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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. 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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    2. Journal article

      Endoskopische Vakuumtherapie bei infizierter walled-off Pankreasnekrose

      Zeitschrift fur Gastroenterologie 2019 57(7) 852858

      Necrotizing pancreatitis remains a therapeutic challenge. Thirty-eight percent of all cases lead to an early organ failure and 15 % cause death. Interventions are necessary in 38 % 1.Due to lower mortality compared to open surgery, both endoscopic treatment and minimally invasive surgery are established 2.Endoscopic vacuum therapy can be an auxiliary method for this indication, with only a few case reports existing. Recommendation is still unclear, compared to standard methods like endoscopic necrosectomy, drainage and irrigation (see ESGE Guideline "Endoscopic management of acute necrotizing pancreatitis" 2018; Recommendation 4.2.8) 1.The actual case shows a successful endoscopic vacuum therapy of an infected walled-off pancreatic necrosis. A modified open-pore film drainage (OFD) is combined with endoscopic necrosectomy.

       

      Die nekrotisierende Pankreatitis ist nach wie vor eine therapeutische Herausforderung. 38 % der Fälle münden in ein frühes Organversagen, 15 % führen zum Tod. Interventionen werden in 38 % der Fälle nötig 1. Aufgrund geringerer Mortalität gegenüber der klassischen offenen chirurgischen Vorgehensweise sind endoskopische und chirurgische minimalinvasive Methoden etabliert 2. Die endoskopische Vakuumtherapie kann hier eine Ergänzungsmethode darstellen, zu der bisher nur wenige Fallbeschreibungen existieren. Ein fester Stellenwert gegenüber den Standardverfahren wie endoskopischer Nekrosektomie mit Lavage besteht derzeit noch nicht (vgl. ESGE-Guideline „Endoscopic management of acute necrotizing pancreatitis“, 2018; Abschnitt 4.2.8) 1.Der vorliegende Fall beschreibt eine erfolgreiche endoskopische Vakuumtherapie bei infizierter walled-off Pankreasnekrose unter Verwendung einer modifizierten Drainagefolie in Ergänzung zur Standardmethode der endoskopischen Nekrosektomie.

      PMID 31288281
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    3. Journal article

      Biofilm management using monofilament fibre debridement technology: outcomes and clinician and patient satisfaction

      Journal of Wound Care 2019 28(9) 608622

      Objective:

      Best practice in wound bed preparation and biofilm-based wound management includes debridement to create a clean wound bed and to assist in minimising the redevelopment of biofilm. Biofilm that is not removed inhibits healing and redevelops if not prevented from doing so with topical antimicrobial agents. Monofilament fibre debriding technology (MFDT) is used for effective and rapid mechanical debridement of loose material, slough and biofilm. The objective of this evaluation was to determine the clinical effect and consequential levels of health professional and patient satisfaction with the results of a biofilm pathway that included MFDT to achieve debridement.

       

      Methods:

      This non-comparative, open label evaluation was conducted in static and non-static wounds that required debridement. MFDT was used to debride in a two-week evaluation of a biofilm pathway. Wounds were debrided three times in week one and twice in week two. Each debridement was followed by treatment with an antimicrobial dressing. Other care included secondary dressings and compression delivered according to local practice, guidelines and formularies. After the clinical evaluation, health professionals were invited to complete an online survey of the clinical outcomes and their satisfaction with the biofilm pathway.

       

      Results:

      There were 706 health professionals who provided answers to the survey questions. Wound types evaluated were leg ulcers (67.4%), pressure ulcers (10%), dehisced surgical wounds (1.7%), diabetic foot ulcers (7.4%) and other wounds (13.4%). Of the wounds, 9% were reported as non-static despite the eligibility criteria. Not all wounds followed the pathway. The most frequently-used antimicrobial was silver. Non-antimicrobial products used included all-in-one dressings, other secondary dressings and compression. There was a change in 77% of wounds overall after two weeks. Change was reported almost equally for both static and non-static wounds. Health professionals who did or did not follow the pathway were ‘completely satisfied’ or ‘satisfied’ with the overall clinical outcome 96% and 95%, respectively. Of the patients, 77% were ‘completely satisfied’ or ‘satisfied’ with healing after following the pathway, as reported by the treating health professional.

       

      Conclusion:

      The biofilm pathway that includes MFDT appears effective. Wounds managed on the pathway were debrided effectively and healing progressed to the satisfaction of both health professionals and patients.

      Products Debrisoft Pad
      PMID 31513491
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    4. Journal article

      Role of endoscopic vacuum therapy in the management of gastrointestinal transmural defects

      World journal of gastrointestinal endoscopy 2019 11(5) 329344

      A gastrointestinal (GI) transmural defect is defined as total rupture of the GI wall, and these defects can be divided into three categories: perforations, leaks, and fistulas. Surgical management of these defects is usually challenging and may be associated with high morbidity and mortality rates. Recently, several novel endoscopic techniques have been developed, and endoscopy has become a first-line approach for therapy of these conditions. The use of endoscopic vacuum therapy (EVT) is increasing with favorable results. This technique involves endoscopic placement of a sponge connected to a nasogastric tube into the defect cavity or lumen. This promotes healing via five mechanisms, including macrodeformation, microdeformation, changes in perfusion, exudate control, and bacterial clearance, which is similar to the mechanisms in which skin wounds are treated with commonly employed wound vacuums. EVT can be used in the upper GI tract, small bowel, biliopancreatic regions, and lower GI tract, with variable success rates and a satisfactory safety profile. In this article, we review and discuss the mechanism of action, materials, techniques, efficacy, and safety of EVT in the management of patients with GI transmural defects.

      PMID 31205594
    5. 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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    6. 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.

    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

      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’.

    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

      Succesfull treatment of a 96 year-old patient with an infected wound after osteosynthesis

      Poster presented at EWMA 2018 09.05.2018 Krakow, Poland

      Aim:

      Complex case management in a fragile elderly patient to achieve an optimal outcome.

       

      Method:

      The 96 year-old female had a deep wound infection after osteosynthesis of her left ankle. In the hospital she was treated with negative pressure wound therapy (NPWT). Upon arrival on March 2, 2017 in the rehabilitation centre the wound surface was 8 x 3 cm, the wound bed contained 10% yellow and 90% granulation tissue with some hyper-granulation present. The wound edges were non vital and there was oedema in her left ankle. The surrounding skin was slightly red.

       

      Results:

      The patient received nutritional supplements twice daily. NPWT was discontinued and the treatment regime now comprised: Debridement using a monofilament1 pad, followed by cleansing with water and disinfection with an antiseptic. The peri-wound skin was protected with a spray on film, a collagen2 and an alginate3 dressing were covered with a superabsorbent pad fixed with an adhesive film dressing.4 Dressing changes were on average twice weekly. For compression 2 layers (20 mmHg) of a tubular compression5 system were applied during the day and reduced to one layer at night. Wound closure was achieved after 41 days of treatment. The patient continued with the compression system for another 6 weeks to protect the fragile area and to prevent oedema from reoccurring.

       

      Conclusion:

      Complex wound closure was achieved in a comfortable fashion that suited the individual needs of this elderly fragile patient.