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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

      Compression hosiery for venous disorders and oedema: a question of balance

      British journal of community nursing 2020 25(9) 2632

      Compression therapy for venous and lymphatic conditions may be delivered via a range of treatment modalities using many different technologies, depending on the patient's condition and needs. Clinical decision-making relies on accurate assessment of the patient, their presenting and underlying clinical condition, skill and training of the applier and the available resources. However, changes in the patient's condition or lifestyle may necessitate re-evaluation of the treatment pathway. Generally, compression bandages and Velcro wraps are used in the intensive acute phase of treatment, with self-management using compression hosiery or wraps being used for long-term maintenance to prevent recurrence. Although guidelines recommend the highest class of compression hosiery for maximum effectiveness, clinical evidence shows practical challenges associated with application and tolerance of higher pressures and stiffness. An audit of a new type of compression garment was conducted, and it showed that incorporating stiffness into circular knitted hosiery helped overcome some of these challenges with improvements in limb size, skin softening and wound size. Additionally, self-management was facilitated by the ease of donning and doffing.

      PMID 32886551
      Downloads Citation (RIS)
    2. Journal article

      Compression Therapy Is Not Contraindicated in Diabetic Patients with Venous or Mixed Leg Ulcer

      Journal of clinical medicine 2020 9(11)

      The aim of this study was to investigate if compression therapy (CT) can be safely applied in diabetic patients with Venous Leg Ulcers (VLU), even when a moderate arterial impairment (defined by an Ankle-Brachial Pressure Index 0.5-0.8) occurs as in mixed leg ulcers (MLU).

      MATERIALS AND METHODS

      in one of our previous publications we compared the outcomes of two groups of patients with recalcitrant leg ulcers. Seventy-one patients were affected by mixed venous and arterial impairment and 109 by isolated venous disease. Both groups were treated by tailored inelastic CT (with compression pressure 40 mm Hg in patients with MLU and >60 mm Hg in patients with VLU) and ultrasound guided foam sclerotherapy (UGFS) of the superficial incompetent veins with the reflux directed to the ulcer bed. In the present sub analysis of the same patients we compared the healing time of 107 non-diabetic patients (NDP), 69 with VLU and 38 with MLU) with the healing time of 73 diabetic patients (DP), 40 with VLU and 33 with MLU.

      RESULTS

      Twenty-five patients were lost at follow up. The results refer to 155 patients who completed the treatment protocol. In the VLU group median healing time was 25 weeks for NDP and 28 weeks in DP (p = 0.09). In the MLU group median healing time was 27 weeks for NDP and 29 weeks for DP (p = -0.19).

      CONCLUSIONS

      when providing leg ulcer treatment by means of tailored compression regimen and foam sclerotherapy for superficial venous refluxes, diabetes has only a minor or no effect on the healing time of recalcitrant VLU or MLU.

      PMID 33227909
      Downloads Citation (RIS)
    3. Poster

      Mechanical debridement of leg ulcers and the surrounding skin using a monofilament fibre debridement pad designed for larger wounds and surface areas

      Poster presented at Wounds UK 2019 04.11.2019 Harrogate, UK

      Introduction

      In the management of leg ulcers and hyperkeratosis of the surrounding skin, it is not uncommon for them to affect very large areas of the leg. The large size also leads to an increase in the level of exudate and the amount of devitalised tissue. As a result, a larger amount of material is needed to loosen and remove the devitalised tissue than is the case with smaller wounds. The size of the area of the wound that can be treated at the same time is limited by size of your debridement device. An already well established and proven [1] monofilament fibre debridement pad* has been increased in size to tackle this issues. The handling has been improved [2] by adding a mitten on the back side. To evaluate the performance of this debridement pad optimised for larger wounds and the surrounding skin, a small case series was performed.

       

      Method

      For the case series leg ulcers of various origins that needed debridement were treated once or over a longer period of time with the larger pad when indicated. The treatment was documented both photographically and in writing. The patients gave their written consent to the preparation of the case studies and the use of the image material.

       

      Results

      Case 1:

      A 64 year old female patient with mixed aitiology leg ulcers with a history of reoccurrence since 2000 and has been in our treatment since 2015. Over the least 5 years she has ulcers spreading to cover the entire gaiter area of both lower legs. The wounds were colonised regularly with bacteria/biofilm. The patient suffers from pain of 8-9 on the VAS scale especially at night but the debridement was well tolerated and biofilm removal effective.

       

      Case 2:

      A 83 year old female patient suffering from venous leg ulcers since August 2017 and has been in our treatment since April 2019. There were many small superficial ulcers and erosions with hyperkeratosis on the whole lower leg and a red inflammation of the wound surrounding area due to infection. After a few uses of the debridement pad most of the ulcers and erosion were healed.

       

      Case 3:

      A 70 year old male patient with venous leg ulcer on his left lower leg which has been present for 4 month and in our treatment since April 2019. Several ulcers had firmly adhering slough and necrotic tissue. After the debridement more granulation tissue became visible.

       

      Case 4:

      A 64 year old patient suffering from obesity associated leg ulcers. The ulcer on the left lower leg occurred in November 2017 as a result of a trauma from a fall and was extremely painful making wound dressing difficult. The debridement with the larger pad was well tolerated and efficient. Some additional surgical debridement was necessary.

       

      Case 5:

      A 70 year old male patient has been treated since July 2017 due to ulcers spreading to cover the entire gaiter area of both lower legs. The ulcers had almost healed leaving the wound surrounding skin covered with hyperkeratosis. Debridement with the larger pad was pain-free for the patient with some superficial bleeding because large, adhered pieces of the hyperkeratosis have been removed.

       

      Discussion

      Due to the increased size of the monofilament fibre debridement pad, large areas could be treated very efficiently. Most of the time one pad was sufficient, even for ulcers spreading to cover the entire gaiter area. For the treatment of smaller wounds or areas, smaller versions of the device are available and might be more efficient. The mitten on the back of the pad enables the user to easily use the whole surface of the debridement pad at the same time. As a result, a much larger area could be treated quicker than it would have been possible with a smaller device. In addition, the enlargement of the device is accompanied by an increase in the absorption capacity for exudate, slough and debris.

       

      Conclusion

      The larger monofilament fibre debridement pad is a useful addition to the existing smaller versions. Especially useful and effective for bigger wounds and areas.

      Products Debrisoft Pad
      Further versions
    4. Poster

      EVOLUTION OF A NATIONALLY ADOPTED VENOUS LEG ULCER BEST PRACTICE TREATMENT PATHWAY TO REFLECT NEW EVIDENCE

      Poster presented at EWMA 2019 05.06.2019 Gothenburg, Sweden

      Aim:

      A National Best Practice Statement for the holistic management of venous leg ulcers¹ presents a treatment pathway, originally developed by Atkin and Tickle². The aim was to revise this treatment pathway to reflect new evidence³.

       

      Method:

      The treatment pathway was originally developed to reflect published RCT evidence for venous intervention reducing episodes of reoccurrence (ESCHAR trial)⁴ and with leg ulcer hosiery kits as first line as a result of the publication of the VenUS lV study⁵. The treatment pathway has been used since 2016 and needed further updating to reflect the recent evidence investigating the impact of early venous ablation in patients with venous leg ulcers (EVRA)⁶.

       

      Results / Discussion:

      In a group of 34 patients with leg ulceration the implementation of this pathway into everyday clinical practice has been shown after 3 months to deliver a number of benefits including increased healing rates, improved documentation and a reduction of nursing visits⁷;

       From 0% to 76% having their leg ulcer diagnosis recorded

       From 34% to 76% having their ABPI recorded

       From 13% to 83% use of compression therapy

       From 7% to 56% healing or signs of healing

       43% reduction in nursing visits

       

      Conclusion:

      It is vital to ensure that current research evidence is adopted within frontline services as soon as possible. Formalised evidence-based pathways provide a practical treatment guide and can help reduce unwanted variations, as standardising clinical processes through the use of a pathway is known to optimise the quality of treatments and improve patient satisfaction.

    5. Poster

      Achieving healing in a young adult with a venous leg ulcer using a biofilm pathway and short stretch bandaging

      Poster presented at Wound Care Today 2019 27.02.2019 Milton Keynes, UK

      Introduction

      Liam is a 26 year old man who suffered a post trauma DVT when just 18 years old. He has Warfarin therapy and has a history of venous leg ulceration for 8 years. Because of the damage to his primary, deep veins he had developed a collateral venous circulation.

      Liam describes having a leg ulcer at a young age as “life changing”. It stopped him playing sport and swimming and it changed how he interacting with friends. Because of his damaged circulation and medication he lived with the constant fear that his leg was going to deteriorate or bleed. Despite this, Liam continued to work full time and support his family.

       

      Method

      In the summer of 2018, Liam’s nurse changes his treatment from a combination long-stretch cohesive bandage system, to a cohesive short stretch bandage system. She also implemented a Monofilament fibre biofilm based treatment regime to expedite wound bed preparation and disruption of the biofilm (Morris et al, 2016).

       

      Results

      There was a dramatic reduction in leg oedema and improvement in leg shape almost immediately the new bandage system was started. Things continued to improve over the following months. Liam reported that the cohesive short stretch bandage system made “his leg feels much more comfortable with less ridging and less slippage”. His leg shape was much better, and it was easier to wear socks and shoes. Liam said that nobody noticed he had a bandage on.

      In December 2018, after 8 years of ulceration, Liam’s venous leg ulcer healed.

       

      Conclusion

      This case study demonstrates how learning and implementing new knowledge, technology and skills can translate into improved patient outcomes. By sharing Liam’s story we can really understand the devastating effect a leg ulcer can have, especially on a teenager and young adult.

      Liam now has a bespoke plan for the prevention of future venous leg ulcers which will include higher compression during working periods when he will be on his feet for long periods. This is achieved by using short stretch wrap systems to encourage continued self-care and ownership of his long term condition.

    6. Journal article

      Bedeutung des adäquaten Drucks in der Kompressionstherapie: Basis der erfolgreichen Behandlung

      Der Hautarzt; Zeitschrift fur Dermatologie, Venerologie, und verwandte Gebiete 2019 70(9) 707714

      BACKGROUND

      The pressure exerted by a compression device on a part of the body corresponds to the dosage of the compression therapy. Therefore, the pressure course under compression materials should be investigated in different clinical situations.

       

      MATERIAL AND METHODS

      Pressure measurements were carried out under different compression materials in lying, standing and walking positions within the framework of training, self-experimentation and in patients with venous leg ulcers.

       

      RESULTS

      The results showed that the pressure varied considerably depending on the material used, the firmness of application, the local configuration (body position) and the time interval between applications. A loss of pressure occurred under each compression therapy, especially under inelastic short-stretch material, mainly due to movement and edema reduction. This pressure loss is decisive for the timing of dressing changes and a reason for the good tolerance of high-pressure levels in mobile patients.

       

      CONCLUSION

      Low pressures are particularly suitable for edema reduction. Hemodynamic effects require higher pressures (60-80 mmHg). For this purpose, inelastic materials are preferred which enable lower pressures when lying down (40-60 mmHg). As compression bandages are too loosely applied by many users, pressure indicators on bandages or adaptive bandages with templates are helpful to apply the material with the correct pressure. As a consequence of these findings it is postulated that, at least in studies comparing different compression media, pressure measurements should be carried out in the future, whereby the measuring point and body position should be documented.

      Products Mollelast, Haftan
      PMID 31165190
      Downloads Citation (RIS)
    7. Journal article

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

      Journal of wound care 2019 28(7) 429435

      OBJECTIVE

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

       

      METHODS

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

       

      RESULTS

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

       

      CONCLUSION

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

      PMID 31295092
      Downloads Citation (RIS)
    8. Journal article

      ReadyWrap®: case studies in practice

      British journal of community nursing 2019 24 2431

      The cost that chronic wound care imposes on both patients and health services worldwide is well recognised. Most patients with venous leg ulcers require compression therapy over the long term, for both treatment as well as to prevent recurrence of these wounds. Caring for patients with chronic wounds makes up a large part of the workload for district and community nurses, and encouraging self-management among patients is a worthwhile effort to limit the costs and resources directed for this purpose. The present article describes the practical use of the ReadyWrap range of compression garments, which are available in various different styles, and aid patients, their families and carers in the self-management of venous leg ulcers. These products are designed with their long-term use in mind, and, as described in the case studies in this article, patients show good concordance to compression therapy involving ReadyWrap.

      PMID 31604036
      Downloads Citation (RIS)
    9. 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.

    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

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