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Clinical Newsletter

Regular updates on our latest clinical studies.

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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

    A case series report using a gel forming wound contact layer and monofilament fibre debridement technology in the management of chronic wounds

    Poster presented at EWMA 2018 09.05.2018 Krakow, Poland

    Aims

    To evaluate the performance of a gel forming wound contact layer* in static or slow-to-heal chronic wounds following wound bed preparation using monofilament fibre debridement technology**.

     

    Methods

    Eleven patients (9 females, 2 males) were selected with low to moderately exuding wounds – 10 of which were leg ulcers. The mean age was 71 years. All patients underwent wound bed preparation using monofilament fibre debridement technology at dressing changes followed by application of a gel forming wound contact layer. The patients were followed up weekly or twice weekly for five dressing changes or until healed. Both quantitative and qualitative parameters were measured at each dressing change.

     

    Results/Discussion

    In all cases, the chronic wounds went on to show positive signs of healing, with many reducing greatly in size or healing.

    The gel forming wound contact layer resulted in 100% reduction in pain scores during treatment, 100% rated very good application and removal (non-adherent) and 100% rated very good or good improvement of the condition of peri-wound skin.

    Results demonstrated very high patient and clinician satisfaction scores with 90% receiving 8 – 10 out of 10.

     

    Conclusion

    The gel forming wound contact layer proved easy to use, safe, effective and highly recommended by patients and clinician.

  2. Poster

    A review of monofilament fibre technology in the management of a variety of dermatological conditions

    Poster presented at EWMA 2018 09.05.2018 Krakow, Poland

    Aim:

    To review the evidence supporting the use of Monofilament fibre debridement technology (MFDT) in dermatological conditions.

     

    Method:

    MFDT has been successfully used for 7 years in the debridement and management of chronic wounds¹ and hyperkeratosis². In recent years clinicians have been utilizing the MFT in specific dermatological skin conditions.

     

    Results / Discussion:

    MFDT has been shown in case studies and case series to be a useful emerging treatment, especially when self-care is a priority, in the management of dermatological conditions resulting in:

     

     Varicose eczema

     Epidermolysis bullosa

     Chronic wounds in dermatological patients

     Dry, scaly and flaky skin conditions

     Hyperkeratosis associated with venous disease

     Secondary skin changes associated with chronic oedema and lymphoedema

     Actinic keratosis

     Prior to photodynamic therapy

     Acne vulgaris

     

    The 18 million special monofilament fibres which have angled tips to reach uneven areas of the skin or wound bed are able to remove unwanted tissue, materials and skin, allowing other concurrent treatment to reach their target area without the barriers imposed by for e.g. devitilised tissue, dry, scaly and flaky skin and other debris and materials. This technology has received positive NICE guidance¹⁷ for use in acute and chronic wounds. MFDT is very soft, comfortable and gentle on patients. It is safe and easy to use and can also be used by patients for self-care.

     

    Conclusion:

    A review of the supporting evidence clearly supports the continued research and interest in MFDT related to dermatological conditions.

  3. Poster

    Wound related pain during debridement using monofilament debridement pads

    Poster presented at EWMA 2018 09.05.2018

    Aim:

    Debridement is key to management of both slough and biofilm, and a number of methods are available to achieve this including surgical and mechanical debridement. Recent developments have led to new products indicated for debridement of wounds, including a unique sterile pad consisting of monofilament fibres. The purpose of this project was to examine wound related pain during mechanical debridement using monofilament debridement pad (WDP).

     

    Method:

    This is a case series of 10 patients with acute or chronic wounds that had slough required debridement. All wounds were debridement weekly for four weeks. Pain at baseline and during the debridement procedure (procedural pain) was evaluated using a verbal analogue scale (VAS) on which 0 was no pain and 10 was the worst pain imaginable.

     

    Results / Discussion:

    The wounds treated (number) were surgical wounds (3); pressure injury (3); venous leg ulcer (2); diabetic foot ulcer (1); trauma wound (1). The mean surface area covered by slough in the 10 wounds at week 0 was 79%. In every case the surface area of the wound covered by slough at week 0 reduced by week 4 to a mean of 8%. The average pain score at baseline was 6 in comparison to the mean pain of 7 during the debridement procedure using monofilament pads.

     

    Conclusion:

    WDP provides an effective solution to the goal of removing loose slough, deeply cleaning wounds and removing exudate. WDP does not induce high levels of procedural pain and any such pain subsided once debridement was complete.

    Products Debrisoft Pad
  4. Poster

    Assessment of The Cleansing Capacity of a Monofilament Debrider Compared to Conventional Cosmetic Pads in an Acne Sebum Model

    Poster presented at EWMA 2018 09.05.2018

    Aim:

    Acne is a long-term, multiform skin disease that is characterized by increased sebum production (seborrhea) and comedo formation (blackheads or whiteheads). However, over time, inflammatory papules, pustules, and nodules may develop. For acne treatment, several options are available with the aim to normalize skin cell shedding and sebum production in the pore to prevent blockage and kill bacteria (such as P. acnes) to reduce inflammation. Hence, frequent cleansing of the skin is necessary without adding to the skin irritation. The recently introduced monofilament debrider may present a beneficial option, removing the protein-rich crusts, effectively, fast, and pain-free.

     

    Method:

    The sebum model consists of glass plates coated with an oil-red-stained layer of artificial sebum. The monofilament debrider* and conventional cosmetic pads**,***,**** were used to clean the glass plates under standardized conditions (p=0.067N/cm2, v=1.6cm/s). Images were obtained before and after treatment and processed using ImageJ 1.45m.

     

    Results / Discussion:

    The monofilament debrider* exhibited a significantly higher cleansingefficacy compared to the cosmetic pads in vitro. While the monofilament debrider* was able to remove the artificial sebum almost completely (98.9% cleansed area), significantly lower efficiencies were noted for the conventional cosmetic pad**(46.9%), the conventional cosmetic pad***(76.2%), and the conventional cosmetic pad**** (54.7%).

     

    Conclusion:

    Treatment of acne vulgaris requires an efficient skin cleansing to remove surplus sebum and prevent pore blockage. However, added irritation of the skin should be avoided. Using a model with artificial sebum, it could be shown that the cleansing capacity of the new monofilament debrider is significantly higher compared to commercially available cosmetic pads.

    Products Debrisoft Pad
  5. 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.

    Further versions
  6. Poster

    A super absorbent dressing* for management of patients with moderate-to-highly exuding wounds - a clinical study

    Poster presented at EWMA 2018 09.05.2018 Krakow, Poland

    Aim:

    A polyacrylate containing super absorbent dressing* can be used for patients with moderate-to-high exuding wounds. The study evaluated the performance of the superabsorbent dressing* in daily clinical practice.

     

    Method:

    German physicians from different specialisms participated: 23 general medicine, 13 surgery, 14 internal medicine and 3 other departments. Both the dressing and questionnaire were supplied by the sponsor. After dressing use the physicians scored on handling properties, absorbent capacity, user satisfaction and patient comfort. The super absorbent dressing* was used for at least 3 dressing changes in 171 patients (86 (50.3%) men, 78 (45.6%) women, 7 (4.1%) not scored).

     

    Results / Discussion:

    The centers used their current protocol. The patients had pressure ulcers (8 (4.7%), venous leg ulcers (113 (66%), diabetic foot ulcers (8 (4.7%), post-surgery (14 (8.2) and infected wounds (8 (4.7%). Dressing application was rated easy by 168 (95%) of the clinicians and the dressing demonstrated a good absorbent capacity as noted by 167 (98%) of the respondents. The dressing was rated easy to remove (168 (98.3%) and did not soil clothing according to 165 (97%) of the respondents. N=157 (94%) patients reported to be satisfied with the performance of the dressing as well as 166 (99%) of the physicians, who additionally reported (156 (94.6%) the dressing to be safe and reliable for the task at hand.

     

    Conclusion:

    The study design allowed for collecting data on the dressing in daily clinical practice. The evaluated dressing* was easy to use, comfortable and reliable for patients with moderate-to-high exuding wounds.

    Products Vliwasorb Pro
  7. Poster

    PROVIDING COMPRESSION OPTIONS: THE KEY TO BETTER COMPLIANCE AND CONCORDANCE FOR PATIENTS LIVING WITH CHRONIC EDEMA

    Poster presented at EWMA 2018 09.05.2018 Krakow, Poland

    Aim:

    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.

     

    Method:

    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.

     

    Conclusion:

    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 TCS
  8. Poster

    A NEW PHMB-CONTAINING PU FOAM* EXERTS ANTIBACTERIAL EFFECTS ON PSEUDOMONAS AERUGINOSA AND A STAPHYLOCOCCUS AUREUS BIOFILM

    Poster presented at EWMA 2018 09.05.2018 Krakow, Poland

    Aim:

    Chronic wounds are often colonized by different microorganisms, the most prominent being Staphylococcus aureus and Pseudomonas aeruginosa. PHMB-containing dressings have been shown to effectively inhibit bacterial progeny. However, bacteria do not act alone and the concept of biofilm formation and presence is now widely accepted. Therefore, current research targets antibiofilm strategies to restore an optimal wound-healing environment. A combined treatment approach involving debridement and the addition of antibacterial agents may then provide the highest success rates. Here, the efficacy of the new PHMB-containing PU foam* against a Staphylococcus aureus biofilm was evaluated in vitro. Moreover, antibacterial activity was evaluated in a direct contact method against Staphylococcus aureus and Pseusomonas aeruginosa.

     

    Method:

    Antibacterial activity against S. aureus and 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:

    The new PHMB-containing PU foam* displayed complete inhibition of S.aureus and P.aeruginosa in the direct contact test, rated as strong antibacterial activity according to JISL1902:2002 (log-reduction>3). Treatment of S.aureus biofilm with the new PHMBcontaining PU foam* efficiently reduced biomass and significantly less viable bacteria were observed.

     

    Conclusion:

    It was found that the new PHMB-containing PU foam* exhibits a strong antibacterial activity against prominent microorganisms in chronic wounds. Moreover, it could be shown to reduce biofilm. Hence, it can be expected to exert beneficial effects in stagnating wounds and promote healing.

    Further versions
  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.

    Further versions
    Further languages
  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