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Clinical Newsletter

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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 outcomes of a new reusable fibreglass and polyester combined total contact cast system (Cellacast Lohmann and Rauscher) in the management of plantar ulcers

    Poster presented at EWMA 2023 03.05.2023 Milan, Italy
  2. Poster

    Antibiofilm performance of silver nanoparticles and new silver nanoparticle wound dressing

    Poster presented at SAWC Spring 2023 26.04.2023 National Harbor, United States

    Introduction:

    A new, non-silver cellulose-based wound dressing has demonstrated to be effective against biofilms and preventing bacterial penetration. The fibres of the new dressing are coated with a novel antibiofilm formulation containing PHMB (polyhexanide).

    Methods:

    The biofilm method used in the study was based on a gauze model developed by Bowler and Parsons, 2016. 1 In the first step, circular pieces of 1.6 cm sterile gauze were punched out before being transferred into sterile 100 ml Erlenmeyer flasks and submerged in 25 ml of liquid bacterial culture containing either S.aureus or P.aeruginosa at approximately 1-5 x 105 CFU/ ml. The Erlenmeyer flasks were subsequently shaken for 48h in order to coat the gauze with a mature biofilm.

    Each piece of gauze was then placed onto an individual agar plate and covered with a 3.2 cm disk of the test dressing and wetted with 1.5 ml of simulated wound fluid. Finally, the test dressings were covered with a piece of silicon dressing and the plate closed with parafilm.

    Bacterial penetration testing was performed by saturating 4.2 x 4.2 cm dressing samples with aliquots of SWF. Dressings were subsequently incubated (pre-conditioned) at 37°C for 6-days. After this period, the cut samples were placed onto fresh agar plates and inoculated with bacterial suspension containing 1x 108 CFU/ml evenly around the edge of the dressing. Petri dishes were then incubated for 24h, the dressings removed and plates inspected for growth.

    Results:

    The new, non-silver wound dressings completely killed all the bacteria in the both the S. aureus and P.aeruginosa biofilms. In comparison, a silver based competitor dressing did not remove the biofilm for either bacteria.

    Bacterial penetration was also prevented in the new dressing.

    Discussion:

    Initial evidence would suggest the new non-silver dressing is highly effective against biofilms and preventing bacterial penetration.

  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) 26 31

    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

    Adjustable compression wraps: stretch, interface pressures and static stiffness indices

    International angiology : a journal of the International Union of Angiology 2023

    BACKGROUND

    Adjustable compression wraps (ACWs) may represent the future of compression for the treatment of the most severe stages of chronic venous diseases and lymphedema. We tested in five healthy subjects: Coolflex® from Sigvaris®; Juzo wrap 6000®, Readywrap® from Lohmann Rauscher®; Juxtafit® and Juxtalite® from Medi®, Compreflex® from Sigvaris®. The objective of this pilot study was to study the stretch, interface pressures, and Static Stiffness Index (SSI) of the six ACWs applied to the leg.

    METHODS

    The stretch was evaluated by stretching the ACWs to their maximum length. Interface pressure measurements were performed using a PicoPress® transducer and a probe placed at point B1. Interface pressures were measured in the supine resting position and in the standing position. We calculated the SSI. We started the measurements at 20 mmHg in the supine position and increased the pressures by 5 mmHg to 5 mmHg.

    RESULTS

    Coolflex® (inelastic ACW) cannot exceed a maximum pressure of 30 mmHg at rest with a maximum SSI of approximately 30 mmHg. Juzo wrap 6000® (a 50% stretch) and Readywrap® (a 60% stretch) have a profile of stiffness very near one to the other. The optimal stiffness for Juzo is from 16 mmHg to of 30 mmHg for a resting pressure between 25 mmHg and 40 mmHg. For Readywrap, the optimal stiffness is from 17 mmHg to 30 mmHg with a maximum SSI of 35mmHg. The optimal application zone of this wrap at rest is 30 to 45 mmHg. Juxtafit®, Juxtalite® and Compreflex® (respectively 70%, 80%, 124% stretch) can be applied with pressures above 60 mmHg but with maximum SSI of 20 mmHg for Circaid® and>30 mmHg for Compreflex®.

    CONCLUSIONS

    This pilot study allows us to propose a classification of wraps according to their stretch: inelastic ACW and short or long stretch ACW (50-60% and 70%, 80%, and 124% stretch). Their stretch and stiffness could help to better determine what could be expected of ACWs in clinical practice.

    PMID 36795457
  5. Journal article

    Endoscopic negative pressure therapy for duodenal leaks

    Frontiers in Surgery 2023 10

    Background and study aim: Endoscopic negative pressure therapy (ENPT) is well established in the treatment of perforations of various etiologies in the upper and lower gastrointestinal tract. For duodenal perforations exist only case reports and series. Different indications are possible for ENPT in duodenal position: primary therapy for leaks, preemptive therapy after surgery for example, after ulcer suturing or resection with anastomoses, or as second line therapy in cases of recurrent anastomotic insufficiencies with leakage of duodenal secretion.

     

    Methods: A retrospective 4-year case series of negative pressure therapy in duodenal position indicated by different etiologies and a comprehensive review of current literature on endoscopic negative pressure duodenal therapy are presented.

     

    Results: Patients with primary duodenal leaks n= 6 and with duodenal stump insufficiencies n = 4 were included. In seven patients ENPT was the first line and sole therapy. Primary surgery for duodenal leak was performed in n = 3 patients. Mean duration of ENPT was 11.0 days, mean hospital stay was 30.0 days. Re-operation after start of ENPT was necessary in two patients with duodenal stump insufficiencies. Surgery after termination of the ENPT was not necessary in any patient.

     

    Discussion: In our case series and in the literature, ENPT has been shown to be very successful in the therapy of duodenal leaks. A challenge in ENPT for duodenal leaks is the appropriate length of the probe to safely reach the leak and keep the open pore element at the end of the probe in place despite intestinal motility.

  6. Journal article

    Intrathorakale Unterdrucktherapie des Pleuraempyems unter Einsatz einer offenporigen Drainagefolie

    Chirurgie (Heidelberg, Germany) 2023 94 (4) 349 360

    INTRODUCTION

    We report our initial experience with intrathoracic negative pressure therapy (ITNPT) in the stage-adjusted therapy of pleural empyema (PE) based on a case series.

    MATERIALS AND METHODS

    ITNPT represents a further development in negative pressure therapy that is designed to be used in the thoracic cavity. After thoracic surgical open debridement, an intrathoracic negative pressure dressing was inserted. The drainage elements used were a thin open-pore double-layer drainage film (OF) with open-pore polyurethane foams (PUF). Only the OF was placed in direct contact with the lung parenchyma. Negative pressure was generated using an electronic pump (continuous suction, -75 mm Hg). In revision thoracotomies, ITNPT was stopped or continued depending on local findings.

    RESULTS

    31 patients with stage II and III pleural empyemas were treated. ITNPT was administered at the time of primary procedure (n = 17) or revision (n = 14). ITNPT was given over a duration of m = 10 days (2-18 days), change interval m = 4 d (2-6 d). The application of intrathoracic negative pressure dressings was performed m = 3.5 (1-6) times. The empyema cavity continuously reduced in size and was cleansed by the suction. The OF has a minimum intrinsic volume with maximum absorption surface. Once negative pressure is established, there is no intrathoracic dead volume and the parenchyma can expand.

    DISCUSSION

    The protective material properties of OF make ITNPT suitable for the treatment of pleural empyema. Targeted local intrathoracic drainage of the septic focus is a possible adjunct to surgery. The treatment regimen requires surgical dressings to be changed repeatedly. The method is suitable for the treatment of complex stage II and III pleural empyemas.

    CONCLUSION

    The OF can be used as an intrathoracic drainage element for ITNPT in pleural empyema. This new application option expands the range of indications for negative pressure therapy.

    ZUSAMMENFASSUNG

    EINLEITUNG: Anhand einer Fallserie berichten wir über unsere ersten Erfahrungen mit einer intrathorakalen Unterdrucktherapie (ITNPT) in der stadienadaptierten Therapie des Pleuraempyems (PE).

    MATERIAL UND METHODEN

    Die ITNPT ist eine Weiterentwicklung der Unterdrucktherapie für die intrathorakale Anwendung. Nach thoraxchirurgischem offenen Débridement wurde ein intrathorakaler Unterdruckverband installiert. Als Drainageelemente verwendeten wir eine dünne offenporige doppellagige Drainagefolie (OF) mit offenporigen Polyurethanschäumen (PUS). Ausschließlich die OF wurde in direktem Kontakt zum Lungenparenchym angelegt. Die Unterdruckerzeugung erfolgte mit einer elektronischen Pumpe (kontinuierlicher Sog, −75 mm Hg). In der Revisionthorakotomie wurde je nach Lokalbefund die ITNPT beendet oder fortgeführt.

    ERGEBNISSE

    Es wurden 31 Patienten im PE-Stadium II und III behandelt. Die ITNPT erfolgte bereits beim Primäreingriff (n = 17) oder bei Revision (n = 14). Die ITNPT erfolgte über einen Dauer von m = 10 Tagen (2–18 Tage), Wechselintervall m = 4 d (2–6 d). Die intrathorakaler Unterdruckverband-Anlage wurde in m = 3,5 (1–6) mal vorgenommen. Die Empyemhöhle verkleinerte und reinigte sich unter dem Sog kontinuierlich. Die OF hat ein minimales Eigenvolumen bei maximaler Resorptionsoberfläche. Nach Anlage des Unterdrucks besteht kein intrathorakales Totvolumen, das Parenchym kann sich entfalten.

    DISKUSSION

    Die schonenden Materialeigenschaften der OF ermöglichen die ITNPT zur Behandlung des Pleuraempyems. Es ist eine gezielte lokale intrathorakale Sanierung des septischen Focus in Ergänzung zur operativen Therapie möglich. Das Behandlungsregime erfordert wiederholte operative Verbandswechsel. Die Methode ist geeignet zur Behandlung komplizierter PIeuraempyeme im Stadium II und III.

    KONKLUSION

    Die OF kann als intrathorakales Drainageelement zur ITNPT bei Pleuraempyemen verwendet werden. Das Indikationsspektrum der Unterdrucktherapie erweitert sich um diese neue Anwendungsoption.

    PMID 36754892
  7. 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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  8. Journal article

    Minimally invasive intrathoracic negative-pressure therapy and flexible thoracoscopy (FlexVATS) for patients with pleural empyema

    Scientific Reports 2023 13 (1) 10869

    To determine whether a new surgical method using a flexible endoscope (FlexVATS) to perform sparing debridement and apply negative-pressure therapy without extensive decortication may be an alternative treatment option for empyema. Surgical treatment of pleural empyema is associated with considerable postoperative complications and mortality rates, and alternative treatment options are being explored to improve patient outcomes. This was a prospective case series. Seventeen consecutive patients treated with FlexVATS between February 2021 and August 2022 were included in the study. Only patients for whom FlexVATS was the first therapeutic intervention for pleural empyema were included. Treatment success, defined as infection resolution, was the primary endpoint of the study. The secondary endpoints were length of hospital stay, 90-day mortality, and empyema cavity volume reduction. Patients who had previously been treated for pleural empyema by either drainage or surgery were excluded. The trial was performed as a single-centre study at a tertiary medical centre in Germany. In total, 17 patients with pleural empyema were included in the study. The median (IQR) duration of vacuum treatment was 15 days (8-35 days). Twelve of the 17 (71%) patients were successfully treated, and a significant reduction in the empyema cavity volume was observed. 41% of the dressing changes were performed outside the operating room. Compared with a historic cohort of conventionally treated patients (decortication via VATS or thoracotomy), the 90-day mortality rates tended to be lower without reaching statistical significance. Three patients (18%) died in hospital during treatment. No negative pressure-therapy-related complications were observed. FlexVATS therapy is a promising alternative therapy for both healthy and debilitated patients with pleural empyema. Larger randomised trials are required to validate this treatment option.

    PMID 37407677
  9. Journal article

    Complex physical therapy employing self-adjusting garment (ReadyWrap®) in breast cancer-related lymphedema cases in Brazilian women: a protocol for a randomized controlled trial

    Trials 2023 24 (1) 549

    BACKGROUND

    Lymphedema is a common complication following breast cancer treatment. The aim of this study is to evaluate the effectiveness of a self-adjusting compression garment (ReadyWrap®) in reducing (phase 1) and maintaining (phase 2) upper limb volume in women presenting breast cancer-related lymphedema.

    METHODS

    This study will comprise a randomized, controlled, single-blind clinical trial concerning women with breast cancer-related lymphedema undergoing treatment at a public cancer treatment reference hospital in the city of Rio de Janeiro, Brazil. The intervention will be carried out by adapting self-dressing versus the standard treatment of compressive bandaging (phase 1) and compressive mesh (phase 2). Both groups will be assessed at the beginning and end of intensive treatment and followed up for up to 12 months to evaluate immediate and late outcomes. Assessments will be carried out by physical upper limb examination (inspection, palpation, volume, dynamometry, and thermography) and questionnaires application to assess patient's quality of life pertaining to the health, functionality, and symptoms of the affected upper limb, as well adverse effects and adherence to treatment. Data will be analyzed descriptively and analytically through univariate and multiple linear regressions. P values < 0.05 will be considered statistically significant.

    DISCUSSION

    This study will evaluate the effectiveness of a self-adjustable garment (ReadyWrap®) in the treatment of lymphedema secondary to breast cancer in Brazilian women compared to the gold standard treatment for limb volume reduction (phase 1) and maintenance (phase 2) phases comprising, respectively, a compressive bandaging and a compressive mesh. The outcome results will provide data based on both quantitative responses and self-reported participant outcomes. The study will also assess the cost-effectiveness of the ReadyWrap® treatment versus standard care. Finally, we expect to reaffirm one more product/therapy as a treatment for this extremely complex and impactful condition following the data analysis.

    TRIAL REGISTRATION

    NCT04934098 [Clinical trials phase 1]. Registered on June 22, 2021. NCT04881604 [Clinical trials phase 2]. Registered on May 11, 2021.

    PMID 37608354
  10. Journal article

    Endoscopic vacuum therapy for esophageal perforation: a multicenter retrospective cohort study

    Endoscopy 2023 55 (9) 859 864

    BACKGROUND : Endoscopic vacuum therapy (EVT) is a novel treatment for esophageal perforations. This study aimed to describe initial experience with EVT of esophageal perforations due to iatrogenic cause, Boerhaave syndrome, or other perforations not related to prior upper gastrointestinal surgery. METHODS : Data from patients treated with EVT for esophageal perforation at five hospitals in three European countries, between January 2018 and October 2021, were retrospectively collected. The primary end point was successful defect closure by EVT, with or without the use of other endoscopic treatment modalities. Secondary end points included mortality and adverse events. RESULTS : 27 patients were included (median age 71 years). The success rate was 89 % (24/27, 95 %CI 77-100). EVT failed in three patients: two deceased during EVT (septic embolic stroke, pulmonary embolism) and one underwent esophagectomy due to a persisting defect. Two adverse events occurred: one iatrogenic defect expansion during sponge exchange and one hemorrhage during sponge removal. Median treatment duration was 12 days (interquartile range [IQR] 6-16) with 1 sponge exchange (IQR 1-3). CONCLUSION : EVT is a promising organ-preserving treatment for esophageal perforations, with a success rate of 89 %. More experience with the technique and indications will likely improve success rates.

    PMID 36828030

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