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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

      Use of a monofilament debridement pad in the treatment of acne vulgaris

      Journal of Wound Care 2019 28(11) 780783

      Objective:

      Acne vulgaris (acne) presents with increased oil-sebum secretion and subsequent formation of comedones, papules, pustules and nodules. Skin cleansing is part of the daily routine to improve skin condition. A monofilament debridement pad has shown to be effective when used for wound debridement and skin cleansing in dermatological conditions. The pad may offer benefits when used for acne affected skin.

       

       

      Methods:

      The in vitro cleansing capacity of the monofilament fibre pad was analysed and compared with commercially available cosmetic pads. For this purpose, a sebum model consisting of glass plates coated with an oil-red-stained layer of artificial sebum was used. To gain clinical experience a case series evaluated cleansing efficacy of the monofilament debridement pad in combination with polyhexanide and sodium-hypochlorite based solutions. Over a period of four months, seven individuals suffering from retentive moderate facial acne who visited the dermatology clinic for their acne used the pad as necessary, ranging from twice weekly to daily, dependent on the sensitivity of the patient's skin condition.

       

      Results:

      The in vitro study exhibited a significantly better cleansing efficacy of the monofilament debridement pad compared with the cosmetic pads. After single use of the pad subject scores on sebum reduction revealed excellent/very good in 42.9% and acceptable in 57.1% of cases. After repeated use of the monofilament pads scores on sebum reduction of excellent/very good were given in 85.7% and acceptable in 14.3% of cases. Subject scored handling of the pad and comfort during use also received favourable ratings.

       

      Conclusion:

      These initial results show the potential of the monofilament debridement pad for cleansing of acne-prone and acne affected skin. More robust studies are needed to confirm these results.

      Products Debrisoft Pad
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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. 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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    4. 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
    5. 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’.

    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

      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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    8. 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.

    9. Poster

      NON-ANTIBIOTIC ANTIMICROBIAL TECHNOLOGY WOUND DRESSINGS EXERTING AN ANTIBACTERIAL EFFECT ON PSEUDOMONAS AERUGINOSA AND A STAPHYLOCOCCUS AUREUS BIOFILM IN VITRO

      Poster presented at EWMA 2018 09.05.2018 Krakow, Poland

      Aim:

      Increased bacterial loads on the wound surface amplify and/or perpetuate a proinflammatory environment. It was suggested that lower probability of healing is seen when ≥4 pathogens are present. Biofilm formation further lowers the probability of healing. Hence, it was postulated that it is necessary to create conditions that are unfavourable to microorganisms and favourable for host repair mechanisms. Dressings featuring active antimicrobial agents or a passive antimicrobial mechanism may help in the treatment of chronic wounds.

       

      Method:

      DACC-coated1, SAP2, activated-charcoal/Ag3, and biocellulose/PHMB4 dressings were investigated. Antibacterial activity against P.aeruginosa was tested according to JISL1902:2002. S.aureus biofilm was cultivated on glass plates, covered with dressings, and incubated for 24h at 37°C. Biomass was evaluated directly after dressing removal and following 48h regrowth period using the alamar blue assay.

       

      Results / Discussion:

      All dressings displayed complete inhibition of P.aeruginosa, rated as strong antibacterial activity according to JISL1902:2002 (log-reduction>3). Treatment of S.aureus biofilm with the dressings efficiently reduced biomass and significantly less viable bacteria were observed. However, only the biocellulose/PHMB4 dressing exhibited a remanescent effect and was able to inhibit biofilm regrowth over 48h.

       

      Conclusion:

      Antimicrobial dressings can decrease multiplication of bacteria by passive mechanisms based on securely binding microbes in or to the dressing as observed for DACC-coated1 or SAP2 dressing. Dressings actively releasing agents like Ag+ or PHMB have additional effects reaching bacteria beyond direct dressing contact. Here, PHMB was found to be superior to Ag+ demonstrating a remanescent effect and preventing biofilm regrowth.

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    10. Poster

      BINDING CAPACITY OF TWO POLYACRYLATE SUPERABSORBER DRESSINGS FOR THE INFLAMMATORY PROTEASES PMN ELASTASE AND MMP-2 IN VITRO

      Poster presented at EWMA 2018 09.05.2018 Krakow, Poland

      Aim:

      Non-healing wounds contain elevated levels of neutrophil elastase and matrix metalloproteinases (MMPs) which are responsible for degradation of extracellular matrix and growth factors. These destructive processes prevent wound closure and lead to persisting wounds. Binding of these proteases contributes to the treatment of chronic wounds. The aim of this study was to compare the binding capacity of two polyacrylatesuperabsorber dressings* for elastase and MMP-2 in vitro.

       

      Method:

      Samples of SAP* and SAP Pro** were cut (0.5 cm2), taken in a final volume of 1mL of protease solution (PMN elastase: 250ng/mL; MMP-2: 4000pg/mL), and incubated up to 24h at 37°C. Concentrations of unbound protein were determined by specific immunoassays for PMN elastase and MMP-2. In addition, it was checked if proteases can be eluted from the dressing samples subsequently.

       

      Results / Discussion:

      SAP* exhibited high binding capacity for both proteases. After 24h elastase concentrations were significantly reduced about 95% (p<0.001) and MMP-2 amounts completely abolished (100%, p<0.001). Only marginal amounts of elastase andMMP-2 could be eluted from the samples after incubation. SAP Pro** demonstrated a comparable high binding of elastase and MMP-2. No distinct differences in the performance of the dressings were noted.

       

      Conclusion:

      The polyacrylate superabsorber dressings SAP* and SAP Pro** are able to shortly bind large amounts of elastase and MMP-2 in vitro. Elution of the dressing samples revealed a strong, possibly irreversible binding of both proteases. Decrease of these matrix degrading proteases should aid establishment of a physiological wound milieu in vivo and thus support the healing process.

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