Publication search

    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

      Effects of lower limb muscle strengthening on interface pressure in older adults undergoing inelastic compression: Randomized controlled clinical trial

      Phlebology 2024 2147483647

      OBJECTIVE

      To analyze the effects of lower limb muscle strengthening on interface pressure (IP), static stiffness index (SSI), dynamic stiffness index (DSI), and walking pressure amplitude (WPA) in older adults undergoing inelastic compression therapy.

      METHOD

      Forty-three healthy older adults of both sexes (Age: 66.2 ± 4.4 years) met the eligibility criteria and completed all stages of the study (Resistance Training - RT: N = 20; Control - CONT: N = 23). Body composition, strength and functional mobility of lower limbs, IP, SSI, DSI, and WPA were evaluated before and after intervention.

      RESULTS

      The two-way ANOVA with repeated measures demonstrated a significant time-group interaction effect on muscular strength for 1-RM [F (1, 41) = 21.091; p ≤ 0.001], IP in the orthostatic position [F (1, 41) = 5.124; p ≤ 0.05], minimum WPA [F (1, 41) = 10.999; p ≤ 0.05], maximum WPA [F (1, 41) = 8.315; p ≤ 0.05], DSI minimum (F (1, 41) = 4.608; p ≤ 0.05), DSI maximum (F (1, 41) = 8.926; p ≤ 0.05), and on the delta DSI (F (1, 41) = 7.891; p ≤ 0.05).

      CONCLUSIONS

      In RT group, the increase in lower limb muscle strength was accompanied by an increase in IP in foot dorsiflexion and plantar flexion maneuvers, both in the standing position (DSI) and during gait (WPA).

      Products Rosidal K
      PMID 38369821
      Downloads Citation (RIS)
    2. Journal article

      Performance of an adjustable compression wrap in occupational leg swelling

      Phlebology 2024 2147483647

      BACKGROUND

      Edema in some subjects worsens over time and wraps help to reduce the leg volume.

      MATERIAL AND METHODS

      An adjustable compression wrap was tried on volunteers for 5 h and volumes measured in each limb before and after wrapping using a 3D surface scanner (HandySCAN 3D®) to estimate the volume of the leg. The contralateral leg was used as control.

      RESULTS

      We observed a significant decrease in volume in the wrap legs and an increase in the control legs (p < .001), both in the lower part of leg (p = .001) and in the upper part (p = .001).

      CONCLUSIONS

      Using the Readywrap® for 5 hours significantly reduces the leg volume. This study enables Readywrap to be studied in a population that is easy to observe in the context of a research program. The Handyscan3D® was shown accurate and reproducible to assess leg volume in future studies.

      PMID 38193832
      Downloads Citation (RIS)
    3. Journal article

      Évolution des pressions et des rigidités de différents bandages de compression étudiées sur une jambe d’Hiraï.

      Phlébologie 2023 76(1) 17

      Hiraï a mis au point un dispositif permettant d’évaluer les performances in vitro de différents systèmes de compression.

      L’étude de sept bandages (Biflex 16, Urgo K2, Urgo K1, Coban 2, Biflex kit, Rosidal K et Rosidal Sys) sur la jambe d’Hiraï a permis une analyse précise de l’évolution de leur pression et de leur rigidité.

      Ces bandages ont été appliqués avec une pression de 45 ± 2 mmHg au point B1, 100 manœuvres d’étirement ont alors été réalisées.

      Une diminution de la moyenne des pressions pré-étirement est plus marquée pour Rosidal K, Urgo K1 et Coban 2 que pour les autres bandages.

      Biflex 16 n’est pas un bandage rigide.

      Urgo K1, Urgo K2, Coban 2, Kit Biflex ont des rigidités très similaires.

      Rosidal K et Rosidal Sys ont une rigidité plus élevée.

      Downloads Citation (RIS)
    4. Journal article

      Adjustable Compression Wraps (ACW) vs. Compression Bandaging (CB) in the Acute Phase of Breast Cancer-Related Arm Lymphedema Management-A Prospective Randomized Study

      Biology 2023 12(4)

      The objective of this study is to compare the effectiveness, comfort and possibilities of the self-application of adjustable compression wraps (ACW) with compression bandaging (CB) in the acute phase of treatment in advanced upper-limb lymphedema. In total, 36 patients who fulfilled the admission criteria were randomly assigned into ACW-Group (18 patients), or CB-Group (18 patients). Treatment in both groups lasted for two weeks. In the first, all patients were educated in applying adjustable compression wraps (ACW-Group) or self-bandaging (CB-Group) and treated by experienced physiotherapists. In the second week, the use of ACW and CB was continued by the patients themselves at home. In both groups, a clinically significant reduction in the affected limb volume was found after the first week (p < 0.001). A further decrease in the affected limb volume within the second week was noted only in the CB-Group (p = 0.02). A parallel trend was found in the percentage reduction in the excess volume after one and two weeks of compression therapy. Within two weeks, both groups achieved a significant improvement in decreasing lymphedema-related symptoms, but women from the ACW-Group reported complications related to carrying out compression more frequently (p = 0.002). ACW can reduce lymphedema and disease-related symptoms, but based on the results it is difficult to recommend this method as an alternative option in the acute phase of CPT among women with advanced arm lymphedema.

      Products Rosidal K
      PMID 37106735
    5. 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
      Downloads Citation (RIS)
      Further versions
    6. 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.

    7. Journal article

      Intrathorakale Unterdrucktherapie des Pleuraempyems unter Einsatz einer offenporigen Drainagefolie

      Chirurgie (Heidelberg, Germany) 2023 94(4) 349360

      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
    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) 859864

      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