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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

      Simple solution to reduce edema before Medical Elastic Hosiery

      Poster presented at EWMA 2018 09.05.2018 Krakow, Poland

      Aim:

      Although hosiery is the golden standard in the maintenance phase for treating lymphedema or venous leg ulcers, clinical challenges exist where hosiery may not be suitable due to unresolved edema or practical application issues. In this study a practical solution for this group of patients was implemented using a Leg Ulcer Hosiery Treatment System.*

       

      Method:

      9 patients, 5 males, 4 females aged between 45 – 87 years old. 7/9 edema, I erysipelas and I DVT. Previous treatment: 6/7 no treatment, 2 Tubigrip, 1 ill-fitting hosiery Referrals from the General Practitioner or Medical Specialists to the bandager Medical Stockings measurement. In all cases edema persisted and an alternative solutions was chosen using the new system for 4 – 6 weeks for treatment of the edema.

       

      Results / Discussion:

      After evaluation, there was an immediate effect reduction in edema, from 6 to 14%. Comfort and Donning was good to very good. Doffing was average to good. Patients were able to wear their own shoes, stay active and in some cases, continue working. They were measured for follow on Medical Stockings. The system was simple, effective, promoted self-care and was available off the shelf. Costs of bandager and community nurse time were reduced.

       

      Conclusion:

      Simple solutions such as the 2 layer Leg Ulcer System can help patients and caregivers for the treatment of edema with or without a wound. Benefits are self-management and cost efficiency instead of 2 – 3 x week bandaging. All patients could fit into their own shoes, and this motivates mobility.

      Products Actico UlcerSys
    2. 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
    3. 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.

    4. Poster

      MEASURING THE IMPACT OF EDEMA MANAGEMENT - MORE THAN JUST A VOLUME REDUCTION

      Poster presented at EWMA 2018 09.05.2018 Krakow, Poland

      Aim:

      Chronic edema of the lower leg has a negative impact on functional performance. Chronic edema impairs foot wear use and normal gait patterns, impairs calf muscle pump and most importantly limits the patient’s ability to interact with his/her environment. This negative spiral of progressive edema and progressive decline in functional status can be

      reversed simply by addressing the edema.

       

      Method:

      Observational study performed at 2 separate outpatient edema management clinics. Eight patients were referred for lower extremity edema management to a physical therapist. Objective data measured including limb volume, ankle range of motion (ROM), functional activity status utilizing the Timed Up and Go (TUG) and the 4 meter walk test (4MWT), and assessment of quality of life (QOL) via the Lymphoedema QOL tool (LYMQOLLeg). Measurements were taken at initial evaluation, upon completion of treatment, and 2 weeks post treatment. Patients received compression therapies* and instruction in home exercise program only. Gait training was performed during the sessions for safety with assistive device when appropriate.

       

      Results / Discussion:

      Reduction of swelling had a direct positive impact on all outcomes measured. LYMQOL-Leg scores and functional performance scores (TUG and 4MWT) improved by 15% and 0.1m/sec respectively. Functional performance continued to improve after active therapy had been discontinued with further increased TUG scores at the 2-week follow-up assessment. The reduced edema allowed for normal footwear use, normalized gait patterns which increased mobility and enhanced QOL.

       

      Conclusion:

      Management of lower extremity edema has a positive impact on both patient’s functional status and QOL.

    5. Poster

      First experiences in use of a monofilament fibre pad* in treatment of patients suffering from retentive and cystic manifestation of acne*

      Poster presented at EWMA 2018 09.05.2018 Krakow, Poland

      Introduction:

      Acne vulgaris is a common problem in youth and early adolescence and it is characterized by areas of skin with increased oil-sebum secretion (seborrhea) and formation of comedones, papules, pustules, as well as nodules [1,2]. Frequently, scarring is the result of the inflammatory processes within the dermis. Acne vulgaris traces back to an enlargement of sebaceous glands and an enhancement in sebum production linked to an increased production of sexual hormones (e.g. androgens). Acne then develops when sebaceous glands becoming clogged with sebum (microcomedo). These microcomedos are able to enlarge to form an open comedo (so called “blackhead” due to the fact that oxidation of sebaceous material at the porus is changing colour) or closed comedo (also called “whitehead” and often associated to cystic sebum retention). Typically, under such conditions naturally occurring bacteria can cause inflammation, leading to inflammatory lesions (papules, infected pustules, or nodules) in the dermis around the comedone [3]. For management of acne, any different treatment recommendations exist, including different pharmacologic and non-pharmacologic opportunities to remove the sebaceous clogging [3]. They are aimed to normalize shedding and sebum production to prevent blockage of pores. Additionally, reduction of microbial bioburden, exertion of antiinflammatory effects, and manipulation of hormone production are in therapeutic focus. Additionally, a strict regime for skin lavation is recommendable to remove surplus sebum and prevent clogging. Thus, however, can be supported by effective mechanical removal of excessive sebum formation. This could be amended by using a monofilament fibre debridement pad, which has been designed to provide fast, effective mechanical removal of proteinaceous crusts that is pain- and trauma free. First in-vitro testing [4] was able to demonstrate efficacy in cleaning by using the debridement model with artificial sebum.

       

      Methods:

      During a time period of four months, a semi-systematic case series was performed in young people suffering from retentive manifestation of acne vulgaris to collect practical aspects of the use of the monofilament fibre pad in combination with typical dosage forms of polyhexanide (PHMB) and Sodium-hypochlorite based solutions (medical devices) in order to achieve first practical experiences in combined use. This small case series was focused on comfort aspects, acceptance and clinical benefit in use. Application has taken place periodically thereafter as necessary daily up to twice weekly.

       

      Results / Discussion:

      Results achieved (n=7): “Pad handling” excellent in six and acceptable in one case. After single use, reduction of sebum retention was excellent in three and acceptable in four cases. Results have been improved to six “excellent” and one

      “acceptable” after repeated use. “Treatment comfort” and “compatibility” achieved excellent in all cases. The overall acceptance and user satisfaction were encouragingly positive. Application was “very comfortable” and “easy in use” for all cases. Cleaning efficacy was very satisfactory and seemed to be superior compared to cosmetic pads. Combination with different cleaning solutions was fully compatible.

       

      Conclusion:

      First clinical experiences in use of the monofilament fibre pads were exceedingly satisfactory. Removal of sebum retention was efficient and combination with different cleaning solutions did not show any signs of incompatibility. Hence, a systematic approach to collect clinical data would be very much appreciated.

      Products Debrisoft Pad
      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

      Guidelines, assessment, appropriate referrals and treatment can improve patient outcome

      Poster presented at EWMA 2018 09.05.2018 Krakow, Poland
    8. Poster

      The real value of mechanical debridement in complex wounds - a clinical study

      Poster presented at EWMA 2018 09.05.2018 Krakow, Poland

      Aim:

      The study compared clinical efficacy and cost of autolitic, enzymatic and mechanical debridement using a monofillament pad* and a pad with a handle.

       

      Method:

      A monofilament debrider was proposed for its efficacy, safety, tolerability and ease of use. Eighty community patients with complex wounds containing sloughy tissue were allocated to the treatment groups at random, after they consented. They were followed for 15 days. At baseline medical history, wound characteristics and privious treatment was recorded. During visits wound condition, patient reported pain during debridement, time required for the procedure and product handling, were scored. Costs calculation took into account clinical efficacy, time to debridement, number of home visits, nursing costs, costs

      per product used.

       

      Results / Discussion:

      Debridement was effective and comfortable using all evaluated methods (on a 5-point Likert scale, the 2 monofilament products scored a mean of 4,9 and 4,8, enzymatic sored a mean of 4,6 and autolytic debridement a mean of 3,6). The total costs for debridement using the monofilament pad* and product with handle was Euro 58,67 and Euro 72,47 respectively. For enzymatic debridement the total costs were Euro 213,35 and for autolytic debridement Euro 98,67. Cost was significantly lower in the monofilament group due to a reduction in debridement time, number of visits and nursing time.

       

      Conclusion:

      The addition of the monofilament products to our debridement portfolio use for wound management in the community represents an added value in the treatment available for patients with complex wounds with appropriate use of tight resources.

      Products Debrisoft Pad
    9. 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
    10. 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