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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

      Secondary wound closure with a new transparent negative-pressure dressing

      Chirurgie 2023

      Secondary healing surgical wounds can be treated with negative-pressure therapy. Dressing changes can be painful due to the strong adherence of the polyurethane foam placed in the wound. After debridement and conditioning of the wound bed, secondary surgical wound closure with a surgical suture can be performed. Cutaneous negative-pressure therapy is used preventively after primary surgical suturing. Descriptions for secondary wound closure without a surgical suture are not known to date. The preparation and handling of an innovative transparent dressing for the cutaneous application of negative-pressure therapy is demonstrated here. The dressing assembly consists of a transparent drainage film and a transparent occlusion film. Negative pressure is applied via a tubing connector using a negative pressure pump. A new method of secondary wound closure using the transparent negative-pressure dressing is presented based on a case example. The treatment cycle with instructions for making the dressing is shown in a video.

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    2. Journal article

      Endoscopic negative-pressure treatment: From management of complications to pre-emptive active reflux drainage in abdomino-thoracic esophageal resection — A new safety concept for esophageal surgery

      Chirurgie (Heidelberg, Germany) 2023

      INTRODUCTION

      Early postoperative reflux (PR) can compromise anastomotic healing after Ivor Lewis esophagectomy (ILE) and poses a risk for aspiration. Anastomotic insufficiency is the most threatening surgical complication. We present the protective method of pre-emptive active reflux drainage (PARD) with simultaneous enteral feeding. We report our experience with this new safety concept in esophageal surgery in a cohort of 43 patients.

      MATERIALS AND METHODS

      For PARD we use a double lumen open porous film drainage (dOFD). To create the dOFD, the gastric tube of a Trelumina probe (Freka®Trelumina, Fresenius) is coated with a double-layered open-pore drainage film (Suprasorb®CNP drainage film, Lohmann & Rauscher) over a length of 25 cm. The dOFD is endoscopically inserted into the tubular stomach intraoperatively after completion of the anastomosis. Continuous negative pressure is applied with an electronic pump (-125 mm Hg). The PR is continuously aspirated completely and the stomach and anastomotic region are decompressed. At the same time, nutrition is delivered via an integrated intestinal tube. Depending on the results of the endoscopic control after 5 days, PARD is either continued or terminated.

      RESULTS

      During the observation period (2017-2023), PARD was used in all patients (n = 43) with ILE. The healing rate under PARD was 100% and healing was observed in all anastomoses. No additional endoscopic procedures or surgical revisions of the anastomoses were required. The median duration of PARD was 8 days (range 4-21). We observed problems in the healing of the anastomosis in 20 of 43 patients (47%) for whom we defined endoscopic criteria for at-risk anastomosis.

      CONCLUSIONS

      Our results suggest that PARD has a strong protective effect on anastomotic healing and may reduce the risk of anastomotic insufficiency. The integrated feeding tube of the dOFD allows early postoperative enteral feeding while simultaneously applying negative pressure. PARD appears to prevent the negative consequences of impaired anastomotic healing.

      ZUSAMMENFASSUNG

      EINLEITUNG: Der früh postoperative Reflux (PR) kann die Anastomosenheilung nach Ivor-Lewis-Ösophagektomie (ILE) beeinträchtigen und stellt ein Risiko für Aspirationen dar. Die Anastomoseninsuffizienz ist die bedrohlichste chirurgische Komplikation.Wir stellen die protektive Methode der pre-emptiven aktiven Refluxdrainage (PARD) mit gleichzeitiger enteraler Ernährung vor. Wir berichten über unsere Erfahrungen mit dem neuen Sicherheitskonzept für die Ösophaguschirurgie an einem Patientenkollektiv von 43 Patienten.

      MATERIALIEN UND METHODEN

      Zur PARD nutzen wir eine doppellumige offenporige Foliendrainage (dOFD). Zur Herstellung der dOFD wird der gastrale Schenkel einer Trelumina Sonde (Freka®Trelumina, Fresenius) über eine Länge von 25 cm mit einer doppellagigen offenporigen Drainagefolie (Suprasorb®CNP Drainagefolie, Lohmann & Rauscher) beschichtet. Die dOFD wird nach Fertigstellung der Anastomose intraoperativ endoskopisch im Schlauchmagen eingeführt. Es wird ein kontinuierlicher Unterdruck mit einer elektronischen Pumpe angelegt (−125 mm Hg). Der PR wird permanent komplett abgesaugt, der Magen und die Anastomosenregion dekomprimiert. Gleichzeitig wird über eine integrierte Intestinalsonde ernährt. Je nach den Ergebnissen der endoskopischen Kontrolle nach 5 Tagen wird PARD entweder fortgesetzt oder beendet.

      ERGEBNISSE

      Im Beobachtungszeitraum (2017–2023) wurde PARD bei allen Patienten (n = 43) mit ILE eingesetzt. Die Heilungsrate unter PARD betrug 100 %, bei allen Anastomosen wurde eine Abheilung beobachtet. Es wurden keine zusätzlichen endoskopischen Eingriffe oder chirurgische Revisionen an den Anastomosen erforderlich. Die mediane Dauer der PARD betrug 8 Tage (Spanne 4–21). Bei 20 von 43 Patienten (47 %) sahen wir Probleme in der Anastomosenheilung, für die wir endoskopische Kriterien der Risikoanastomose definierten.

      SCHLUSSFOLGERUNG

      Unsere Ergebnisse legen nahe, dass PARD einen starken protektiven Effekt auf die Anastomosenheilung hat und das Risiko der Anastomoseninsuffizienz reduzieren kann. Die integrierte Ernährungssonde der dOFD ermöglicht simultan zur Unterdruckausübung die frühpostoperative enterale Ernährung. PARD scheint die negativen Folgen einer gestörten Anastomosenheilung zu verhindern.

      PMID 38085297
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    3. Journal article

      A real-world study of a calcium alginate dressing for various etiology wounds on clinical performance, usability, and safety

      Wounds 2023 35(2) 2631

      Introduction. Complex wounds require a moist wound healing environment and exudate control. Alginate dressings are highly absorbable and available as sheets for superficial wounds and ropes for deeper wounds. Objective. This study evaluates the real-world performance of a conformable CAD containing mannuronic acid for various wound types. Materials and Methods. The usability and safety of the tested CAD were evaluated in adult patients with various wound types. Further endpoints were clinician satisfaction with dressing application and suitability for wound type and their opinion of the tested CAD compared with other dressings of this type. Results. The study included 83 patients with exuding wounds (42 male [51%]; 41 female [49%]) and a mean age of 74.54 years (SD ± 15.54 years). Thirteen clinicians (76%) (x = 1.24) rated the first CAD application as very easy, 4 (24%) as easy, and 1 (6%) as not easy. The time for dressing application was ranked as very good (x = 1.65) by 8 clinicians (47%), while 7 (41%) rated the time for application as good, and 2 (12%) gave a satisfactory rating. Conclusion. The CAD sheet and rope were safe to use and fit for purpose in wounds of various etiologies. In addition, the dressing was easy to handle and remove, formed a gel faster than other alginates, and outperformed other previous products.

      Products Suprasorb A Pro
      PMID 36877937
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    4. Journal article

      The Role of Open-Pore Film Drainage Systems in Endoscopic Vacuum Therapy: Current Status and Review of the Literature

      Visceral medicine 2023 39(6) 177183

      BACKGROUND

      Endoscopic vacuum therapy (EVT) is an increasingly popular endoscopic technique used for the treatment of wall defects in the gastrointestinal tract. Open-pore film drainage (OFD) systems are a new addition to the armamentarium of EVT and have shown encouraging results in a wide spectrum of applications. The aim of this review is to summarize the current literature on the applications of OFD systems in the gastrointestinal tract.

      SUMMARY

      Open-pore film drainage (OFD) systems have been used for the treatment of several defects of the gastrointestinal tract. The small size and easy placement of these devices make them very useful, particularly for the treatment of defects that are small in size or difficult to reach. OFDs have been successfully used for both perforations and anastomotic leaks in various locations, with most reports focusing on the treatment of duodenal defects, although successful applications in the esophagus, stomach, and colon have also been reported. Lately, the role of OFDs in preemptive EVT has also been explored.

      KEY MESSAGES

      OFD systems are easy to use, particularly for small defects and challenging localizations. The current literature, consisting mainly of small case series and case reports, shows encouraging results, but further prospective studies are needed to explore and verify the indications and technical aspects of this innovative method.

      PMID 38205271
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    5. Journal article

      Applications of endoscopic vacuum therapy in the upper gastrointestinal tract

      World journal of gastrointestinal endoscopy 2023 15(6) 420433

      Endoscopic vacuum therapy (EVT) is an increasingly popular treatment option for wall defects in the upper gastrointestinal tract. After its initial description for the treatment of anastomotic leaks after esophageal and gastric surgery, it was also implemented for a wide range of defects, including acute perforations, duodenal lesions, and postbariatric complications. Apart from the initially proposed handmade sponge inserted using the "piggyback" technique, further devices were used, such as the commercially available EsoSponge and VAC-Stent as well as open-pore film drainage. The reported pressure settings and intervals between the subsequent endoscopic procedures vary greatly, but all available evidence highlights the efficacy of EVT, with high success rates and low morbidity and mortality, so that in many centers it is considered to be a first-line treatment, especially for anastomotic leaks.

      PMID 37397978
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    6. Poster

      Wound bed preparation of a sacral pressure injury for dermal template using autolytic debridement

      Poster presented at Wounds Australia 2022 Conference 14.09.2022 Sydney

      Situation

      A 65-year-old male bed bound patient with a BMI of 16 kg/m², a schizoid personality disorder, former strong alcoholism and an MCA stroke in 2019 with low rehabilitation potential, was presented with a sacral pressure injury to the District Nursing Service.

       

      Action(s) taken/ treatment provided

      The pressure injury was subjected to sharp debridement to remove the hard necrotic tissue. For further autolytic debridement, the wound was treated with a hydrogel wound dressing*. For exudate management, a superabsorbent wound dressing** was used as a secondary association. In the first week, the wound was additionally debrided mechanically. However, since this resulted in more arterial bleeding, treatment completely switched to autolytic debridement. Dressing changes were completed daily by Rest Home staff with weekly input from the District Nurse.

       

      Outcome(s)

      After 5 days of autolytic debridement, dark eschar started to soften. Further maceration of the peri wound skin was prevented by the superabsorbent dressing via absorbing high quantities of exudate. After 15 days, the necrotic areas were starting to lift up. Granulation on some areas of the wound bed developed. After 28 days, some edges of the wound bed had partially healed. After 43 days the wound had healed to such an extent that autolytic debridement was no longer indicated and application of a dermal template commenced.

       

      Lesson(s) learned

      The hydrogel wound dressing in combination with the superabsorbent dressing were able to debride and prepare the wound bed for the next step of application with a dermal template.

    7. 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.

    8. 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
    9. Journal article

      Comparison of the efficacy of novel non-invasive mechanical debridement methods – sterile sponge, monofilament fibre cloth and non-woven cloth impregnated with sodium hyaluronate and phospholipids in relation to traditional sterile gauze

      Advances in Dermatology and Allergology 2022 39(5) 856864

      Introduction: According to the European guidelines, the first step for local wound preparation is debridement, which stands for removing of devitalized tissue such as slough or necrosis. There are numerous types of debridement, but not all of them can be performed by non-specialists. Most of the research investigating efficiency of novel debridement products are carried out or funded by pharmaceutical companies.

      Aim: To compare the efficacy of relative necrotic tissue removal after 30 days on patients subjected to debridement with sterile sponge, monofilament fibre cloth, non-woven cloth impregnated with sodium hyaluronate and phospholipids and traditional sterile gauze.

      Material and methods: By use of photographic documentation at 7 days’ intervals and planimetry methods, the total wound surface area and sloughy tissue area was measured.

      Results: Results have shown that monofilament cloth was the most effective, removing on average 63.44 ±32.91% of necrotic tissue after the first procedure and 74.65 ±30.95% within 30 days of application, in comparison to the sterile gauze group that had on average only 23.53 ±19.16% of necrotic tissue removed at day 0 and 44.95 ±31.47% removed at day 30. Moreover, patients using all 3 products tested reported higher satisfaction with that treatment than those treated with gauze.

      Conclusions: Results imply that all those methods could be considered as they are well accepted by patients and cause less pain during the procedure, which is essential for good compliance and complete resolution of the lesions.

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    10. Journal article

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

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