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    1. Poster

      Multinational observational study on the performance, handling and safety of a new alginate wound dressing

      Poster presented at EWMA 2022 23.05.2022 Paris, France

      Aim:

      Alginate dressings play an important role in modern wound care. Areas of application include exudate management, autolytic debridement and hemostasis. Users of the alginate dressings have high demands on performance, handling and safety. In order to meet these requirements, a new alginate wound dressing* was developed from a mixture of 80% alginate and 20% viscose. In the study presented, the wound dressing was tested for the properties described.

      Method:

      An observational study was carried out in clinical as well as outpatient settings at study centers in Germany, Austria and Poland. The users were asked to treat up to 8 patients with the new alginate according to the instructions for use. All patients were adults and suffered from highly exuding wounds which were either pressure injuries, arterial/venous ulcers, diabetic ulcers or postoperative wounds.

      Results / Discussion:

      The performance, measured in the parameters of time required for application and adaptation to the wound bed in dry and gelled conditions, was rated on average by users as good or very good/excellent on a 6-point Likert scale. More than 90% of the users stated that they could achieve their treatment goals, in particular exudate management, autolytic debridement and hemostasis. All handling parameters were also rated as good or very good on average. The alginate caused almost no maceration of the wound edge and was usually removed very easily in one piece.

      Conclusion:

      The alginate dressing met the performance, handling and safety requirements and was very positively received by users.

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    2. Poster

      Application of an antimicrobial cellulose wound dressing on infected lower leg ulcers: 2 case studies

      Poster presented at WoundsUK 2021 08.11.2021 Harrogate, UK

      Introduction:

      The treatment of infected chronic wounds is a challenge in everyday clinical practice. In the treatment of these wounds polyhexanide (PHMB) is the antiseptic of choice [1]. Patients with difficult personal backgrounds further complicate the successful treatment of these wounds. Two case studies of infected chronic lower leg ulcers are presented. The treatment was carried out with an antimicrobial wound dressing made of cellulose containing PHMB*.

       

      Method:

      Patient 1: A 27-year-old male patient from the UK with an infected venous leg ulcer on the right lower leg that had been present for 11 months (size: 315 cm², depth: 0.1 cm). Moderate exudation, odour and pain of VAS=7 present. A deep vein thrombosis has recently occurred. In addition, the patient suffers from drug addiction (intravenous), alcohol addiction and mental disorder. The patient was previously treated with a hydrogel-impregnated antimicrobial wound pad and a medical-grade honey dressing. The new treatment consisted of cleaning with a monofilament fibre debridement pad**, the antimicrobial cellulose dressing, a sterile absorbent compress and a tubular dressing as a secondary dressing.

       

      Patient 2: An 80-year-old male patient from Germany with a mixed gaiter ulcer on the right lower leg (size: 450 cm², depth: 1 cm). Before the patient was admitted for treatment, he had already had several inpatient hospital stays. Therapy with a split-thickness skin graft was unsuccessful. The wound is infected with multidrug resistant gram-negative bacteria (MDRGN bacteria). The patient has had several antibiosis. The patient showed a constant incompliance with regard to the therapy attempts. Finally, a healing attempt with medicinal clay took place on the advice of his alternative (non-medical) practitioner. The patient was taken over with a massive infection, severe exudation and odour formation. Wound and lower leg pain correspondent to 8 on the Visual Analogue Scale (VAS). The entire lower leg was oedematous and papular indurations were present in the area of the forefoot. The wound was covered with biofilm and partially with fibrin. The wound edges and the surrounding skin were inflamed. Individual lesions were present. The patient's hygiene was poor. The weekly treatment was as follows: The wound was first cleaned with a wound irrigation solution containing sodium hypochlorite and a monofilament fibre debridement pad. The primary wound dressing was the cellulose dressing with PHMB. A highly absorbent wound compress*** and a superabsorbent wound dressing‡ served as a secondary dressing. In addition, the edema was treated with a compression bandage‡‡.

       

      Results:

      Patient 1: After 14 days and 5 dressing changes, the wound pain had decreased significantly (VAS = 1). The wound odour was gone. While the beginning granulation of the previously stagnant wound was particularly positive from the point of view of the user, the patient was particularly pleased that the wound odour had disappeared and that wound exudate no longer penetrated the dressing. The treatment was continued accordingly.

       

      Patient 2: After 3 weeks, not only had the wound pain (VAS = 6-7) decreased, but the wound odour and signs of infection had disappeared. Granulation tissue was visible. After 4 weeks, the wound pain (VAS = 5-6) decreased even more. Although the patient acknowledged the success of the therapy and the reduction in pain, he stopped the treatment on the advice of his alternative practitioner.

       

      Discussion:

      Although the two cases involved patients with longstanding chronic wounds and difficult personal backgrounds, the users were able to heal the wound within a short time with the help of the antimicrobial cellulose wound dressing and adequate modern wound care. For the two users, the rapid treatment success, in the form of the beginning healing, was gratifying. For the patients, it was primarily the pain reduction and the decrease in wound odour that were particularly well received. This is not surprising, as these two factors play a major role in the patient's quality of life.

       

      Conclusion:

      The antimicrobial wound dressing proved to be a suitable for the treatment of infected chronic wounds.

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    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 WUWHS 2020 13.09.2020 Abu Dhabi, UAE

      Background and Aims

      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. To evaluate the performance of this debridement pad optimised for larger wounds and the surrounding skin, a small case series was performed.

       

      Methods

      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.

       

      Results

      Five patients between the ages of 64 and 83 were treated. All of them suffered from chronic ulcers covering a big area on their legs. At least some of the wounds were colonised with bacteria/biofilm. Two patients were suffering from hyperkeratosis, too. The debridement with the debridement pad was well tolerated by the patients. Biofilm as well as devitalised tissue were removed effectively. All wounds were healed or becoming better.

       

      Conclusions

      Most of the time one pad was sufficient, even for ulcers spreading to cover the entire gaiter area. A much larger area could be treated efficiently and 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.

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    4. Journal article

      Rapid debridement with monofilament fibre debridement technology: Clinical outcomes and practitioner satisfaction

      Journal of wound care 2019 28(8) 534541

      OBJECTIVE

      To determine the clinical effect and consequential levels of health professionals and patient satisfaction with the results of debridement episodes of wounds with visible slough and/or scaly skin using monofilament fibre debridement technology.

       

      METHODS

      This was a non-comparative, open label evaluation conducted in static/non-healing acute and chronic wounds with visible slough and/or scaly skin that required debridement. Monofilament fibre debridement technology was applied in 1-2 sequential treatment episodes during normal clinical practice which followed local practice, guidelines or formularies. Following the clinical phase of the evaluation, health professionals were invited to complete an online survey of the clinical outcomes and their satisfaction with them.

       

      RESULTS

      Survey questions were answered by 1129 health professionals. Wounds managed using the monofilament fibre debridement technology during this evaluation included leg ulcers (63%), pressure ulcers (10%), dehisced surgical wounds (3%), diabetic foot ulcers (8%) and other wounds (13%). 'Other' wound types included acute dirty wounds, burns, cellulitis, psoriasis, diabetic amputation wounds, dry flaky skin, moisture wounds, trauma, varicose eczema. Of the wounds, 12% were reported as non-static. There was visible change in the wound and/or skin after first use of the monofilament fibre debridement technology in a high proportion of all wound types, and a further increase in the proportion of wounds with visible change after the second use. The visible difference was significant for both static and non-static wounds. User and patient satisfaction with all clinical outcomes were high, whether or not the user and patient had previous experience of monofilament fibre debridement technology.

       

      CONCLUSION

      Monofilament fibre debridement technology provides rapid, visible and effective debridement of slough and scaly skin after one application and further visible improvement after two applications in static and non-static wounds. Health professionals and patients report high levels of satisfaction with outcomes following application of the monofilament fibre debridement technology.

      Products Debrisoft Pad
      PMID 31393801
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    5. 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.

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    6. Journal article

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

      Journal of Wound Care 2019 28(9) 608622

      Objective:

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

       

      Methods:

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

       

      Results:

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

       

      Conclusion:

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

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      PMID 31513491
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    7. Journal article

      A purpose-designed monofilament-fibre pad for debridement of hard-to-reach wounds: Experience in clinical practice

      Journal of Wound Care 2018 27(7) 421425

      Objective:

      Effective and comfortable debridement is an important part of managing complex wounds. This user test evaluated a monofilament-fibre pad (with handle) (Debrisoft Lolly, Lohmann & Rauscher GmbH & Co. KG) in the debridement of various hard-to-reach wounds.

       

      Method:

      The multicentre, international user test was performed by experienced physicians and nurses in Germany and the UK, who used the monofilament-fibre pad in their clinical practice. After debridement, using the monofilament-fibre pad, the clinicians completed an evaluation questionnaire. The assessment comprised of performance, usability, tolerability, safety and suitability of the device for debridement, comparing it with standard methods used in the clinicians' centres.

       

      Results:

      A total of 23 clinicians in 20 centres each treated between six and 10 patients with the monofilament-fibre pad (a total of 155 wounds of different aetiologies). Most participating patients had deep wounds (n=63 (41%)) or cavity (n=31 (20%)) wounds. When compared with the standard debridement method used at the centres, the tested device was scored as ‘easier’ or ‘equally easy’ to use in all cases. When comparing the standard debridement procedure with the monofilament-fibre pad, debridement duration was reported as equal to or shorter than the standard method in 90% of cases when using the monofilament-fibre pad. Debridement efficacy was scored by the clinician as ‘better’ or ‘equal’ for the monofilament-fibre pad in 67% of cases. Overall, patients reported that the study device was comfortable.

       

      Conclusion:

      The monofilament-fibre pad effectively, easily and safely removed slough and debris from wounds of various aetiologies and was effective in wounds of different shapes, such as in cavity wounds and those in hard-to-reach locations.

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    8. Journal article

      Improving the monofilament-fibre pad to debride wounds

      Wounds UK 2018 14(4) 100105

      Objective:

      In clinical studies, mechanical wound cleansing and debridement using a monofilament fibre product has been shown to be effective, and pain and traumafree.

       

      Methods:

      Two new monofilament fibre devices, both refinements of the existing Debrisoft pad, were created. The first added a pocket grip, and the second increased the size to 13 × 20 cm and retained the pocket grip. They were assessed in two acceptance evaluations.

       

      Results:

      The pads were assessed by 65 clinicians, split into two evaluations. The two new products with pocket grip was easy to handle, with a very good grip and hold. They fitted hands well, could be handled safely and were controlled and intuitive.

       

      Conclusions:

      The first product with the hand pocket met the design criteria (flexibility and stretchability of the pocket, softness and grip/hold, and easy handling). The larger pad met the design criteria regarding the fit of the pocket, safe and controlled use, and intuitive handling.

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    9. Poster

      The Debrisoft® difference challenge: Subgroup analysis of a survey on the debridement of biofilm-infected wounds

      Presentation at AIUC 2017 04.10.2017 Turin, Italy

      INTRUDUCTION

      Biofilm, one of the main issues that prevent a chronic wound from healing, is a combination of bacterial and fungal cells, embedded in an extracellular matrix composed of hydrated polymers and debris [1]. Antibiotics are of limited use in biofilm-infected wounds, because biofilm can be polymicrobial [2] and the cells are many times more resistant to it [3]. Therefore the biofilm has to be physically disrupted and removed by debridement. This survey was designed to investigate on a 2 week wound management pathway, including the use of a monofilament fiber debridement pad (Debrisoft® - Lohmann & Rauscher) in combination with an antimicrobial dressing.

       

      MATERIALS AND METHODS

      The survey includes data of 706 professional users located in the UK. The users were asked to treat chronic non-healing wounds by following a 2-weeks wound management pathway including mechanical debridement and an antimicrobial treatment. Clinicians reported on the outcomes and the potential impact on the healing of chronic wounds. Even if the clinicians were asked to follow the wound management pathway, 21% of them were only using the debridement pad without the antimicrobial treatment. This analysis compares these two groups, showing the impact of mechanical debridement in combination with antimicrobial treatment compared to mechanical debridement alone.

       

      RESULTS

      454 (64%) of the users followed the 2-weeks wound management pathway (Group A). 147 (21%) used Debrisoft alone (Group B). 105 (15%) did not give that information. 76% of the treated wounds were static/non-healing and 9% were healing. 15% of the users did not give that information. 94% of all wounds in Group A showed a visible change after 2 weeks, but only 79% in Group B (p<0.0001). For static wounds only 94% of patients in Group A and 85% in Group B (p<0.001) showed improvement and for non-static wounds 97% and 52% respectively (p<0,0001). On a scale of 1 (completely satisfied) to 5 (dissatisfied) the overall clinical outcome was rated 1.543 in Group A and 1.617 in Group B. The healing progression and skin improvement was rated 1,657 in Group A and 1,807 in Group B. The patient satisfaction was rated 1.593 in Group A and 1.778 in Group B.

       

      CONCLUSION

      In conclusion the debridement with Debrisoft® shows its capability to put a biofilm-infected non-healing wound into the position to heal. By using mechanical debridement in combination with antimicrobial treatment by following the 2-weeks wound management pathway the positive effect is even more prominent.

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    10. Poster

      Improving outcomes in chronic wound healing by following a 2 week pathway using monofilament fibre debridement pad* and antimicrobial regime

      Poster presented at EWMA 2017 03.05.2017 Amsterdam, Nederland

      Aim:

      This study set out to examine the impact of a biofilm pathway in chronic static wounds.

       

      Method:

      A survey of 500 nurses who had been using a Biofilm treatment pathway combining a monofilament fibre pad and a topical antimicrobial on static wounds for a period of two weeks was undertaken to gather information on wound healing in those patients who received the new treatment pathway.

       

      Results / Discussion:

      A total of 142 nurses, out of 171 respondents, completed all questions in the survey. 82 % of the patients (n=156) had a leg ulcer. The average duration of the wounds was 6 months prior to the change in treatment (range 2-52 weeks). 12 patients had wounds for longer than one year, with one patient having her wound for 11 years. These patients were not included in

      the statistical analysis. All wounds were reported as ‘static’ prior to implementing the change in treatment. A total of 66 (46%) wounds had healed following the change in treatment. 39 (58%) patients healed in 1 month or less, with 16 healed in 2 months and 11 taking more than 2 months to heal. A further 32 patients were recorded as having 50-75% healing since using the pathway, with 26 patients showing 25% healing.

       

      Conclusion:

      Although this data was non-comparative, it can be concluded that there is a positive effect from using a monofilament debridement pad in combination with antimicrobial dressings to remove and prevent biofilm build up in static wounds. This could result in significant cost savings to the health service and improved outcomes for patients with static chronic wounds.

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