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    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:

    1. Poster

      Assessing the performance of an improved superabsorbent wound dressing:a multi-centre clinical evaluation

      Poster presented at CICA 2019 20.01.2019 Paris, France

      Introduction

      This national, multicentre patient evaluation examines the enhancements that have recently been made to a superabsorbent dressing* and how this product improvement** has led to enhanced performance and improved patient related outcomes. The enhancements are a wider border and more ergonomic shape and a new structure to the superabsorbent polymer which increases absorbency.

       

      Method

      The recently developed and improved superabsorbent wound dressing was evaluated in six clinical sites on 27 patients with wounds requiring management of exudate of varying levels.

       

      Results

      The mean age of the patients who participated was 70 years and the main wound type was leg ulcer. At the start of the evaluation the surrounding skin was mostly reported to be macerated and/or red and excoriated. Exudate levels were light in 4 cases, moderate in 12 cases and heavy in 11 cases. The improved superabsorbent was used on its own as a primary dressing in only 5 cases and in combination with another primary dressing in 15 cases (7 did not answer the question). A topical antimicrobial was combined with the new superabsorbent in 60% of cases and a contact layer in 20% of cases. It was used under full or reduced compression in 21 cases. In most cases the improved superabsorbent replaced either another superabsorbent or absorbent dressing. The frequency of dressing changes varied from daily to weekly prior to the evaluation with 7 clinicians stating that the new and improved superabsorbent had reduced the frequency of dressing changes. The others either did not comment on this, or did not see a change. Other parameters were rated as good and very good and are outlined in Table 1.

       

      Discussion

      Although the improved superabsorbent dressing includes a very effective wound contact layer, 20% of cases used the product in combination with another contact layer. Use with another contact layer would not be recommended as this is not necessary and increases costs. Superabsorbent dressings are designed for the management of medium to high levels of exudate and should not be considered in low exudate.

       

      Conclusion

      The new and improved superabsorbent wound dressing demonstrated clear advantages for clinicians managing exudate. The patient shown in Figure 1 - 3 is still being managed with the improved product as this is the only dressing he doesn’t react to.

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    2. Journal article

      Effect of non-adhering dressings on promotion of fibroblast proliferation and wound healing in vitro

      Scientific reports 2019 9(1) 4320

      Non-adhering dressings are commonly used during granulation, tissue formation, and re-epithelialization. Elucidating cytotoxic effects and influence on proliferation/migration capacity of cells like fibroblasts is of interest. Dressings' effects were investigated by comprehensive in vitro approach: (1) MTT assay measuring cell viability after direct contact, (2) ATP assay determining effects on cell proliferation, and (3) scratch wound assay featuring an in vitro wound healing model. One cotton-based dressing with vaseline (vas) was included in the study and four polyester dressings containing vas and technology-lipido-colloid matrix (TLC), carboxymethylcellulose (CMC), hydrocolloid (HC), or glycerin (gly) as additives. A polyamide dressing with vas + CMC and three silicone-based dressings (AT, CC, M) were tested. Polyester + vas + CMC did not negatively affect cell viability or proliferation but it was found that fibroblast layers appeared more irregular with decreased F-actin network structure and tubulin density possibly leading to hampered scratch closure. Silicone AT, polyester + gly and polyamide + vas + CMC caused distinct cell damage. The latter two further reduced cell viability, proliferation and scratch healing. From the overall results, it can be concluded that cotton + vas, polyester + TLC, polyester + vas + HC and the silicone dressings CC and M have the potential to prevent damage of newly formed tissue during dressing changes and positively influence wound healing.

      PMID 30867534
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    3. Journal article

      Examination of the effects of a new compression garment on skin tissue oxygenation in healthy volunteers

      Journal of wound care 2019 28(7) 429435

      OBJECTIVE

      Compression devices have been shown to reduce venous stasis, increase blood flow and skin tissue oxygenation (StO2), promoting healthy tissue. This study aimed to explore the efficacy of a new compression garment in three different positions in healthy adults.

       

      METHODS

      In this quantitative study, potential participants were screened and recruited using the Physical Activity Readiness Questionnaire (PAR-Q, Canada). Participants attended three separate, one-hour sessions to evaluate StO2 in supine-lying, chair-sitting and long-sitting positions. StO2 was recorded for 20 minutes pre-, during and post- a 20-minute intervention using a compression garment, TributeWrap (Lohmann-Rauscher, Germany). A repeated-measures analysis of variance (ANOVA) was followed by post-hoc pairwise comparisons.

       

      RESULTS

      A total of 28 healthy volunteers took part (aged 24.6 ±8.4years; 13 males, 15 females). A significant difference was seen between the three positions (p<0.001). Chair-sitting had the lowest StO2 pre-intervention, increasing StO2 significantly (32.25%, p<0.001) during wear of the compression garment (24.8% higher than baseline post-intervention). No significant difference was seen between long sitting and supine-lying (p=1.000). In contrast, long-sitting and supine-lying StO2 was higher pre-intervention compared with chair-sitting and only increased post-intervention (11% and 16.8% respectively, p<0.001) compared with baseline.

       

      CONCLUSION

      The compression garment significantly increased StO2 levels in both seating positions. Further studies are required to determine if increasing StO2 through short intervention sessions with this device has the potential to improve self-management of tissue health in individuals with reduced mobility, oedema or venous insufficiency.

      PMID 31295092
    4. Poster

      A new developed surgical wound dressing*:Final data of a clinical study with 395 patients

      Poster presented at Wounds UK 2018 05.11.2018 Harrogate, UK

      Introduction

      For an optimal wound healing it is necessary to have a reliable protection of the wound. Therefore a surgical wound dressing has to be used, that fulfils this requirement. Being almost painless during dressing change and conformable for the patients is also a huge benefit. A new surgical wound dressing [Picture 1] has been developed to meet these properties. This study has been performed to evaluate the product in daily wound care. After showing the preliminary results last year, this poster presenting the final results of our study.

       

      Method

      A multicentre, national Post-Market Clinical Follow-up-study (PMCF) has been performed. 46 professional users (medical doctors, nurses and healthcare specialists) were using the surgical wound dressing on 395 patients. For this study they have been asked to describe the performance of the product, the experience of themselves and the experience of patient while the treatment. The patients, were suffering on postoperative wounds, incisions, lacerations, abrasions, skin affliction and other types of wounds [Graph 1] at a variety of localizations [Graph 2]. For the treatment the professional users could choose between different product sizes from 7 x 5 cm up to 10 x 34 cm. The users were instructed to fill out a written questionnaire to document the results. The questionnaire was developed and provided by the sponsor of the study and used a six-point Likert scale (very good = 1, good = 2, satisfactory = 3, sufficient = 4, deficient = 5, insufficient = 6).

       

      Results

      The adherence of the surgical wound dressing on the skin was rated as “very good”. The average application time was 1-3 days. The fit of the product to the treated localisation was rated as “very good” in general. Even at difficult localisations like foot, head, hand or knee the fit was rated as “good” or better. The germ-free application, the protection of the wound as well as the personal safety of the user was rates as “very good” [Graph 3]. More than 90% of the users rated the simplicity and the speed of the application as “very good” or “good”. More than 95% of the patients rated the wearing comfort as “very good” or “good” [Graph 4]. 88% of all patients experienced no pain during the dressing changes. The remaining 12% had average mild pain of 3 on the Numeric Rating Scale (NRS) [Graph 5].

       

      Discussion

      This study confirmed the suitability of the new surgical wound dressing for a variety of indications and localizations. The product was predominantly used for postsurgical wounds, but also for a variety of other acute wounds. Together with the fact, that there were no preferred localisation and the good assessment of the fitting accuracy, this shows the flexibility of the wound dressing. Due to the very good wearing comfort and the almost pain-free dressing changes the acceptance by the patient is very high. The wound dressing is also user friendly, due its simplicity and effectiveness. It also promotes wound healing by protecting it against contamination and mechanical damage.

      Products Curapor
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    5. Poster

      A multi-therapy approach using wound bed preparation, super-absorbent dressing and compression to achieve a quick and effective exudate solution for venous leg ulcers

      Poster presented at Wounds UK 2018 05.11.2018 Harrogate, UK

      Introduction

      This clinical evaluation was conducted to validate the usage of a three step treatment plan for patients with highly exuding leg ulcers which included monofilament fibre pad, superabsorbent dressing and cohesive, short stretch bandages. The primary outcome measure was a reduction in the levels of exudate of patients with highly exuding leg ulcers with a simple three step approach. The secondary outcome measures were reduction in nurse visits, reduction in pain, reduction in materials cost, increase in patient quality of life.

       

      Method

      The trial design was a planned sample size of 10 patients over a 4 week period with a review at 2 weeks. The inclusion criteria was that all patients in the trial must have had a full holistic assessment with an Ankle Brachial Pressure Index (ABPI) of between 0.8 and 1.3. Patients must be willing to tolerate a full compression system and must be experiencing issues with ‘leaky legs’/ highly exuding leg ulcers. The exclusion criteria included non-concordant patients and patients with an ABPI of lower than 0.8 or higher than 1.3

       

      Results

      Three patients who had previously been in a reduced compression system became non concordant towards the end of the trial due to wanting to be more comfortable and although had significant improvements in wound healing which have been included in the results, could not be included in the cost analysis. One patient was hospitalised during the trial and therefore had to be removed from the analysis. Eight patients have had the leg ulcer for longer than 12 months and 90% of patients were in no compression or a reduced compression system. Regarding the Doppler assessment, 100% of patients had a doppler assessment and 90% of patients had a doppler reading between 0.8 - 1.3. Before the evaluation started, 5 patients had very high exudate and 5 patients had moderate exudate levels. Fifty percent of patients had had those levels of exudate for over 6 months and forty percent of patients for between 3-6 months. After the evaluation one patient was admitted to hospital for an unrelated reason and so couldn’t complete the trial. From the remaining 9 patients 7 had dramatically reduced exudate levels to low. When looking at the patient pain scores pre and post evaluation, 8 out of the 10 patients recorded a pain score pre evaluation and 6 post evaluation. All 6 patients reported a reduction in pain with an overall 45% reduction in pain. Reduction in wound size area was recorded in 9 cases and in all 9 cases there was a reduction in wound size of between 0.5cm and 5.5cm in dimensions. During the 4 week evaluation in 9 patients, there was a 58% reduction in nurse visits.The total number of nurse visits per week across 6 patients before the clinical evaluation was 24 and this reduced to 11 visits per week after the clinical evaluation. Across the same 6 patients there was a weekly product cost saving of £145. Before the clinical evaluation started 9 out of 10 patients stated that their leg ulcer affected the quality of their life. At the end of the 4 week evaluation, 7 out of 9 patients reported an improvement in their quality of life and expressed some thought provoking comments.

       

      Discussion and conclusion

      Many patients who have venous leg ulcers experience high levels of exudate and pain and this may lead the healthcare professional and patient to decide that implementing full, therapeutic compression is not possible. They may opt for ‘reduced compression therapy’ or ‘light bandaging’ thinking some compression is better than nothing. This evaluation clearly demonstrated in a small group of patients that by implementing a three step solution of effective wound bed preparation using a monofilament fibre pad, a high quality superabsorbent dressing and full, therapeutic compression has a dramatic effect on exudate levels and pain experienced by the patients. This leads to reduced nursing visits, reduced costs and ultimately, an improved patient experience and quality of life.

    6. Poster

      A clinical evaluation of a hydroactive fibre dressing in the management of lower limb chronic wounds in a primary care setting.

      Poster presented at Wounds UK 2018 05.11.2018 Harrogate, UK

      Introduction

      The management of chronic wounds in primary care has been under the spotlight for several years (Guest et al, 2015). For the patient, the biggest challenge is exudate. For the nurse, the biggest challenge is time, which can be indirectly affected by exudate management.

      The main aim of this clinical evaluation was to see if exudate and the number of dressing changes could be influenced by changing the wound dressing to a new hydroactive fibre dressing* to the UK. Secondary aims were to evaluate the clinician and patient experiences using the new hydroactive fibre dressing.

       

      Method

      Ten patients were selected in a primary care wound clinic with moderate to high levels of exudate, suitable for a hydroactive fibre dressing. The mean age of the patients was 72 years and there were 9 leg ulcers and 1 diabetic foot ulcer. Seven of the patients had had their wounds for between 1 and 6 months and the other 3 for 1, 3 and 5 years. The wound bed was granulating in 4 patients and sloughy in 6 patients. The skin condition in 9 patients, despite the previous wound dressings used was macerated, excoriated and red/inflamed. Five patients had been using the UK market leading hydrofiber wound dressing** prior to the new hydroactive fibre dressing. The other 5 patients had been using an antimicrobial wound dressing. The hydroactive fibre dressing was evaluated over 4 dressing changes and data was collected on a data collection form by the lead author. Eight out of the 10 patients received compression therapy, 6 with a cohesive short stretch bandage***. Nine out of 10 patients had a standard superabsorbent secondary dressing.

       

      Results

      Seven out of the 10 patients benefited from a reduced number of dressing changes over the evaluation period, 3 of which were previously using the UK market leading hydrofiber wound dressing. This was probably due to exudate levels reducing in all 10 patients over the evaluation period when using a 0-10 scale where 10 was the highest exudate level.

      Patient reported pain was measured using a 0-10 scale where 10 was the worst ever pain.

      Seven patients benefited for a reduction in reported pain, some patients by as much as 67%. When evaluating the performance of the new hydroactive fibre dressing compared to the previously used dressing, 100% reported very good in ease of application, conformability, reduced dressing shrinkage, patient comfort from softness of gel, ease of removal in one piece and non-adherence. For wound condition and surrounding skin condition 90% reported good or very good. Using a 0-10 scale to evaluate clinician and patient satisfaction where 10 was the greatest satisfaction, 100% evaluated both patient and clinician satisfaction as either 8 or 9. On 9 out of 10 occasions, the author would recommend and/or use the new hydroactive fibre dressing again and on one there was no comment.

       

      Conclusion

      Whilst this is a small clinical evaluation, results demonstrate that the new hydroactive fibre wound dressing performed well when compared to the UK market leading hydrofiber dressing and antimicrobials in 10 patients with lower limb chronic wounds. Key findings were reduced exudate levels leading to reduced number of dressing changes, reduced patient reported pain during treatment and it was used successfully under compression therapy. The author and the patients were very satisfied during the evaluation period and patients commented on greater comfort, containment of exudate and improved quality of life due to better exudate management. The author commented that the UK market leading hydrofiber dressing ‘tends to adhere to the wound bed and proves difficult to remove whereas the new hydroactive fibre dressing came off with ease’.

    7. Poster

      A comparative study of a gel forming wound contact layer with a wound contact layer with Safetac technology in patients who had undergone toe nail avulsion

      Poster presented at Wounds UK 2018 05.11.2018 Harrogate, UK

      Introduction

      This comparative clinical evaluation was conducted to compare a gel forming wound contact layer with the market leader wound contact layer with Safetac. Wound contact layers are a popular choice of wound dressing as they can be used through many stages of the wound healing process¹. There is however, a considerable difference in price depending on which type of wound contact layer you use.

       

      Method

      The comparative clinical evaluation was conducted in podiatry out patients clinics. One patient group used a gel forming wound contact layer and the other clinic continued to use their existing product, a wound contact layer with Safetac. All of the patients had undergone toe nail avulsion and the dressings were used post-procedure. Thirty eight patients were recruited in total, 20 in the gel forming wound contact layer group and 18 (four double procedures) in the wound contact layer with Safetac group. Data was collected on an evaluation form and measured the performance of the dressings, pain assessment on dressing removal, clinician satisfaction and patient satisfaction. It was also recorded if the user would recommend and continue to use the trial product.

       

      Results

      When evaluating the ease of application of the dressings, 100% of users in both groups said that the gel forming wound contact layer and wound contact layer with Safetac were either good or very good. When evaluating the conformability of the dressings, 100% of users in both groups said that the gel forming wound contact layer and wound contact layer with Safetac were either good or very good. When evaluating the draining of exudate through the dressings, 100% of users in both groups said that the gel forming wound contact layer and wound contact layer with Safetac was either good or very good. When evaluating patient comfort and softness of the dressings, 100% of the wound contact layer with Safetac group were either good or very good and 90% in the gel forming wound contact layer. When evaluating ease of removal of the dressings, 100% of the wound contact layer with Safetac group were either good or very good and 95% in the gel forming wound contact layer. Pain assessment was completed using a numerical scale where 0 was no pain and 10 was the worst ever. In the gel forming wound contact layer group, 95% scored 0 for pain on removal of the dressing and 93.75% scored 0 in the wound contact layer with Safetac. Clinician and patient satisfaction was measured using a numerical scale where 10 was the greatest satisfaction. In the wound contact layer with Safetac group, 100% scored 10 for both clinician and patient satisfaction. In the gel forming wound contact layer group, 95% scored 10 for both clinician and patient satisfaction. When users in the gel forming wound contact layer group were asked if they would recommend or continue to use the dressing, 100% said yes, they would.

       

      Conclusion

      This comparative clinical evaluation demonstrated that the more cost-effective gel forming wound contact layer performed very well when compared with the market leader, as a primary layer for the postoperative dressing, in the management of toe nail avulsions. The gel forming wound contact layer also offers other wound healing advantages as it contains a hydrocolloid, which has both wound and skin advantages².

      Products Lomatuell Pro
    8. Poster

      Casereport: Endoskopische Vakuumtherapie mittels modifizierter Drainagefolie bei infizierter Pankreasnekrose

      Poster presented at annual meeting Viszeralmedizin NRW 2018 07.06.2018

      Hintergrund:

      Zur endoskopischen Vakuumtherapie infizierter Pankreasnekrosen existieren nur wenige Fallbeschreibungen. Die eingesetzte Drainagefolie (Erstbeschreibung Loske et al. 2016) wurde weiter modifiziert.

       

      Der Fall:

      Ein 58-jähriger Pat. stellte sich 4 Wochen nach erstem Pankreatitisschub vor. Im MRT zeigte sich eine 8x5 cm grosse Pseudozyste am Pankreascorpus mit angrenzender Nekrose. Die Pseudozyste wurde zunächst transgastral mit 2 Stents drainiert, der Patient beschwerdefrei entlassen. 3 Wochen später erfolgte eine Wiederaufnahme bei Sepsis, eine Therapie mit Imipenem wurde eingeleitet. Im CT zeigte sich eine infizierte Nekrosehöhle angrenzend an die Zystendrainage. Die Stents wurden entfernt und ein selbstexpandierender Pseudozystenstent (15x20 mm, Fa. Microtech) in den Sinustrakt eingelegt (Tag 0). Es kam zu Eiteraustritt, bei Taschenbildung im Sinustrakt war jedoch noch kein sicherer Zugang in die Nekrosehöhle geschaffen. Nach Bougierung wurde ein beschichteter 60 x 10 mm Gallengangsstent in den Sinustrakt eingelegt. An Tag 0, 2, 3 und 6 wurde Nekrosematerial endoskopisch abgetragen und die Höhle gespült. Bei einmaliger arterieller Blutung aus dem Fistelkanal erfolgte eine Blutstillung mittels Elektrokoagulation und Kompression über einen Gallengangsballon. An Tag 8 wurde bei weiterhin eitrigem Nekrosematerial eine endokopische Vacuumtherapie eingeleitet. Die Einlage des Esosponge®-Systems war bei Schleifenbildung nicht möglich, sodass eine modifizierte Drainage angelegt wurde: eine Magensonde ohne Spitze wurde mit Suprasorb®-CNP-Drainagefolie umwickelt und mit Faden durchstochen. Sie liess sich über Führungsdraht weit in die Nekrosehöhle vorbringen (Sog -60mmHg, vgl. Loske: Folie umwickelt, ohne Führungsdraht). An Tag 9 erfolgte ein Wechsel des Vakuumsystems. Hierbei zeigte sich eine beginnende Granulationsbildung im Fistelkanal und in der Nekrosehöhle. An Tag 12. wurde die Vacuumdrainage bei sauberer Fistel nach 5 Tagen Therapiedauer entfernt. Bei Abschlusskontrolle (Tag 14) war die Fistelöffnung verschlossen, Entzündungszeichen bestanden nicht mehr. Im CT zeigte sich eine Rückbildung der Nekrosehöhle. Der Pat. konnte nach 5 Wochen entlassen werden. Zu einem erneuten Entzündungsschub kam es nicht.

       

      Fazit:

      Die endoskopische Vakuumtherapie kann eine interventionelle Nekrosektomie unterstützen und die Therapiedauer deutlich verkürzen. Limitierend sind Blutungen, die mittels Ballonkompression und Koagulation gestillt werden können.

    9. Poster

      IN VITRO ASSESSMENT OF THE COMPATIBILITY OF APPLICATION OF A PU FOAM* AND DRAINAGE FOIL** DURING NPWT USING DIFFERENT PUMPS

      Poster presented at EWMA 2018 09.05.2018

      Aim:

      NPWT has been advocated for virtually all kinds of acute and chronic wounds. Treatment is based on local negative pressure applied to the wound surface. NPWT is mainly carried out using open-cell polyurethane foams. It could be shown that cells show a significant tendency to grow into these foams which can be inhibited by application of drainage foil** without interfering with induction of cell migration. It is of interest to investigate if this combination is robust and workable with different vacuum pumps***.

       

      Method:

      Drainage foil** was placed on fibroblast 3D-cultures in combination with largepored PU foam*. Assemblies were positioned in Petri dishes and sealed with air-tight film after medium supply and vacuum pumps*** were connected. Experiments were carried out at -80mmHg and -120 mmHg for 48h. Cell viability and ingrowths of cells into samples was

      determined.

       

      Results / Discussion:

      Combination of drainage foil** and PU foam* samples during NPWT with different vacuum pumps*** led to the same cellular responses in vitro. With the PU foam* alone, cells did not stop at the pellicle edge but continued to migrate into the

      dressing. In contrast, placement of drainage foil** between collagen pellicle and PU foam* inhibited ingrowths of cells into the foam.

       

      Conclusion:

      It was shown that combination of drainage foil** with PU foam* for NPWT is workable with pumps from different manufacturers***. Ingrowths of cells into large-pored foams can be inhibited in vitro by application of drainage foil**. In vivo this may prevent disruption of newly formed tissue during dressing changes.

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    10. Poster

      Evaluating the removal of bacteria and biofilm with monofilament fibre debridement technology, compared to a cleaning product using a wound intelligence device

      Poster presented at EWMA 2018 09.05.2018 Krakow, Poland

      Aim:

      To evaluate the performance of Monofilament Fibre Debridement Technology compared to a cleaning cloth in the removal of bacteria and biofilm using a wound intelligence device which leverages the principles of fluorescence.

       

      Method:

      Patients were selected with chronic wounds who demonstrated signs that biofilm was the primary cause of the wound being static or slow to heal. A monofilament fibre debridement pad was used to mechanically debride the chronic wounds and expedite wound bed preparation. The same procedure was repeated using a cleaning cloth with poloxamer following manufacturer’s instructions for use. A wound intelligence device was used to take images of fluoresce in bacteria ≥ 10⁴ CFU/g on the surface of the wound bed before and after using the monofilament fibre debridement pad and compared with the before and after images using the cleaning cloth.

       

      Results / Discussion:

      To date, eight patients have been recruited into the evaluation, four using the monofilament fibre debridement pad and four using the cleaning cloth. In all cases, images demonstrate that the monofilament fibre debridement technology has superior ability to removal bacteria and biofilm when compared to the cleaning cloth with poloxamer. Data collection continues.

       

      Conclusion:

      To date, the monofilament fibre debridement technology has shown better removal of bacteria and biofilm when compared with a cleaning cloth using fluoresce imaging in the evaluation.

      Products Debrisoft Pad