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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

      The difficult case: NPWT for extensive soft tissue defects of the lower extremity

      Poster presented at EWMA 2022 23.05.2022 Paris, France

      Aim:

      We report on the case of a 14-year-old girl with extensive soft tissue defects on the right lower extremity up to the right hip following a traffic accident. The patient suffered a subtotal amputation of the right lower extremity with a rupture of the external iliac artery and the iliac vein.

       

      Method:

      After CTA, the pulseless, ischemic leg was treated with autologous arterial und venous vascular graft. Perfusion resumed 4 hours post-accident. Osteosynthesis was carried out using an external fixator. Despite fasciotomy, extensive soft tissue necrosis occurred on the right lower extremity. Due to pre-terminal multiple organ failure caused by SIRS, a large-area necrosectomy was performed and NPWT started. The occlusive dressing was applied to the entire right lower extremity including the anogenital area up to the iliac crest using a tubular bandage*.

       

      Results / Discussion:

      This method allowed for sufficient negative pressure on the entire hip area and the entire right lower extremity. Septic condition improved immediately. After stimulating wound granulation, the secondary, serial split skin coverage of the defects was possible.

       

      Conclusion:

      In the case of extensive soft tissue defects on the lower extremity with deep substance defects in the area of the hip and simultaneous external fixation on the pelvic ring as well as cystofix and colostoma creation, the establishment of an NPWT system typically is difficult and time-consuming. With the tubular bandage it was possible to use a reliable, reproducible, time-saving occlusive and elastic system for the NPWT.

    2. 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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    3. Journal article

      Pre-emptive active drainage of reflux (PARD) in Ivor-Lewis oesophagectomy with negative pressure and simultaneous enteral nutrition using a double-lumen open-pore film drain (dOFD)

      Surgical endoscopy 2022

      BACKGROUND

      Postoperative reflux can compromise anastomotic healing after Ivor-Lewis oesophagectomy (ILE). We report on Pre-emptive Active Reflux Drainage (PARD) using a new double-lumen open-pore film drain (dOFD) with negative pressure to protect the anastomosis.

      METHODS

      To prepare a dOFD, the gastric channel of a triluminal tube (Freka®Trelumina, Fresenius) is coated with a double-layered open-pore film (Suprasorb®CNP drainage film, Lohmann & Rauscher) over 25 cm. The ventilation channel is blocked. The filmcoated segment is placed in the stomach and the intestinal feeding tube in the duodenum. Negative pressure is applied with an electronic vacuum pump (- 125 mmHg, continuous suction) to the gastric channel. Depending on the findings in the endoscopic control, PARD will either be continued or terminated.

      RESULTS

      PARD was used in 24 patients with ILE and started intraoperatively. Healing was observed in all the anastomoses. The median duration of PARD was 8 days (range 4-21). In 10 of 24 patients (40%) there were issues with anastomotic healing which we defined as "at-risk anastomosis". No additional endoscopic procedures or surgical revisions to the anastomoses were required.

      CONCLUSIONS

      PARD with dOFD contributes to the protection of anastomosis after ILE. Negative pressure applied to the dOFD (a nasogastric tube) enables enteral nutrition to be delivered simultaneously with permanent evacuation and decompression.

      PMID 34973079
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    4. Journal article

      Management of esophageal perforations in infants by endoscopic vacuum therapy: A single center case series

      BMC gastroenterology 2022 22(1) 282

      BACKGROUND

      Endoscopic vacuum therapy (EVT) has become a standard treatment method for esophageal perforations in adults. However, experience with EVT in infants is scarce. In this retrospective case series, we report on four very young infants who were successfully treated with EVT for esophageal perforations of different etiology.

      METHODS

      Four infants were diagnosed with esophageal perforations on day 7, 32, 35 and 159 of life, respectively. The youngest one was prematurely born in the 31st week of pregnancy weighing 980 g only. Three infants had perforations due to foreign body insertion (nasogastric tube or pulling through of percutaneous endoscopic gastrostomy (PEG) tube through the esophagus). One child had an anastomotic dehiscence after Foker's surgery for atresia. In three children EVT was applied as first-line therapy for perforation, in one child EVT was a rescue therapy due to persisting leakage after surgical closure involving thoracotomy. Depending on the esophageal diameter, either an open-pore drainage film or polyurethane sponge was attached to a single-lumen 8 Fr suction catheter, endoscopically (or fluoroscopically by wire-guidance) placed into the esophagus (intraluminal EVT) and supplied with continuous negative pressure (ranging between 75 and 150 mmHg). The EVT system was exchanged twice per week.

      RESULTS

      Complete closure of the perforation/leakage could be achieved in all four infants (100%) after 22 days of continuous EVT (median value; range 7-39) and 4.5 EVT exchanges (median value; range 1-12). No serious adverse events occurred.

      CONCLUSIONS

      EVT is an effective and safe addition to our therapeutic armamentarium in the management of esophageal perforations irrespective of its etiology. Here we prove the feasibility of EVT even in very young infants. The use of an extra thin vacuum open-pore drainage film is helpful to cope with the small esophageal diameter. EVT settings and exchange rates similar to those known from adult treatment were used.

      PMID 35658914
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    5. Journal article

      Endoscopic vacuum therapy in the upper gastrointestinal tract: When and how to use it

      Langenbeck's archives of surgery 2022

      BACKGROUND

      Endoscopic vacuum therapy (EVT) has emerged as a novel treatment option for upper gastrointestinal wall defects. The basic principle of action of EVT entails evacuation of secretions, removal of wound debris, and containment of the defect. Furthermore, there is increasing evidence that EVT reduces interstitial edema, increases oxygen saturation, and promotes tissue granulation and microcirculation. Various devices, such as macroporous polyurethane sponge systems or open-pore film drains, have been developed for specific indications. Depending on the individual situation, EVT devices can be placed in- or outside the intestinal lumen, as a stand-alone procedure, or in combination with surgical, radiological, and other endoscopic interventions.

      PURPOSE

      The aim of this narrative review is to describe the current spectrum of EVT in the upper gastrointestinal tract and to assess and summarize the related scientific literature.

      CONCLUSIONS

      There is growing evidence that the efficacy of EVT for upper GI leakages exceeds that of other interventional treatment modalities such as self-expanding metal stents, clips, or simple drainages. Owing to the promising results and the excellent risk profile, EVT has become the therapy of choice for perforations and anastomotic leakages of the upper gastrointestinal tract in many centers of expertise. In addition, recent clinical research suggests that preemptive use of EVT after high-risk upper gastrointestinal resections may play an important role in reducing postoperative morbidity.

      PMID 35041047
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    6. Journal article

      Het verhaal van Amber: Complicaties na een Gastric bypass

      Nederlands Tijdschrift Voor Huidzorg 2022 12(2)

      Amber is 42 jaar en moeder van 3 prachtige kinderen. Van kleins af aan was ze al redelijk gezet en dat bleef zo ondanks veel pogingen om af te vallen. Haar vader is overleden vlak na haar geboorte, ook hij was veel te zwaar en had te hoge cholesterol waarden. Amber dacht: dit gaat mij niet gebeuren en ik ga hulp zoeken om af te vallen. Ze kwam in 2016 in het ziekenhuis in Almelo bij de internist terecht en kreeg daar allerlei onderzoeken inclusief een erfelijkheidsonderzoek in verband met haar vader. Tijdens de tweede afspraak bij de internist werd ze goed met haar neus op de feiten gedrukt. Amber: ‘Hij zei, er moet gauw iets gebeuren want anders wordt u geen 38 jaar oud. Hier schrok ik dus behoorlijk van. Mijn bloeddruk was te hoog, ik rookte, had diabetes en een super hoog cholesterol gehalte.’ Al snel kreeg Amber groen licht voor een gastric bypass. ‘Maar daarvoor moest ik wel een jaar lang een voorbereidend traject volgen’. De operatie vond uiteindelijk plaats in april 2017.

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    7. Journal article

      First report of closure of an iatrogenic recto-vesical fistula solely using endoscopic negative pressure therapy

    8. 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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    9. Poster

      Evaluation of different schort-stretch compression systems with zinc for stasis dermatitis

      Poster presented at EWMA 2021 26.10.2021 Virtual Conference

      Aim: Stasis dermatitis is a common inflammatory dermatosis of the lower extremities. The mainstay is treatment of the underlying chronic venous insufficiency (CVI) with multimodal therapy, which is aimed at reducing oedema and venous hypertension. External compression with short stretch bandages, impregnated with zinc oxide, is used as first line therapy simultaneously reducing swelling and employing anti-inflammatory effects of zinc. Our aim was to compare two different short-stretch systems with zinc oxide, both from the patients and staff point of view.

      Method: 10 patients with bilateral stasis dermatitis were included in the study. 2 patients had only CVI, while 8 patients had phlebolymphoedema. Both legs were treated simultaneously. Self-adherent two-layer bandaging system with zinc1 was applied on one leg and zinc paste bandage2 and adhesive short-stretch system3 was applied on the other leg for 7 days. A questionnaire with was filled out by the patients and the staff. Overall skin inflammation improvement was also assessed.

      Results: Both systems proved to be easy and fast to apply. There were no differences in slippage or compliance during wear. Patients had no difficulties with mobility and wearing footwear while using either compression systems. 90% of patients reported that self-adherent bandaging system was at least as comfortable to wear as adhesive bandage. The skin condition was equally improved with both systems.

      Conclusion: Both self-adherent and adhesive short-stretch systems with zinc proved to be suitable treatment of stasis dermatitis in patients with venous insufficiency and phlebolymphoedema.

      Products Varicex
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    10. Poster

      Use of monofilament fibre debridement pad for hyperkeratosis in the community

      Poster presented at EWMA 2021 26.10.2021 Virtual Conference

      Aim:

      82 year old man with diabetes, congestive cardiac failure and mixed arterial vascular insufficiency had been treated in the home for diabetic health management and a chronic history of leg ulcers.

      Patient was suffering from hyperkeratosis and previous treatment was an elastic tubular bandage which was left on for 24 hours a day, 7 days a week.

      Method:

      A solution was required which would manage the hyperkeratosis, prevent further skin breakdown and prevent bacterial or fungal build up in the feet and legs. The solution had to be cost effective, gentle on skin and ensure quick, easy removal of excessive skin and debris.

      A monofilament fibre debridement pad* was used to clean, remove and descale the hyperkeratosis without damaging healthy skin.

      Results / Discussion:

      After initial treatment with monofilament fibre debridement pad, there was visible improvement and reduction in hyperkeratosis, no itch and reduction in odour.

      Once dead skin and hyperkeratosis was removed, patient was put on a structured skin care regime including cleansing, exfoliation and replenishing the skin barrier using emollients.

      Conclusion:

      Hyperkeratosis of the lower limb is a common skin condition that typically affects patients with chronic venous insufficiency. Patients are often embarrassed by the appearance of their skin, the hyperkeratotic scales and the unpleasant odour. The monofilament fibre debridement pad can be used by all healthcare professionals working in the community, and by patients. It’s effectiveness and ease of use may encourage patients or carers to take an active role in their care.

      Products Debrisoft Pad
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