with everyday life.

Designed for EffectivenessWhile compression therapy is not new, there is an emerging body of evidence providing a more contemporary understanding of the pathophysiology of compression. Research has identified that the effectiveness of a compression bandage can be predicted by the Static Stiffness Index (SSI). Bandages with an SSI greater than 10 provide enough support to keep the muscle contraction and relaxation forces inside the bandage. Many compression systems require multiple layers to achieve adequate stiffness, but as a result, impede a patient’s mobility and quality of life by creating thick, bulky bandages that slip down.

Breakthrough Research in Materials ScienceHistorically, Laplace’s Law has been used to explain the effects of compression. However, recent research has shown that the adapted mathematical equation seldom predicts the sub-bandage pressures achieved by compression bandages.15

Current breakthrough research has demonstrated that Pascal’s Law provides a better understanding of the effects of compression.16 Pascal’s Law states that when pressure is applied on a fluid (a muscle or muscle group) in a closed container (fascia and compression bandage), the pressure is transmitted equally and undiminished in all directions throughout the fluid.

Coban 2 Layer Compression Systems Support Pascal’s LawThis principle has been demonstrated in a controlled laboratory study with 12 healthy subjects.16 Two sensors were placed distally and proximally on the anterior tibilias muscle with the third at the B1 position. Coban 2 Layer Compression System was then applied to the limb, providing a rigid sleeve, or closed container. A blood pressure cuff applied over the proximal sensor was inflated in 20 mmHg increments.

11

Figure 4: Percentage change in pressure is similar for all sensors.

Supporting Evidence: See Clinical Evidence Summaries on pages 17, 20, 21, 22 and 23.

20 mmhg 40 mmhg 60 mmhg 80 mmhg0 mmhg 100 mmHg

60

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% C

hang

e

m. tibialis anterior proximal + cuff

m. tibialis anterior distal

B1

Figure 4 illustrates the effects of Pascal’s Law. The sensors not located under the blood pressure cuff show similar pressure changes at each 20 mmHg increase of pressure to the sensor under the cuff.

Coban 2 Layer Compression System materials were designed to provide a thin, comfortable, conforming sleeve with the required stiffness to distribute muscle contraction forces equally beneath the bandage, thus supporting the muscle pump and reducing edema.

Results from a Controlled Laboratory Study Demonstrating Pascal’s Law

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Designed to Address Compression Therapy Challenges

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0Coban 2 LayerCoban 2 Lite ActicoKTwoProforeProfore LiteProguideShort StretchLong StretchRosidal SysCoban 2 LayerCoban 2 Lite

Light Shading: 24 HoursDark Shading: 48 Hours

Designed to Stay in PlaceIn laboratory studies, other multi-layer systems can provide effective pressures immediately after application, but when patients become mobile the bandages slip and bunch at the ankle within a short period of time.10 This slippage is uncomfortable—even painful—often causing patients to remove the bandages, further reducing the potential for healing. 3M™ Coban™ 2 Layer Compression Systems were designed to stay in place to provide sustained compression during wear.

Materials Designed Not to SlipThe inner comfort layer consists of a latex-free medical grade polyurethane foam laminated to a cohesive non-woven backing. When compressed, the foam grips the skin, and the non-woven backing provides a cohesive surface for the attachment of the outer compression layer. The proprietary interlocking materials cohere to each other, creating a rigid sleeve that conforms to the limb and reduces potential for uncomfortable slipping or bunching.

Reduced Slippage Provides Sustained CompressionIn a randomized, controlled laboratory study designed to understand the performance characteristics of 10 compression systems, 60 healthy volunteers participated in a 48-hour wear test.11 Each participant had two systems applied—a different system on each leg—by experts from the United Kingdom, Germany and the Netherlands. 3M™ Coban™ 2 Layer Compression System and 3M™ Coban™ 2 Layer Lite Compression System had the lowest slippage and were the most effective in maintaining resting pressures and amplitudes at values proven to be effective for ulcer healing.

Slippage, in cm, after 24 and 48 hours

Results from a Controlled Laboratory Study Demonstrating Slippage

Supporting Evidence: See Clinical Evidence Summaries on pages 16 and 17.

Coban 2 Layer Compression Systems had the lowest slippage.

Coban 2 Layer Lite

Coban 2 Layer

Designed for Consistent ApplicationIn practice, sub-bandage pressure is determined by the tension of the materials and the experience of the clinician. Application variability can dramatically affect the efficacy of compression: too little pressure will minimize the therapeutic benefits and too much may cause damage or may not be tolerated by the patient.

Materials Reduce Application VariabilityThe compression layer of 3M™ Coban™ 2 Layer Compression Systems was designed to be applied at full stretch to eliminate the guesswork of applying at varying extension. The materials reduce application variability to consistently deliver the appropriate pressure for therapeutic compression, regardless of clinician ability. Coban 2 Layer Compression Systems can be applied in half the time of four-layer bandage systems, and are easy to teach and easy to learn.12

Proven to be Easy to Apply ConsistentlyThe ease of use and reproducibility of applied stretch for Coban 2 Layer System was demonstrated in an international multi-center comparative evaluation against four currently marketed compression systems.12 In this study, 32 expert bandagers applied their most familiar bandage system to an artificial limb over pressure sensors three times, and then repeated the process, applying Coban 2 Layer System three times. The applied stretch was recorded for each application. The bandagers were able to apply significantly more consistent stretch with Coban 2 Layer System than with the other systems. The Coban 2 Layer System application technique was easier and faster because of the full stretch application.

Supporting Evidence: See Clinical Evidence Summary on page 17.

ProforeLayer 3

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p<0.05 p<0.05 p<0.05 p<0.05

Reproducibility of familiar bandage systems

Reproducibility of Coban 2 Layer System after a short period

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Results from an International Multi-Center Comparative Evaluation Demonstrating Reproducibility of Applied Stretch

Coban 2 Layer System provided the most consistent stretch.

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Designed for Comfort, Mobility and Daily LivingThe materials used in other multi-layer compression systems or zinc paste bandages make them bulky, cumbersome and uncomfortable, often requiring patients to wear special footwear. Painful slippage can further impede patient mobility. Simple tasks like cleaning or walking the dog can become too difficult and patients resign themselves to inactivity to relieve the pressure.

Materials Help Increase Concordance3M™ Coban™ 2 Layer Compression Systems were designed to get patients “back on their feet.” The materials used in the two-layer systems create a thin, lightweight, breathable sleeve enabling patients to wear their own shoes and clothing, so they can return to their regular daily activities. The conformable, rigid sleeve generates sustained, therapeutic working pressures and comfortable resting pressures for effective, well-tolerated compression, regardless of activity level. In randomized controlled trials,10,14 the patented two-layer systems are clinically proven to:

• Provide sustained compression without slipping

• Significantly reduce leg pain

• Reduce chronic edema

• Support healing and reduce the size of venous leg ulcers

• Improve patient comfort and physical symptoms

Studies have shown that because Coban 2 Layer Compression Systems are more comfortable, patients are more likely to keep them on, increasing concordance and improving the potential for more effective treatment.17,18

“My patients appreciate being able

to wear their own shoes.”

– Marcia Hauter, M.D., Wound Healing Center, Normal, IL

Supporting Evidence: See Clinical Evidence Summaries on pages 16, 17, 18, 19, 20, 21, 22 and 23.

Designed to Address Compression Therapy Challenges

“Standing up

all day at work

is no longer

difficult, and

I don’t come

home with sore

feet anymore.”

– Patrick Murphy, Tampa, FL

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Evidence

Evidence3M™ Coban™ 2 Layer Compression Systems are supported by a

body of evidence from clinicians worldwide, including randomized

controlled clinical trials.10,14

The following summaries demonstrate that Coban 2 Layer

Compression Systems are clinically proven to:

• provide sustained, therapeutic compression without slipping

• significantly reduce leg pain

• reduce chronic edema

• support healing and reduce the size of venous leg ulcers

• improve patient comfort and physical symptoms

• be safe and well-tolerated

• be easier to apply and remove than zinc paste bandages

• be preferred by patients

Bandage slippage for Profore and Coban 2 Layer.

Evidence

A randomised controlled 8-week crossover clinical evaluation of the 3M™ Coban™ 2 Layer Compression System versus Profore™ to evaluate the product performance in patients with venous leg ulcers.Moffatt CJ, Edwards L, Collier M, Treadwell T, Miller M, Shafer L, Sibbald RG, Brassard A, McIntosh A, Reyzelman A, Price P, Kraus SM, Walters S-A, Harding K. International Wound Journal 2008;5:267-279. Study Design: Randomized controlled trial

Key Finding: Coban 2 Layer System provided less slippage than Profore™ Compression System.

PurposeThe purpose of this study was to clinically compare two compression bandage systems for slippage, Health Related Quality of Life (HRQoL), patient preference and wound healing with venous leg ulcer patients.

Methodology• Central and local ethics approvals were obtained and written informed consent obtained.

Participants needed to be at least 18 years of age in the UK, be able to understand the questionnaire and have been treated with compression for at least two weeks prior to entry to the study, ABPI < 0.8 excluded.

• Participants were randomized to one of two bandage treatments and followed for 4 weeks. Their treatment was switched to the other compression system for a further 4 weeks and followed for a total of 8 weeks or 9 clinic visits. Participants acted as their own control.

• Primary endpoint of this study was slippage, measured from the top of the bandage to the floor post application and prior to removal. Five secondary endpoints of this study were bandage wear time, wound healing—measured by tracing, HRQoL using the Cardiff Wound Impact Schedule, patient preference and mobility using pedometer.

Results• Significantly less slippage after three to seven days with Coban 2 Layer System

(Mixed ANOVA Model from 697 measurements, p<0.0001).

• No significant differences in percent of wounds that healed (Fisher’s Exact Test, p=0.30) or in wound area reduction (Wilcoxon Rank-Sum Test, p=0.88).

• Improvements in Health Related Quality of Life (HRQoL) Physical Symptoms and Daily Living scores were significantly higher over the first 4 weeks of use for Coban 2 Layer System than Profore™ (pooled 2-sample t-test, p=0.046).

• 72% of patients preferred Coban 2 Layer Compression System over Profore™ (6% had no preference). Patient preference was similar regardless of randomization order (p>0.99).

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Summary of five case studies on the treatment of venous leg ulcers with a new two layer compression system in a community settingSylvie Hampton MA BSc (Hons) DpSN RGN, Andy Kerr RN DipHe, Mike Crossley RN RM, Tissue Viability Consultancy Services, Eastbourne, UK. Data on file at 3M. Study Design: Five-patient case study series

Key Finding: Coban 2 Layer System successfully provided effective compression therapy.

PurposeThe purpose of this study was to evaluate clinical acceptability and product performance (slippage and wear time) of 3M™ Coban™ 2 Layer Compression System.

Methodology• Five patients were followed during a six-week evaluation period.

• At each bandage application, the ankle and calf circumference of the patient was measured and recorded.

• The patient adopted a standard stance and the top of the bandage was marked at application and the height from the floor recorded. At removal, the process was repeated and any slippage recorded.

• Digital photographs recorded skin condition, wound and bandage appearance at application and removal.

• Exudate levels were assessed subjectively as “minimal,” “moderate” or “heavy.”

Results• Coban 2 Layer System was easy to learn and easy to apply.

• Coban 2 Layer system conformed well to a variety of limb shapes.

• Coban 2 Layer System was found to be aesthetically pleasing and demonstrated seven day wear time on the majority of patients (minimum wear time was four days), with minimal occurrences of strikethrough.

• Coban 2 Layer System was never changed due to slippage or sagging.

• The condition of the wound improved in all cases.

• All patients found Coban 2 Layer System comfortable and an improvement over previous compression bandage systems.

One of the patients upon initial presentation.

The same patient after three weeks. The wound had signs of granulation and epithelialization.

Evidence

Compression therapy in patients with peripheral arterial occlusive disease: A prospective clinical study with the 3M™ Coban™ 2 Layer Lite Compression System for ABPI ≥0.5Michael Jünger, PhD, MD,1 Hermann Haase PhD,1 Andrea Ladwig MD,1 Linda Schwenke,1 Jens Bichel, MD,2 Jan Schuren, RgN, BN, MSc.2 Data on file at 3M.1University of Greifswald,Fleischmannstrasse 42/43, Greifswald, Germany23M Deutschland GmbH, Neuss, Germany Study Design: Fifteen-patient, single-center, open-label study

Key Finding: Coban 2 Layer Lite System was safe for—and well tolerated by—patients with ABPIs between 0.5 and 0.8

PurposeThe purpose of this study was to assess the safety and tolerability of Coban 2 Layer Lite System in patients with an ankle brachial pressure index (ABPI) between 0.5 and 0.8, and to evaluate blood microcirculation during wear.

Methodology• A single-center, open-label study was performed on 15 patients suffering from peripheral

arterial occlusive disease with an ABPI of 0.5–0.8 (five patients with ABPI of ≥0.5 and ≤0.6, four patients with ABPI of >0.6 and ≤ 0.7 and six patients with >0.7 and ≤0.8).

• Coincident chronic venous disease was allowed but not necessary for recruitment. Six of 15 patients suffered from chronic venous insufficiency.

• All patients received treatment with the Coban 2 Layer Lite System, which stayed in place for one to four days.

• The system was reapplied by study personnel at each clinical visit (days 1, 2, 3, 4, 7, 10 and 14). Study participation stopped after 14 days. Results were summarized from 101 bandage applications.

• At each clinical visit, safety assessments were performed: Measurement of toe pulsation to detect macrocirculation, laser doppler fluxmetry at the forefoot to assess microcirculation of the dermal capillary system, clinical signs of pressure-related skin damage, substantiated by transepidermal water loss (TEWL), painful sensations as potential signs of underperfusion and subbandage pressure was measured at the B1 location. In addition, at baseline and at the end of the study limb volume was measured. A comfort questionnaire was completed at the end of the study.

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Results• Coban 2 Layer Lite System was safe for, and well tolerated by, patients with ABPIs

between 0.5 and 0.8.

• An average supine subbandage pressure of approximately 28 mmHg was measured immediately after bandage application.

• Coban 2 Layer Lite System demonstrated beneficial effects on the dermal capillary system.

• No pressure-related skin damage occurred in patients with reduced arterial perfusion.

• No pain related to tissue hypoxia was reported.

• Measurements of limbs indicated reduced volume at the end of the study compared to baseline.

• High wearing comfort, even though most patients currently were not used to wearing compression bandages.

• Results of laser doppler fluxmetry measurements indicate significant improvements of dermal microcirculation under Coban 2 Layer Lite System.

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Evidence

Evaluation of new bandage system to improve wound healing outcomes for patients with problematic venous leg ulcersGary Bain RN CNC MClinEd BN DipApSc, Director Wound Management Services, Sydney Adventist Hospital, Data on file at 3M. Study Design: Eight-patient case study series

Key Finding: 3M™ Coban™ 2 Layer Compression System obtained faster reduction in edema, pain and exudation.

PurposeThe purpose of this study was to measure wound healing outcomes for patients whose problematic venous leg ulcers had not responded to conventional compression bandaging.

MethodologyEight patients were enrolled in a four week trial of a new product evaluation. Coban 2 Layer System replaced the previously used compression bandages and patients were followed weekly for wound assessment, care and bandage application.

Results• Coban 2 Layer System obtained faster reduction in edema, pain and exudation with each

clinic assessment than traditional multi-layer compression systems previously utilized.

• Six members of the group reduced their ulcer surface area between 30–40% within the four week trial period.

• Minimal bandage bulk allowed patients to wear normal shoes.

• Pain and edema of one patient was eliminated and local erythema was reduced, seven days after initial visit.

• One patient’s ulcer was closed by the sixth weekly visit, after two years of non-healing.

• As a result, Coban 2 Layer System has been added to the clinic’s formulary therapeutic interventions.

One of the patients upon initial presentation.

The same patient after one week. Pain and edema had been eliminated and local erythema was reduced.

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Understanding the clinical and patient outcomes of new bandaging system: summary of four case studiesBill McGuiness and Jan Rice, Co-Convenors “WoW” – World of Wounds Division of Nursing and Midwifery, La Trobe University Melbourne, Victoria. Data on file at 3M. Study Design: Four-patient case study series

Key Finding: 3M™ Coban™ 2 Layer Compression System delivered comfortable resting pressures, effective working pressures and increased patient comfort.

PurposeTo gain an understanding of the effectiveness of Coban 2 Layer System in terms of clinical and patient outcomes.

MethodologyAn evaluation was conducted at two Wound Management Clinics. Four case studies were collected. Coban 2 Layer System replaced previously used bandage systems and patients were followed weekly.

Results• Coban 2 Layer Compression System was well tolerated and comfortable for all patients.

• Two patients’ persistent leg ulcers healed within the four week evaluation period.

• In all four cases, Coban 2 Layer System achieved considerable edema reduction.

• Coban 2 Layer System delivers a very effective form of compression, addressing the real challenges clinicians and patient currently face.

One of the patients upon initial presentation.

The same patient prior to the commencement of Coban 2 Layer System.

The patient’s Coban 2 Layer bandages after one week of wear.

The patient’s ulcer after two weekly applications of Coban 2 Layer System.

The patient’s ulcer healed following four weekly applications of Coban 2 Layer System.

22

Evidence

Evaluating a new and unique 2 Layer Compression System for patients with chronic venous leg ulceration Wendy Hayes, Nurse Consultant, Vascular Services, and Julie Day, Leg Ulcer Specialist Nurse, Worcestershire Acute Hospitals, NHS Trust, Abstract published in the Journal of Wound Care 2007;3M (Suppl):1–12 An Evolution in Compression. Study Design: Four-patient case series from a national study

Key Finding: 3M™ Coban™ 2 Layer Compression System provided sustained therapeutic levels of compression that patients could tolerate.

PurposeThe purpose of this study was to evaluate clinical acceptance (bandage slippage and wear time), and quality of life of venous leg ulcer patients treated with Coban 2 Layer System.

Methodology• Four patients were seen weekly in the clinic of the authors for a period of six weeks.

• At each visit their ulcers were photographed and measured.

• The bandage height from the floor to the top of the bandages was recorded on arrival before bandage change and after every application of this system to assess bandage slippage.

• The patients’ experience of the system and their comments were recorded at week three and week six.

• A lipido-colloid or other simple nonadherent wound contact layer was used beneath the compression system.

• All of the patients included in the study had previously experienced other forms of compression therapy and had not responded successfully to these treatments.

Results• Coban 2 Layer System provided sustained therapeutic levels of compression that patients

could tolerate.

• In all cases, wound dimensions reduced during the six week evaluation period.

• Coban 2 Layer System enabled patients to wear their choice of clothing/footwear and undertake their normal activities of living.

• All patients experienced an increase in comfort levels.

• All four patients were concordant with compression therapy.

One of the patients upon initial presentation.

The same patient two to three weeks later.

The same patient three to five weeks later.

23

Comparison Between a New, Two-component Compression System With Zinc Paste Bandages for Leg Ulcer Healing: A Prospective, Multicenter, Randomized, Controlled Trial Monitoring Sub-bandage Pressures Giovanni Mosti, MD; Aldo Crespi, MD, Vincenzo Mattaliano, MD. Wounds 2011;23(5):126-134. Study Design: Randomized controlled trial

Key Finding: 3M™ Coban™ 2 Layer Compression System proved to be as effective at treating venous leg ulcers as Unna Boot zinc paste bandages, while being easier to apply and remove.

PurposeThe purpose of this study was to compare the effectiveness, pain control, tolerability, exerted pressure, and ease of application and removal of Unna Boot (UB) zinc paste bandages and Coban 2 Layer System for leg ulcer healing.

Methodology• One hundred (100) patients with venous ulcers were randomized into two groups: Group A

(n=50) received UB and group B (n=50) received 3M Coban 2 Layer Compression System.

• Both bandages were applied from the base of the toes up to 3cm distal to the popliteal fossa with a pressure in the supine position of at least 40mmHg–50mmHg.

• Bandage changes were performed weekly and the objective and subjective parameters were assessed. All patients were followed weekly for three months and then monthly until complete healing was achieved.

• The primary outcomes were: ulcer healing or surface area reduction; pain; and exudate control. The secondary outcomes were: ease of application and removal of the bandage; pressure exerted in the supine and standing position after application and before removal; and bandage comfort.

Results• Coban 2 Layer System was associated with 100% ulcer healing; 94% healed within the

first three months after application of the bandage; compared with the UB, there was no statistically significant difference.

• In both groups, the effect of compression on pain and overall well-being was excellent; pain decreased by 50% within 1–2 weeks and remained low throughout the duration of treatment and overall well-being improved significantly.

• There was no significant difference between the two systems concerning level of comfort.

Kaplan Maier plot showing the ulcer healing rate in the two treatment groups. The log-rank comparison between the two curves showed no significant difference.

100

80

60

40

20

0

Perc

ent A

ctiv

e Ul

cers

Weeks

0 10 20 30

UB (n=49)

Coban 2 Layer (n=50)

Learn MoreTo learn more about 3M Coban 2 Layer Compression Therapy products, visit us at www.3M.com/coban2layer, contact your 3M representative or call the 3M Health Care Customer Helpline at 1-800-228-3957. Outside of the United States, contact the local 3M subsidiary.

References1. Moffatt, C, Kommala, D, Dourdin, N and Choe, Y. Venous leg ulcers: patient

concordance with compression therapy and its impact on healing and prevention of recurrence. Int Wound J 2009; 6: 386–393.

2. Fife C, Walker D, Thomson B, Carter M. Limitations of daily living activities in patients with venous stasis ulcers undergoing compression bandaging: problems with the concept of self-bandaging. Wounds 2007; 19: 255–57.

3. Fishman T. How to manage venous stasis ulcers. Podiatry Today 2007; 20: 66–72.

4. Brem H, Kirsner RS, Falanga V. Protocol for the successful treatment of venous ulcers. Am J Surg 2004 Jul; 188 (1A Suppl):1-8.

5. Negus D. Historical background. In: Leg Ulcers: a practical approach to management. Oxford: Butterworth-Heinemann 1991; 3-10.

6. Hargens AR, Millard RW, Pettersson K, Johansen K. Gravitational haemodynamics and oedema prevention in the giraffe. Nature 1987; 329 (6134): 59-60.

7. Pedley TJ, Haemodynamics: how giraffes prevent oedema. Nature 1987; 329 (6134): 13-14.

8. Moffatt C. Variability of pressure provided by sustained compression. Int Wound J 2008; 5 (2): 259-265.

9. Partsch H. The static stiffness index: a simple method to assess the elastic property of compression material in vivo, Dermatol Surg 2005; 31 (6): 625-630.

10. Moffatt C, Edwards L, Collier M, Treadwell T, Miller M, Shafer L, Sibbald RG, Brassard A, McIntosh A, Reyzelman A, Price P, Kraus SM, Walters SA, Harding K. A randomised controlled 8-week crossover clinical evaluation of the 3M™ Coban™ 2 Layer Compression System versus Profore™ to evaluate the product performance in patients with venous leg ulcers. Int Wound J 2008; 5 (2): 267-279.

11. Junger, M, Haase H, Ladwig A, Schwenke L, Bichel J, Schuren J. Compression therapy in patients with peripheral arterial occlusive disease: A prospective clinical study with the 3M™ Coban™ 2 Layer Lite Compression System for ABPI ≥ 0.5. Data on file at 3M. 2010.

12. Collier M, Schuren J. Ease of use and reproducibility of five compression systems. J Wound Care 2007; 3M Supplement: 8-10.

13. Hampton S, Kerr A, Crossley M. Summary of five case studies on the treatment of venous leg ulcers with a new two layer compression system in a community setting. Data on file at 3M. 2006.

14. Mosti G, Crespi A, Mattaliano V. Comparison Between a New, Two-component Compression System With Zinc Paste Bandages for Leg Ulcer Healing: A Prospective, Multicenter, Randomized, Controlled Trial Monitoring Sub-bandage Pressures. Wounds 2011; 23 (5): 126-134.

15. Schuren J, Mohr K. The efficacy of Laplace’s equation in calculating bandage pressure in venous leg ulcers. Wounds UK 2008; 4 (2): 38-47.

16. Schuren J, Mohr K. Pascal’s law and the dynamics of compression therapy: a study on healthy volunteers. Int Angiol 2010; 29 (5): 431-5.

17. Schuren J, Andreas C. Pressure and slippage during 48 hours of compression therapy: a study on healthy volunteers. Poster presentation: SAWC 2010.

18. Schnobrich E, Solfest S, Bernatchez S, Zehrer C, Tucker J, Walters SA. 7-Day, In-use Assessment of a Unique, Innovative Compression System. Data on file at 3M. Poster

presentation: SAWC 2006.

Ordering Information: 3M Coban 2 Layer Compression Therapy

Product Name3M™ Coban™ 2 Layer Compression System for patients with ABPI ≥ 0.8

3M™ Coban™ 2 Layer Lite Compression System for patients with ABPI ≥ 0.5

Catalog No. 2094 2794

Roll 1Comfort Layer

HCPCS Code: A64414 in x 2.9 yd (10 cm x 2,7 m) Unstretched

HCPCS Code: A64544 in x 2.9 yd (10 cm x 2,7 m) Unstretched

Roll 2Compression Layer

HCPCS Code: A64524 in x 5.1 yd (10 cm x 4,7 m) Stretched4 in x 3.8 yd (10 cm x 3,5 m) Unstretched

HCPCS Code: A64544 in x 5.1 yd (10 cm x 4,7 m) Stretched4 in x 3.5 yd (10 cm x 3,2 m) Unstretched

Rolls/Box 2 rolls, 1 of each layer 2 rolls, 1 of each layer

Boxes/Case 8 8

The American Medical Association (AMA) has established a CPT code for the application of multi layer compression systems - CPT Code 29581. Physicians and other healthcare providers treating patients with multi layer compression therapy may be eligible for reimbursement for their services.

Current Procedural Terminology (CPT) is a listing of descriptive terms and identifying codes for reporting medical services and procedures physicians and other medical professionals perform.

HCPCS and CPT codes have been provided to assist you in the preparation of insurance claims. Please note, however, that the reimbursement information provided by 3M Health Care and its representatives is intended to provide general information relevant to coverage and coding for 3M products. Insurers’ reimbursement policies can vary and the use of the codes discussed here does not guarantee that an insurer will cover or pay at any particular level. Health care providers should exercise independent clinical judgment in choosing the codes which most accurately describe the products provided.

3M™ Coban™ 2 Layer Compression Therapy is supported by a variety of clinical data and publications in wound care. In this brochure you will find a selection of clinical studies, case studies and other publications that include 3M™ Coban™ 2 Layer Compression System and 3M™ Coban™ 2 Layer Lite Compression System. The Key Messaging featured in each summary was developed to help summarize the publication in a brief and easy-to-use format. If you have questions or need a copy of the complete, published article, abstract, or case study, contact your 3M Health Care Sales Representative or call the 3M Health Care Customer Helpline at 1-800-228-3957.

Actico is a trademark of Activa Healthcare, Ltd. Profore and Proguide are trademarks of Smith & Nephew. KTwo is a trademark of Laboratoires URGO. Rosidal is a trademark of Lohmann & Rauscher GmbH & Co. KG. 3M and Coban are trademarks of 3M. Please recycle. Printed in U.S.A. © 3M 2010, 2014. All rights reserved. 70-2010-7269-4

Critical & Chronic Care Solutions Division3M Health Care2510 Conway Ave.St. Paul, MN 55144USA1-800-228-3957www.3M.com/coban2layer