Our research and development teams operate at a global level and generate synergies from our collective expertise and by drawing on related disciplines. We are also constantly exchanging information at an international level with independent technical institutions, key opinion leaders and multipliers in order to be able to ensure cooperation and knowledge management of the highest order. As part of this process, we also conduct extensive research, the results of which we continually present in workshops, at conferences and symposiums - either in documentation or talks given by our cooperation partners - and also publish in renowned scientific journals. This database contains a large number of these evidence-based scientific articles, most of which have been evaluated by independent assessors:
Tissue fibrosis is improved with addition of textured compression garment to patients’ chronic oedema management programPoster presented at ALA Virtual Conference 2020 28.05.2020 Hobart, Australia
Chronic edema is associated with significant trophic changes including not only increased volume but also trophic changes.1-3 Compression has been shown to have a positive impact on trophic changes including reduced tissue fibrosis.1-4 It has been observed that textured compression, utilizing chipped foam or channeled foam, has a significant improvement on tissue fibrosis.5 Aim of this study was to objectively measure the change in tissue fibrosis following the use of a textured compression product.
Observational study tracking outcomes of four patients (n=4) utilizing a textured compression garment at night. Garments were chosen as best fit for patient by therapist and were not the same across the subjects. Measurements included: volume of the limb, tissue density, and subject self-reported quality of life. Measurements were taken at three different intervals over a two month period. Tissue fibrosis was taken as a tissue density measurement using a tissue tonometer.6-8 The Lymphedema Quality of Life (LYM-QOL) questionnaire was used to capture patient’s self-reported improvement in quality of life. 9
In all subjects, both volume and tissue fibrosis were reduced. Two out of four subjects were recorded with at least a 5% reduction in volume and three out of four subjects recorded a 5% or greater tissue density improvement.
This study was limited by several variables. Such as, garments were chosen as best fit for patient by therapist and were not from same manufacturer or style across the subjects. Generally, these patients had previous lymphedema treatment and had nearly stable volumes, but significant fibrosis limiting their concordance with regimen. There are other tools, such as, an indurometer, which may allow more accurate measurement of fibrosis.
The use of textured compression garments as part of a night time regimen reduced tissue fibrosis for patients with chronic edema. Patients in this study demonstrated improved concordance as evidenced by stable volume and reports of compliance, with improved quality of life in all subjects. Additional study is warranted to assess further impact on overall compliance and concordance in garment regimen with reduction in fibrosis of the limb.Further versions
Providing Compression Options: The Key to Better Compliance and ConcordancePoster presented at ALA Virtual Conference 2020 28.05.2020 Hobart, Australia
Compression remains the gold standard for long-term management of chronic edema. Reviews have shown that the benefits of compression diminish according to levels of non-adherence. Reasons commonly stated for nonadherence to compression include inconvenience, heat, cost, and pain. We hypothesize that offering compression options will have positive impact on patients’ compliance and concordance to compression regimens.
Observational study performed at 2 different edema management clinics. Ten patients presenting with lower extremity swelling and history of non-compliance with previous compression regiments were observed. Objective data measured included limb volume, range of motion (ROM), functional activity status using the Timed Up and Go(TUG), and assessment of quality of life (QOL) using the Lymphoedema QOL Tool (LYMQOL-LEG). Measurements were taken at four different intervals over a minimum of 3 months. Compression options were individualized to patient's physical presentation and lifestyle for long term management of their edema.
Results / Discussion:
Compression therapy had a positive impact on all outcomes measured during the intensive phase of therapy. Follow-up outside the intensive phase of therapy demonstrated further volume loss in 6/10 subjects; Volume remained constant 3/10, increased slightly 1/10. LYMQOL scores and functional performance level maintained stable during the follow-up period.
Offering multiple compression options including custom and ready-to-wear flat knit stockings*, an adjustable wrap ** and nighttime compression options*** had a positive impact on patients’ adherence to compression regimens during the study period compared to single compression modalities offered previously. Individualizing the compression regimen to each patient’s lifestyle improved their adherence to chronic edema management.Products Rosidal TCSFurther versions
The use of night time garments for chronic oedema management impacts patients’ quality of life and oedema managementPoster presented at ALA Virtual Conference 2020 28.05.2020 Hobart, Australia
Successful management of chronic edema requires a commitment to compression bandaging, garments and/or use of alternative bandage wraps.1-2 Some patients require continuous compression day and night.1,3 The aim of this investigation was to assess the impact on volume control and patients’ quality of life (QOL) with the addition of a nighttime garment to their compression regiment.
This observational study details four patients (n=4) medical history, subjective reports and objective measurements of limb volume and self-reported QOL before, during and after the addition of a nighttime garment to their compression regiment. Circumferential measurements were taken to track limb volume and The Lymphedema Quality of Life (LYM-QOL)4 questionnaire was used to capture patient’s self-reported improvement in quality of life. The assessment period was over a minimum of 6 weeks. Measurements were taken at three different intervals.
It was observed that all subjects had an improvement in their self-reported quality of life (via LYM-QOL). Limb volume was stable in two out of four patients. Two out of four demonstrated further volume loss with the addition of nighttime product.
The addition of a nighttime compression device demonstrated positive change in self-reported QOL as well as better overall edema management. Patients who previously had struggled with long term edema management demonstrated improved edema control. Additional investigation is warranted to study impact of inclusion of a night time garment as part of the standard of care for those patients living with chronic edema.Further versions
Establishment of a moist environment by a new foam dressing* beneficial for wound healing in vitroPoster presented at CICA 2020 26.01.2020 Paris, France
Modern wound dressings are expected to maintain a humid wound milieu, which is thought to aid cell proliferation and migration resulting in faster and better wound healing. Foam dressings are thought to aid in the establishment of a beneficial moist wound environment as they exhibit excellent fluid management capacity by absorbing as well as donating fluid. Therefore, a scratch wound healing model using human fibroblasts and keratinocytes was developed depending on the donation of fluid by the applied dressings. The effect on cell proliferation and migration necessary for wound healing and epithelization was investigated for the new foam dressing (NFD)* and compared to cotton gauze as standard of care dressing (SOCD)**.
Material & Methods
Human dermal fibroblasts (DF) and human epidermal keratinocytes (HaCaT) were seeded into 6-well-plates and cultivated for 48h until confluence before scratching. Cell scratches cultivated in medium served as positive controls for optimal wound healing (figure 1). Samples of NFD (*Suprasorb® P sensitive, Lohmann&Rauscher) and SOCD (**cotton gauze, Fuhrmann) were cut aseptically (d = 3.5 cm), soaked in medium and applied directly on the cell scratches without further addition of medium supply. Cells were stained with hematoxylin/eosin after 1, 6, 24, and 48 hours. Scratches were photographed using a digital microscope (Keyence) and the scratch area was evaluated using the Image J program.
Scratches covered with SOCD cotton gauze exhibited no tendency for healing (figures 2 and 3), which could be attributed to a distinct parching of the cells under the conditions of the scratch wound assay+. Accordingly, cells featured a roundish phenotype and cell confluence was partly lost with the scratches remaining open at the end of the experiment. In contrast, NFD supported the scratch healing in vitro by promoting keratinocyte (figure 2) and fibroblast (figure 3) proliferation and migration through establishing a moist wound environment. A slight tendency of the cells to adhere to the foam dressing, which provides a 3D matrix for the cells, could be observed featuring a possible explanation why scratch healing under the dressing samples was slower compared to the medium control.
A scratch wound healing model using human fibroblasts and keratinocytes depending on the donation of fluid by the applied dressings could be successfully developed. It can be used to assess the capacity of wound dressings for establishing a moist wound environment that is thought beneficial for healing. Here, it could be shown that the NFD is able to promote wound healing in vitro by effectively creating humid conditions favouring wound closure while the SOCD was not able to maintain the moist environment resulting in nonhealing cell scratch wounds in vitro.Products Suprasorb P sensitiveFurther languages
In-vivo-Druckmessungen zum Vergleich medizinischer adaptiver Kompressionssysteme mit maßangefertigter Flachstrick-KompressionsversorgungPhlebologie 2020
Die in der Erhaltungsphase der komplexen physikalischen Entstauungstherapie notwendige Kompressionstherapie kann anstelle von Flachstrick-Kompressionsstrümpfen (FS) auch mit vom Patienten selbst anzulegenden Bandagen erfolgen, den sogenannten medizinischen adaptiven Kompressionssystemen (MAK).
MAK und FS wurden mittels In-vivo-Druckmessungen unter der von Probanden selbst angelegten Kompression direkt verglichen. Dazu wurden Drücke über Picopress®-Messgeräte und Sensoren (Microlab Elettronica, Italien) an n = 30 Patienten mit beidseitigen, symmetrischen, lymphostatischen Ödemen der Unterschenkel erfasst. FS und MAK wurden seitenrandomisiert zugewiesen. Nach Standardeinweisung und initialen Druckmessungen beider Systeme wurden MAK im Zeitverlauf von 2 und 4 h Tragedauer erneut gemessen. Static-Stiffness-Index (SSI) sowie Druckgradienten der Messhöhen B1-C wurden berechnet.
MAK zeigen Ruhedruckwerte und SSI im therapeutischen Bereich, die signifikant höher ausfallen als bei FS (p < 0,01 bzw. p < 0,001). MAK erreichen signifikant höhere maximale Arbeitsdrücke (p < 0,001). Die Ruhedruckwerte von MAK zeigen nach 2 und 4 h, ohne Nachjustieren, keinen relevanten Druckabfall. Die mittleren Druckgradienten, bezogen auf die Messhöhen B1-C, unterscheiden sich nicht signifikant zwischen den Methoden.
Die mit MAK erreichten Druckparameter untermauern deren therapeutische Effektivität. Die Anwendung von MAK ist auch ohne Nachjustieren druckstabil. Die Anwendung (Selbstanlage) kann als therapeutisch wirksam eingestuft werden. Eine gute Einweisung der Patienten ist jedoch bedeutsam.
Spezifischer biphasischer Druckaufbau unter nicht nachgiebigen Kompressionsverbänden beim intensiven GehenVasomed 2020 32(2) 5460
110 Jahre nach Heinrich Fischers Veröffentlichung “Eine neue Therapie der Phlebitis” (7) möchten wir Daten aus unseren mobilen Grenzflächen-Druckmessungen unter nicht nachgiebigen Fischer-Verbänden veröffentlichen. Wir zeigen die biologisch physikalischen Gesetzmäßigkeiten auf, die über das Phänomen des biphasischen Druckaufbaus für die deutlich höheren Arbeitsdruckwerte unter nicht nachgiebigen Materialien im Vergleich zu nachgiebigen Kompressionsmedien beim schnellen und ausgedehnten Gehen verantwortlich sind.
Wir verwendeten das von der Universitäts-Hautklinik Tübingen in Zusammenarbeit mit dem MIPM 1996 entwickelte Kompressionsdruck-Messsystem MCDI-1 (20) in der Spezialversion PIVI. Es arbeitet mit einem piezoresistiven Sensor. Darüber modellierten wir einen fixierten nicht nachgiebigen Unterschenkelkompressionsverband nach Heinrich Fischer (18). Die Gehstreckenlänge betrug 2 km, die Gehgeschwindigkeit 5,5 km/h. Die auf dem Handydisplay wiedergegebenen Einzelwerte wurden mit einer Digitalkamera gefilmt und danach zur Auswertung in Super-Slow-Motion ausgelesen. Dasselbe Verfahren durchlief ein Kompressionsstrumpf (KKl-2).
Bis zu einer Gehstreckendistanz von ca. 300 m liegen Fischer-Verband und Kompressionsstrumpf (KKl-2) mit intermittierenden Druckamplitudenspitzen von 80 mmHg gleichauf. Danach entwickelt sich die Phase 2 des biphasischen Druckanstiegs unter dem nicht elastischen Verband: Die Druckamplitudenspitzen steigen kontinuierlich weiter an, bis nach ca. 800 m ein Plateau mit einem durchschnittlichen Spitzendruck von 200 mmHg erreicht wird. Die Druckspitzendauer beträgt < 1/10 Sekunde.
3 Kraftquellen sind an der Druckgenese bei der Kompressionstherapie beteiligt: 1. der externe Anpressdruck des Kompressionsmediums, 2. die interne Kraft aus der Filament-Gleit-Schwellung der kontrahierenden Muskulatur, 3. die interne Kraft aus der zeitverzögert einsetzenden belastungsabhängigen vaskulär-metabolischen Pumpeffekt-Schwellung der Muskulatur. Sie ist verantwortlich für das spezifische Phänomen des biphasischen Druckanstiegs unter nicht nachgiebigen Kompressionsmedien. Der Anpressdruck (Anlagedruck) des Kompressionsmediums wirkt bei der nachgiebigen und nicht nachgiebigen Kompressionstherapie gleichermaßen. Die beiden internen Kraftquellen (Filament-Gleit-Schwellung und Pumpeffekt-Schwellung) summieren sich und entfalten nach Gehstrecken größer 800 m biphasisch eine Kraft, die je nach Steifheit des nicht nachgiebigen Materials im Binnenraum unter dem Verband (für < 1/10 sec.) vollständig in Druckkraft übergeht. Unter einer nachgiebigen Kompression verpufft diese Energie zum größten Teil in der Elastizität des textilen Materials. Beim flotten und ausgedehnten Gehen entwickeln sich deshalb (biphasisch) signifikant höhere Druckamplituden als unter elastischer Kompression. Als Resümee behält der alte phlebologische Leitsatz (15) “Therapie mit nicht nachgiebigen Verbänden und einem Laufprogramm, Halten des Ergebnisses mit Kompressionsstrümpfen” weiterhin seine berechtigte Gültigkeit.
Arbeitsdruck, Ruhedruck, Grenzflächen-Druckmessung, Biphasische Druckentwicklung, Filament-Gleit-Schwellung, Pumpeffekt-Schwellung, nicht nachgiebiger Kompressionsverband, nachgiebige textilelastische Kompression.
Adjustable Compression Wraps are Non-Inferior to Custom-Made Flat Knit Compression Stockings in the Maintenance Phase of Complex Decongestive TherapyPhysikalische Medizin, Rehabilitationsmedizin, Kurortmedizin 2020
Evidence supports the use of adjustable compression wraps (ACW) in the intensive phase of complex decongestive therapy (CDT), whereas evidence of its use in the maintenance phase of oedema therapy is sparse.
Randomised controlled non-inferiority trial in the maintenance phase of oedema therapy (CDT phase II) of symmetric lymphostatic oedema of the lower leg. Oedema therapy was performed with ACW and custom-made flat knit compression stockings (FCS) as a reference therapy in parallel over 3 days in n = 30 subjects. The primary outcome was lower leg volume as measured with perometer. Safety of ACW self-application and the patient perspective were secondary outcomes.
ACW is non-inferior to custom-made FCS in CDT phase II of lymphostatic lower leg oedema. The differences of volume effects lie within the apriori defined equivalence interval of ± 50 ml (p = 0.163; 95 %-CI [ − 38.2; + 6.8]). Self-administration of ACW has shown no relevant side effects. ACW are easier to put on and off, while wearing comfort is comparable.
ACW are an alternative therapy option in the maintenance phase of CDT. Self-application seems to be safe, subject to diligent instruction of patients. Patients with difficulties putting on and off compression stockings could benefit from the use of ACW. Patients with pronounced limb volume may need to wear shoes with bigger sizes when wearing ACW. Further research with a longer observation time is to follow.Further languages
A small scale quality improvement study trialling the use of a monofilament-fibre (Debrisoft®) debridement lolly on chronic ulcersWounds UK 2020 16(1)
A small-scale quality improvement study to determine the clinical effectiveness and patient satisfaction of the long-handled monofilament fibre (Debrisoft®) debriding lolly on foot ulcers that were considered to be slow healing in nature.
This was a non-comparative, small-scale quality improvement study conducted on ulcers with slough (non-fibrous) at the ulcer base. The longhandled monofilament fibre (Debrisoft®) debriding lolly was used to treat seven patients during ulcer management, following the Trust's guidance for podiatric ulcer treatment.
Improvement was noted to the majority of ulcers within the second to third week and visible changes were evident, particularly in healing times and slough reduction. Both user and patient satisfaction were high.
The long-handled monofilament fibre (Debrisoft®) debriding lolly provides an easy-to-use method of debriding foot ulcers. It allows easy access to difficult areas and enables the healing mechanism to commence. Patients verbally reported positive satisfaction when the long-handled monofilament fibre (Debrisoft®) debriding lolly was used.Products Debrisoft Lolly
Mechanical debridement of leg ulcers and the surrounding skin using a monofilament fibre debridement pad designed for larger wounds and surface areasPoster presented at Wounds UK 2019 04.11.2019 Harrogate, UK
In the management of leg ulcers and hyperkeratosis of the surrounding skin, it is not uncommon for them to affect very large areas of the leg. The large size also leads to an increase in the level of exudate and the amount of devitalised tissue. As a result, a larger amount of material is needed to loosen and remove the devitalised tissue than is the case with smaller wounds. The size of the area of the wound that can be treated at the same time is limited by size of your debridement device. An already well established and proven  monofilament fibre debridement pad* has been increased in size to tackle this issues. The handling has been improved  by adding a mitten on the back side. To evaluate the performance of this debridement pad optimised for larger wounds and the surrounding skin, a small case series was performed.
For the case series leg ulcers of various origins that needed debridement were treated once or over a longer period of time with the larger pad when indicated. The treatment was documented both photographically and in writing. The patients gave their written consent to the preparation of the case studies and the use of the image material.
A 64 year old female patient with mixed aitiology leg ulcers with a history of reoccurrence since 2000 and has been in our treatment since 2015. Over the least 5 years she has ulcers spreading to cover the entire gaiter area of both lower legs. The wounds were colonised regularly with bacteria/biofilm. The patient suffers from pain of 8-9 on the VAS scale especially at night but the debridement was well tolerated and biofilm removal effective.
A 83 year old female patient suffering from venous leg ulcers since August 2017 and has been in our treatment since April 2019. There were many small superficial ulcers and erosions with hyperkeratosis on the whole lower leg and a red inflammation of the wound surrounding area due to infection. After a few uses of the debridement pad most of the ulcers and erosion were healed.
A 70 year old male patient with venous leg ulcer on his left lower leg which has been present for 4 month and in our treatment since April 2019. Several ulcers had firmly adhering slough and necrotic tissue. After the debridement more granulation tissue became visible.
A 64 year old patient suffering from obesity associated leg ulcers. The ulcer on the left lower leg occurred in November 2017 as a result of a trauma from a fall and was extremely painful making wound dressing difficult. The debridement with the larger pad was well tolerated and efficient. Some additional surgical debridement was necessary.
A 70 year old male patient has been treated since July 2017 due to ulcers spreading to cover the entire gaiter area of both lower legs. The ulcers had almost healed leaving the wound surrounding skin covered with hyperkeratosis. Debridement with the larger pad was pain-free for the patient with some superficial bleeding because large, adhered pieces of the hyperkeratosis have been removed.
Due to the increased size of the monofilament fibre debridement pad, large areas could be treated very efficiently. Most of the time one pad was sufficient, even for ulcers spreading to cover the entire gaiter area. For the treatment of smaller wounds or areas, smaller versions of the device are available and might be more efficient. The mitten on the back of the pad enables the user to easily use the whole surface of the debridement pad at the same time. As a result, a much larger area could be treated quicker than it would have been possible with a smaller device. In addition, the enlargement of the device is accompanied by an increase in the absorption capacity for exudate, slough and debris.
The larger monofilament fibre debridement pad is a useful addition to the existing smaller versions. Especially useful and effective for bigger wounds and areas.Products Debrisoft Pad