I nostri team di ricerca e sviluppo sono distribuiti in tutto il mondo, generando sinergie grazie alle nostre competenze specializzate e discipline correlate. Partecipiamo a uno scambio internazionale con istituzioni specializzate indipendenti, opinion leader e moltiplicatori chiave, al fine di garantire la cooperazione e la gestione delle conoscenze ai massimi livelli. Come parte di questo impegno, conduciamo ricerche approfondite che vengono continuamente presentate ai congressi sotto forma di poster o conferenze dai nostri partner di cooperazione, nonché ai simposi e workshop, e pubblicati su riviste scientifiche rinomate. Le pubblicazioni specialistiche basate sulle evidenze, per lo più valutate da revisori indipendenti, sono disponibili in questo database:
Endoskopische Unterdrucktherapie : Vom Komplikationsmanagement zur präemptiven aktiven Refluxdrainage bei abdomino-thorakaler Ösophagusresektion – ein neues Sicherheitskonzept für die ÖsophaguschirurgieChirurgie (Heidelberg, Germany) 2023
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.
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.
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.
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.
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.
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 37882839
Complex physical therapy employing self-adjusting garment (ReadyWrap®) in breast cancer-related lymphedema cases in Brazilian women: a protocol for a randomized controlled trialTrials 2023 24(1) 549
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.
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.
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.
NCT04934098 [Clinical trials phase 1]. Registered on June 22, 2021. NCT04881604 [Clinical trials phase 2]. Registered on May 11, 2021.Products ReadyWrap Upper ExtremityPMID 37608354
Endoscopic negative pressure therapy for duodenal leaksFrontiers 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.
Intrathorakale Unterdrucktherapie des Pleuraempyems unter Einsatz einer offenporigen DrainagefolieChirurgie (Heidelberg, Germany) 2023 94(4) 349360
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.
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.
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.
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.
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.
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.
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.
Die OF kann als intrathorakales Drainageelement zur ITNPT bei Pleuraempyemen verwendet werden. Das Indikationsspektrum der Unterdrucktherapie erweitert sich um diese neue Anwendungsoption.PMID 36754892
Secondary wound closure with a new transparent negative-pressure dressingChirurgie 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.Further languages
Minimally invasive intrathoracic negative-pressure therapy and flexible thoracoscopy (FlexVATS) for patients with pleural empyemaScientific 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
Endoscopic vacuum therapy for esophageal perforation: a multicenter retrospective cohort studyEndoscopy 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
Adjustable Compression Wraps (ACW) vs. Compression Bandaging (CB) in the Acute Phase of Breast Cancer-Related Arm Lymphedema Management-A Prospective Randomized StudyBiology 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 KPMID 37106735
A real-world study of a calcium alginate dressing for various etiology wounds on clinical performance, usability, and safetyWounds 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 ProPMID 36877937Further versionsFurther languages
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.