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An innovative compression system providing low, sustained resting pressure and high, efficient working pressure

Authors:
Josefin Damm at PressCise
Josefin Damm
  • PressCise
Torbjörn Lundh at Chalmers University of Technology
Torbjörn Lundh
Hugo Partsch at Medical University of Vienna
Hugo Partsch
Giovanni Mosti at MD Barbantini Hospital
Giovanni Mosti
  • MD Barbantini Hospital
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Veins and Lymphatics 2017; volume 6:6627
[page 12] [Veins and Lymphatics 2017; 6:6627]
An innovative compression
system providing low,
sustained resting pressure and
high, efficient working pressure
Josefin Damm,1Torbjörn Lundh,2
Hugo Partsch,3Giovanni Mosti4
1PressCise AB, Herrljunga, Sweden;
2Chalmers University of Technology,
Gothenburg, Sweden; 3Medical
University of Vienna, Austria;
4Angiology Department, Clinica MD
Barbantini, Lucca, Italy
Introduction
Chronic venous insufficiency (CVI) can
cause considerable morbidity and reduced
quality of life.1 Compression therapy, such
as bandages and stockings, is the corner-
stone and golden standard in the prevention
and treatment of CVI today.2 It is also
shown that compression used after the heal-
ing of ulcers, reduces the rate of
recurrence.3 It has been found that compres-
sion products with a stiff, non-elastic mate-
rial, are essential for an improved haemody-
namic effect, indicating that low resting
pressure and high working pressure is vital,
in order to achieve the most effective and
well tolerated compression treatment.4
However, one great challenge is that by
applying a stiff bandage, either as a single
component or as a part in a multi-compo-
nent product, one always adds, a not so eas-
ily quantified, resting pressure. In order to
achieve the most effective treatment it is
easy to apply the bandage in a too tight and
uneven manner, often resulting in painful
resting pressures.4 In earlier studies, it has
been shown that common for todays prac-
tice is that the compression treatment is
dependent on the applier and that only
about 10% of the healthcare personnel man-
agers to apply a pre-defined target bandage
pressure.5 It has also been shown that the
applied pressures decrease in effectiveness,
only after a couple of hours, due to e.g.
oedema reduction, resulting in poor com-
pression treatment over time.6
Aim
The goal is to find a method to provide
a well-defined resting pressure and a
method that increases the working pressure
without changing the pre-defined resting
pressure, as well as maintaining the pres-
sure over time.
Materials and Methods
First, an elastic compression bandage
(Lundatex® medical by PressCise) provid-
ing and maintaining a certain pressure level
was applied on the leg. The bandage is
based on Laplace’s law, where the pressure
is a product of the force, times the overlap,
times the curvature. The bandage is provid-
ed with visual guidelines for correct stretch
per each turn and correct overlap. Due to
the specific elastic properties in the material
the force is adjusted to the changes in cur-
vature when the guidelines are followed.
This results in a well-defined pressure, with
minimal variability. Several patches
(PressPatch™ by PressCise AB) made in a
hook and loop material and with an optimal
shape, were attached over the elastic band-
age, creating a multicomponent compres-
sion system (Lundatex® system by
PressCise AB). The patches adhere directly
to the bandage material without any force
being added; hence there is no increase of
resting pressure. In the front of the leg a
special patch was added (FixPatch™ by
PressCise AB). This patch can be opened
easily e.g. every morning, in order to main-
tain the pressure level over time. In one
pilot-study interface pressures were meas-
ured on point B1 and C on patients with
severe venous reflux in the great saphenous
vein (CEAP C2-C5), during lying and
standing (n=18). Three consecutive meas-
urements where done: 1) the elastic band-
age applied to the leg with a pressure of 20
mmHg, 2) the elastic bandage applied to the
leg with a pressure of 30 mmHg and 3) after
attaching the stiff patches to the elastic
bandage. In a second pilot-study the pres-
sure was measured on one health volunteer
at B1, over seven days. Measurements were
taken in supine, at dorsal flex and standing
position, twice a day. The pressure-measur-
ing device used was PicoPress® (by
Microlab Italia).
Results
The elasitc bandage provides a well-
defined pressure, independent of placement or
position. The patches add the stiffness to the
underlying material and increase only the
working pressure. With the patches, resting
pressure is close to the same pressue as before,
however working pressure increases signifi-
cantly. As expected, there were a significant
drop of working pressure in the evening day
one in the 2nd pilot-study, due to some odema
reduction. The correction of the FixPatch™
Correspondence: Josefin Damm, PressCise
AB, Herrljunga, Sweden.
E-mail: josefin@presscise.com
Conflict of interest: two of the authors have
commercial interest to declare. Josefin Damm
and Torbjörn Lundh are co-inventors of the
patches. The authors are also co-founders of
the start-up company PressCise AB.
This work is licensed under a Creative
Commons Attribution 4.0 License (by-nc 4.0).
©Copyright J. Dammet al., 2017
Licensee PAGEPress, Italy
Veins and Lymphatics 2017; 6:6627
doi:10.4081/vl.2017.6627
Figure 1. Pressure measurements on B1, in supine (resting) and standing position with
the bandage providing 20 mmHg and 30 mmHg (baseline) and pressure measurements
in supine and standing position with the patches added over the bandage (patches).
(n=18).
Conference presentation
[Veins and Lymphatics 2017; 6:6627] [page 13]
each morning, however, maintained the work-
ing pressure level over seven days.
Conclusions
The presented device is of considerable
practical interest in order to achieve a quan-
tified compression treatment. It may also be
especially essential for those patients who
should have a low controlled resting pres-
sure, as e.g. patients with mixed arterial
venous disease and for whom hemodynam-
ically active pressures are desirable as soon
the patient is active. The easy way to main-
tain the pessure level over time may also be
of great benefit for self-management.
References
1. Moffatt CJ, Franks PJ, Doherty DC, et
al. Psychological factors in leg ulcera-
tion: a case-control study. Br J Dermatol
2009;161:750-6.
2. Partsch H. Understanding the patho-
physiology of compression.
Understanding compression therapy:
EWMA position document; 2003.
3. O’Meara S, Cullum N, Nelson EA,
Dumville JC. Compression for venous
leg ulcers. Cochrane Database Syst Rev
2012;11:CD000265.
4. Partsch H, Clark M, Bassez S, et al.
Measurement of lower leg compression
in vivo: recommendations for the per-
formance of measurements of interface
pressure and stiffness. Dermatol Surg
2006;32:224-33.
5. Protz K, Heyer K, Dörler M, et al.
Compression therapy: scientific back-
ground and practical applications. J
Dtsch Dermatol Ges 2014;12:794-801.
6. Protz K, Heyer K, Verheyen-Cronau I,
Augustin M. Loss of interface pressure
in various compression bandage sys-
tems over seven days. Dermatology
2014.
Figure 2. Pressure measurement over seven days, on one subject. Correction of the front
patch (FixPatch™) was done daily, before bed rise
... Whereas patients can apply LSBs independently, with SSBs, the help of a trained healthcare professional or a family member is required [20]. Unfortunately, only 10% achieve the target interface pressure [19,22]. The most common error is overly loose application, typically seen with SSBs, which -even with full initial stretch -tend to lose their haemodynamic efficacy within the first hours following application, as a result of leg oedema reduction [3,23]. ...
... In order to maintain the target interface pressure, new technological solutions are introduced, such as compression bandages with printed shapes (ovals or rectangles) which turn into circles or squares once target pressure is applied, or those with line indicator systems (longitudinal or transverse) which ensure sustained pressure and equal layer overlaps. Thus, smart bandages are used, into which silver strain gauge transducers are knitted, which enable real time measurement of interface pressure [18,22,25]. Even though, their application varies and the interface pressure values can only be approximated. ...
... of oedema of healthy individuals with job-related risk factors (prolonged standing or sitting position) and in wheelchair users (Grade 1B)[3] • Improvement of clinical symptoms of CVD (C0s-C1s, e.g. leg heaviness) of pregnant women with varicose veins (Grade 1B)[3] • Prevention of thromboembolic complications of patients after surgery (ensuring proper hydration and, if high-risk, also anticoagulant treatment) (Grade 2C)[3] • Thrombosis prevention if anticoagulant treatment is contraindicated (Grade 2B)[3] • Keeping the dressing in place in VLU (external ulcer kit layer)[20][21][22][23][24][25][26][27][28][29][30] • Oedema reduction in patients with CVD and job-associated leg oedema (Grade 1B)[3] • Improvement of clinical symptoms and quality of life of patients with CVD and pregnant women with varicose veins (Grade 1B)[3] • In the management of small telangiectases after sclerotherapy in order to achieve better treatment outcomes and reduce postoperative complications (pain, oedema, bruising, discoloration) (Grade 2B)[3] • Prevention of deep vein thrombosis (DVT) in high-risk groups and long-distance travellers (if very high risk, MCS and anticoagulant treatment should be used together) (Grade 2B)[3] • Treatment of acute DVT (to avoid thrombus propagation, reduce severity of clinical symptoms, such as pain and oedema, as well as accelerate patient ambulation, directly after diagnosis) (Grade 1B)[3] • Prevention of post-thrombotic syndrome (PTS) (Grade 1B)[3] • Treatment of patients with PTS (Grade 1B)[3] ...
Compression therapy in venous diseases: current forms of compression materials and techniques
Article
Full-text available
  • Jul 2019
  • Adv Dermatol
Compression therapy (CT) is an established treatment method in chronic venous disease (CVD). The paper presents information on different CT forms with indications and contraindications based on expert consensuses from recent years. A high prevalence of CVD implies continuous development of compression materials, systems and techniques as well as measurement methods. The article aims at reviewing available literature on the development of compression therapy techniques.
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... The same smart textile technology used in the sock has previously been evaluated in a knee-high stocking. 10 An elastic bandage (Lundatex® medical, PressCise, Sweden) with built-in welldefined and controlled pressure [11][12][13] was wrapped along the leg, starting on the cuff of the sock. By this application approximately 5 cm of bandage covered the cuff ( Figure 1B). ...
... [6][7][8][9]16,17 The results in the present study confirm previous studies on this special bandage. [11][12][13] Interface pressures on the foot and ankle areas were fairly consistent between subjects despite the same sock sample was used on all subjects. This indicates that correct compression is ensured without a need for custom-fitting of the sock. ...
... This fusion method will not be possible with traditional bandages; it requires a bandage with built-in pressure control [11][12][13] and a sock with assured pressure regardless of foot/ankle size. ...
Good-bye slippage - a new fusion to tackle bandage slippage on the foot
Article
Full-text available
  • Dec 2018
A common problem related to compression treatment with bandages is slippage at and around the foot and heel. Stiff bandages in particular tend to cause slippage due to reduction in limb size during compression treatment, and the inherent inability of the material to recover post-stretch. The use of stockings can often reduce this risk of slippage. However, stockings can be tricky to don, especially when ulcers are involved. An optimal solution for indica- tions that are best treated with bandages on lower extremities seems to be a compres- sion sock on the foot and a bandage on the leg. The aim was to find a compression sock-bandage fusion method that provides well-defined pressure on the foot, around the ankle and along the leg. Thirteen healthy subjects were enrolled. Three pressure sensors were placed uni- laterally on all subjects (A) on the foot, (B) at the ankle and (C) on the calf. A short ankle sock was applied on the foot, ending just above the malleoli. The sock is designed to provide a pressure of 20 mmHg except for the cuff that is designed to apply only 10 mmHg. An elastic bandage with built-in well-defined and controlled pressure was wrapped along the leg, starting on the cuff of the sock. By this application approximately 5 cm of bandage covered the cuff. The bandage is designed to provide 20 mmHg of pressure along the leg, with a 50% overlap (i.e., each bandage layer provides 10 mmHg of pressure). The sock-bandage fusion method applied a well-defined pressure at the foot, ankle and leg. No significant differences in interface pressures were found between locations A, B or C in supine (P>0.7) or in standing (P>0.11) positions. The proposed fusion solu- tion may not only prevent bandage slippage on the foot, but it may help patients pre- serve their full ankle range of motion and allow them to wear normal footwear.
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... To a lesser extent, it also depends on elastic properties of the bandage and the number of layers. Furthermore, as the leg circumference decreases, it is more difficult to maintain constant interface pressure, which is why it (and, as a result, the effective compression dose, as well) cannot be precisely determined in most cases [14,[26][27][28]. On the other hand, the intermittent pneumatic compression (IPC) devices offer predefined compression and interface pressure. ...
... It consists of two components, the Lundatex ® medical bandage, which provides a safe and well-defined resting pressure owing to a cross-line indicator system, and two velcro products called PressPatch™ and FixPatch™. Adding stiff velcro products not only turns an elastic bandage into an inelastic compression device, but also enables hassle-free maintenance of target interface pressure by readjusting the FixPatch, without the need to re-bandage [19,26]. ...
Compression therapy in venous diseases: physical assumptions and clinical effects
Article
Full-text available
  • Jul 2019
Compression therapy (CT) is an established treatment method in chronic venous disease. Despite years of clinical experience, choosing the optimum compression therapy, including grade and pressure distribution, which determine the efficacy of treatment poses a challenge. The paper discusses CT physical assumptions (stiffness, elasticity, static and dynamic stiffness indices), clinical effects and contraindications to CT.
View
... To a lesser extent, it also depends on elastic properties of the bandage and the number of layers. Furthermore, as the leg circumference decreases, it is more difficult to maintain constant interface pressure, which is why it (and, as a result, the effective compression dose, as well) cannot be precisely determined in most cases [14,[26][27][28]. On the other hand, the intermittent pneumatic compression (IPC) devices offer predefined compression and interface pressure. ...
... It consists of two components, the Lundatex ® medical bandage, which provides a safe and well-defined resting pressure owing to a cross-line indicator system, and two velcro products called PressPatch™ and FixPatch™. Adding stiff velcro products not only turns an elastic bandage into an inelastic compression device, but also enables hassle-free maintenance of target interface pressure by readjusting the FixPatch, without the need to re-bandage [19,26]. ...
Compression therapy in venous diseases: physical assumptions and clinical effects
Article
Full-text available
  • Jul 2019
  • Adv Dermatol
Compression therapy (CT) is an established treatment method in chronic venous disease. Despite years of clinical experience, choosing the optimum compression therapy, including grade and pressure distribution, which determine the efficacy of treatment poses a challenge. The paper discusses CT physical assumptions (stiffness, elasticity, static and dynamic stiffness indices), clinical effects and contraindications to CT.
View
... This means that the system can easily be self maintained, by the patient himself or by a relative for 7 days, with sustained resting and working pressure. 11 The bandage is a single use product, but all patches are washable and reusable. The price of the complete system is higher than other systems. ...
... In contrast to this, the new system keeps the CP constant for several days. 11 Different experimental studies in the past have demonstrated that a pressure of around 60 mmHg in the upright position together with the massaging effect at calf level reduce venous reflux 19,20 and ambulatory venous hypertension, 21 thereby enhancing the efficacy of the venous calf pump. 8,9 Bandages applied with higher pressure over the calf could also be shown to reveal stronger beneficial effects on the calf muscle pump. ...
A New Two Component Compression System Turning an Elastic Bandage into an Inelastic Compression Device: Interface Pressure, Stiffness, and Haemodynamic Effectiveness
Article
  • Nov 2017
  • EUR J VASC ENDOVASC
Introduction: Bandage application does not exert consistent compression pressure, leading to extremely variable compression when applied to patients. A new elastic bandage can exert a predefined pressure independently of healthcare providers and the size of the wrapped limb. The bandage system includes a series of non-stretchable patches that when applied to the bandage make it stiff. The aim of this work was to assess, in an experimental setting, the venous ejection fraction (EF) from the lower leg and the tolerability of this new bandage in a group of patients affected by superficial venous incompetence. Methods: EF was measured using strain gauge plethysmography under baseline conditions and the bandage was applied with a supine pressure of 20 and 30 mmHg, with and without the stiff patches, in 25 patients with severe venous reflux in the great saphenous vein. The interface pressure of the bandages was measured simultaneously in the medial gaiter area. Results: All patients showed EF values that were significantly reduced compared with normal individuals. Elastic bandages with an average pressure of 20 and 30 mmHg in the supine position achieved a slight improvement in EF, and, after applying non-stretchable patches on the same bandage with similar resting pressure, EF was restored to its normal range (p < .001). Improvement in EF correlates with the pressure differences between standing and lying pressure and between muscle systole and diastole during exercise. Conclusion: This study confirms that inelastic is much more effective than elastic compression for improving impaired venous haemodynamics. The test material can be applied with a predetermined pressure, which considerably enhances the consistency of application, and it is easily transformed into an inelastic system just by applying stiff patches without any stretch and without significantly increasing the comfortable supine pressure.
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Fibers for Medical Compression
Article
  • Apr 2020
This chapter reviews several aspects of fibers used in compression therapy. Compression therapy is recommended for the treatment and prevention of the chronic venous disorders primarily found in the lower extremities. The success of medical compression depends on the pressure that is influenced by a number of complex factors – material and structure characteristics, the limb geometry, the application technique, and the physical activity taken by the patient. Understanding the exact formulation and performance of different fibers and structures would be extremely helpful to design optimized product delivering maximum clinical benefits to a patient. This chapter reviews different textile fibers and structures used in medical compression. A multidisciplinary approach is followed to include various concepts of physics, biological science, biomaterials, fabric engineering, structural dynamics, material science, etc. to better deal the subject from different perspectives. Some innovative fibers, like memory fiber, are also introduced to show their future potential in this area.
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Loss of Interface Pressure in Various Compression Bandage Systems over Seven Days
Article
  • Nov 2014
  • DERMATOLOGY
Background: Manufacturers' instructions of multi-component compression bandage systems inform that these products can remain up to 7 days during the therapy of venous leg ulcer. This implies that the pressure needed will be sustained during this time. Objective: The present research investigated the persistence of pressure of compression systems over 7 days. Methods: All 6 compression systems available in Germany at the time of the trial were tested on 35 volunteering persons without signs of venous leg disease. Bandaging with short-stretch bandages was included for comparison. Pressure was measured by using PicoPress®. Results: Initially, all products showed sufficient resting pressure of 40 mm Hg checked with a pressure monitor, except for one system in which the pressure fell by at least 23.8%, the maximum being 47.5% over a period of 7 days. Conclusion: The currently available compression systems are not fit to keep the required pressure. Optimized products need to be developed.
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Compression therapy: Scientific background and practical applications
Article
  • Aug 2014
  • J DTSCH DERMATOL GES
Background Compression bandaging is the most prevalent form of treatment for venous leg ulcers. Successful treatment requires knowledge of the appropriate materials and the ability to employ them following current guidelines. This study investigates German health-care providers for their knowledge of bandage materials and their practical ability in applying short-stretch compression bandages.Participants and Methods Within the framework of nationwide practical education on compression therapy, the participants’ knowledge was quantified by asking standardized questions. Furthermore, their practical ability was evaluated by having them apply compression bandages within a pressure range of 50–60 mmHg. Another criterion was the pressure drop after a four-time dorsiflexion.ResultsOverall, 891 providers (3.3 % physicians, 5.5 % medical assistants, 90.7 % nursing staff) participated. Within the practical test only few (just under 10%) applied the bandages with the intended pressure; 77.0 % applied them below and 13.7 % above the target pressure. After a four-time dorsiflexion there was an average pressure drop of 6.7 mmHg. Surveying the participant's skills revealed that only 11.9 % knew about padding beneath compression bandages, 15.0 % knew of multi-component systems, and 14.8 % were familiar with ulcer stocking systems.Conclusions Clearly, compression material and its application are unfamiliar to most practice employees. Without question there are deficits in the provision of compression therapy.
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Psychological factors in leg ulceration: A case-control study
Article
  • Jul 2009
  • BRIT J DERMATOL
There is increasing recognition of the role that psychological status plays in the development and outcomes of chronic disease, but little understanding of its importance in chronic leg ulceration. To examine psychological health and perceived social support in patients with chronic leg ulceration. Patients with leg ulceration within a defined population were matched for age and gender (1:1) with community controls in a matched case-control study. Analysis was by conditional logistic regression and matched t-test analysis. Ninety-five patients (60 women and 35 men; 59% aged over 75 years) were identified and matched to the same number of controls. Cases had significantly poorer health-related quality of life in all domains of the Nottingham Health Profile (all P < or = 0.001), compared with controls. Levels of depression (Hospital Anxiety and Depression Scale) were significantly greater in the patient group (mean 5.3 vs. 3.6, P < 0.001). Social support (Medical Outcomes Study Social Support Survey scale) showed significantly fewer social networks and less perceived social support in patients than controls (P = 0.008). Patients used significantly fewer coping strategies (COPE scale) than controls, particularly with regard to problem-focused coping strategies. Patients with leg ulceration experience poor psychological health with a greater risk of depression, less perceived social support and greater social isolation. Systems of care should offer an environment that reduces social isolation and increases support to this patient group.
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Compression Bandaging for Venous Leg Ulcers
Article
  • May 1997
  • Prof Nurse
Effective compression heals leg ulcers and prevents their recurrence. Incorrect bandaging and poor technique are often features of leg ulcer management. A number of bandage systems are currently in use. Multi-layer systems appear to be more effective than single-layer systems.
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Measurement of Lower Leg Compression In Vivo: Recommendations for the Performance of Measurements of Interface Pressure and Stiffness
Article
  • Mar 2006
Interface pressure and stiffness characterizing the elastic properties of the material are the parameters determining the dosage of compression treatment and should therefore be measured in future clinical trials. To provide some recommendations regarding the use of suitable methods for this indication. This article was formulated based on the results of an international consensus meeting between a group of medical experts and representatives from the industry held in January 2005 in Vienna, Austria. Proposals are made concerning methods for measuring the interface pressure and for assessing the stiffness of a compression device in an individual patient. In vivo measurement of interface pressure is encouraged when clinical and experimental outcomes of compression treatment are to be evaluated.
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Understanding compression therapy: EWMA position document
  • Jan 2003
  • H Partsch
Partsch H. Understanding the pathophysiology of compression. Understanding compression therapy: EWMA position document; 2003.