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Clinical Newsletter

Regular updates on our latest clinical studies.

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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

    First Report of Intraluminal Endoscopic Negative Pressure Therapy (ENPT) for Anastomotic Prophylaxis in a Case of Tubular Resection of Cervical Esophagus

    Clinics in Surgery 2017 2 1500

    Introduction:

    Endoscopic Negative Pressure Therapy (ENPT) presents a novel treatment option for leaks in the upper gastrointestinum. We report a first use of intraluminal ENPT for intraoperative anastomotic prophylaxis in a case of high cervical tubular esophageal resection.

     

    Material and Method of Intraluminal ENPT:

    For intraluminal ENPT open-pore drainage is constructed by suturing open-pore polyurethane foam at the tip of a drainage tube. Then the drainage is placed in the esophageal lumen by endoscopic means. Negative pressure is applied with an electronic vacuum device. Esophageal lumen is occluded and drained by suction simultaneously.

     

    Case Report:

    A 46 year old woman underwent tubular resection of the upper esophagus because of a retroesophageal schwannoma. Cervical end-to-end esophago-esophagostomy anastomosis was hand sewn just below the upper esophageal sphincter. Then open-pore polyurethane foam drainage was placed intraluminal covering the whole anastomotic region and vacuum was applied.

     

    Results:

    Prophylactic ENPT ended after three days. Perfusion was excellent, no edema, ulceration or local inflammation were seen. Because of temporary left sided vocal cord paralyses artificial ventilation went on for one week postoperative. Endoscopy confirmed normal healing without stenosis in long term follow up.

     

    Conclusion:

    This first report is a single observation of the use of ENPT for intraoperative anastomotic prophylaxis. We suppose, prophylactic intraluminal ENPT might reduce the incidence of anastomotic leaks. Further studies are needed.

  2. Journal article

    Assessment of efficacy and tolerability of a new developed hydroactive wound dressing

    Revue Francophone de Cicatrisation 2017 1(1) 8081

    Aim:

    The efficacy of a wound dressing including effective exudate management and pain reduction, tolerability and user/patient satisfaction are the most important factors beside the treatment of the underlying disease. Therefore a clinical study with a new developed hydroactive wound dressing* was performed to evaluate the key factors of successful wound treatment in patients with chronic wounds.

     

    Methods:

    During an international, multicentre study data were collected regarding dressing performance (application, adaptability, shrinking, convenience, removability, improvement wound condition, wound edge protection, skin condition, exudate management) and rating of pain (VAS 0-10). Conclusion and general notes took place after an additional final visit.

     

    Results:

    64 patients (68 wounds: burns, leg ulcer, DFS, pressure ulcer, donor sites, other) existing since 0,5 – 31 months are included into the statistical evaluation. The wounds were superficial (77,4 %) and deep (22,6%) at the first visit. Infection was assessed in 18 % (n=12). Dressing performance (easiness of application, shrinkage of dressing, improvement of wound, wound edge, skin condition, uncomplicated use, reduction of maceration, would you use it again) was assessed in median with 1,51 (1=excellent, 2=very good). Regarding patient convenience (softness, non-adherence, removability in one piece), the hydroactive dressing was assessed in median with 1,74. Improvement of wound condition was confirmed in 95,2 %. Significant pain reduction was demonstrated (3,37 visit 1, 1,80 visit 4). Decrease of amount of exudate was also found (4,26 at visit 1, 2,85 at visit 4). The electronic evaluation (W.H.A.T.) showed a decrease of sloughy /necrotic tissue and an increase of granulation tissue. No safety-related reports have been served.

     

    Conclusion:

    The hydroactive dressing* showed clinical effectiveness and safety in a wide range of indications offering a noticeable facilitation in daily routine. Pain reduction and patient convenience leads to better quality of life and treatment satisfaction of the patient.

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  3. Journal article

    Mesures des pressions d’interface et calculs de la rigidité de 3 différents bandages: Conséquences pratiques

  4. Journal article

    Prevention of reflux after esophagectomy with endoscopic negative pressure therapy using a new double-lumen open-pore film drainage with an intestinal feeding tube

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  5. Journal article

    First report of urinary endoscopic vacuum therapy: For large bladder defect after abdomino-perineal excision of the rectum. Video paper

    Der Chirurg; Zeitschrift fur alle Gebiete der operativen Medizen 2017 88 4247

    PURPOSE

    The technique of active urinary endoscopic vacuum therapy (uEVT) is described. The surgical technique is demonstrated in detail with the help of a video of the operation, which is available online. Vesical fistulas are a rare complication following rectal surgery. The EVT technique is a novel method for the treatment of gastrointestinal leakage. This endoscopic procedure has been adapted to treat a large bladder defect after abdomino-perineal resection of the rectum with urine flowing out of the perineal wound.

     

    MATERIALS AND METHODS

    A new open-pore film drainage (OFD) catheter with an external diameter of only a few millimeters was developed and constructed from a very thin open-pore double-layered film and a drainage tube. The OFD was inserted into the bladder by means of flexible endoscopy and channeled out through a suprapubic incision. Continuous suction was applied with an electronic vacuum pump to actively drain the urine completely. A passive catheter drainage of urine from the renal pelvis via a transurethral single J stent was carried out simultaneously during the complete duration of treatment. The healing process was monitored during and after therapy via intravesical endoscopy.

     

    RESULTS

    The application of continuous negative pressure via the OFD resulted in total collapse of the bladder. The urine in the bladder was actively and permanently drained through the OFD. Urine leakage from the perineal wound stopped immediately after induction of suction. The bladder defect healed after 18 days of treatment with uEVT. After therapy and removal of the catheters, the patient had normal micturition.

     

    CONCLUSION

    A novel small-bore OFD was developed for EVT. The OFD technique allows for endoscopic application of negative pressure in the bladder. This first successful experience proves uEVT to be a potent interventional alternative in the treatment of bladder defects.

    PMID 27981372
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  6. Journal article

    Der Stifness-Booster: Vorstellung eines neuen Drei-Komponenten- Kompressions-verbandes mit maximalen Stiffness-Index

    Vasomed 2017 29(2) 7377

    Kleiner Ruhedruck und maximaler Arbeitsdruck sind das A und O für einen tiefenwirksamen Kompressionsverband. Dafür ausschlaggebend ist die Stiffness des Kompressionsmittels. Bisher hatte der nicht nachgiebige Zinkleimverband (Fischer-Verband) schon den höchsten Stiffness-lndex. Man konnte allerdings die Steifheit durch überwickeln mit Steifgaze (von Messpunkt B =direkt oberhalb des Knöchels bis D =zwei Querfinger unter Kniekehle) bei Bedarf noch steigern.

    Steifgazebinden werden leider seit Anfang 2016 nicht mehr hergestellt. Wir haben jetzt einen Ersatz gefunden, der überraschenderweise den Mehr-Komponenten- (Zinkleim, Steifgaze) Kompressionsverband in allen Bereichen übertrifft. Bei diesem neuen Mehr-Komponentenverband wird der nicht nachgiebige Zinkleim mit einer Gipsbinde (..Stiffness-Booster") von Messpunkt B bis D überwickelt und mit einer Idealbinde nach außen abgeschlossen. Zinkleim und Gipsbinde gehen eine ideale Symbiose ein mit dem Resultat eines maximalen Stiffness-lndex. Der Wirkungsgrad des neuen Verbandes ist um etwa ein Drittel höher als beim reinen Fischer-Verband. Er wird deswegen standardmäßig in meiner Ambulanz seit einem Jahr angewendet. Die Anlagetechnik und das Verbandmaterial für diesen Drei-Komponenten-Kompressionsverband werden vorgestellt.

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  7. Journal article

    Inelastic compression by bandages: effective, but requiring education

    Wounds International 2017 8(7) 69

    Based on experimental work, a practical definition of inelastic material is provided and some superior effects concerning an improvement of the venous haemodynamics are emphasised in this article. In contrast to elastic compression, this material can narrow the veins in the upright position and to exert beneficial haemodynamic effects by abolishing reflux and improving the venous pump. The main disadvantages are the fact that proper application is not easy and that these inelastic bandages lose pressure quickly. Most inelastic bandages are applied with a pressure that is too low. Training courses in which the sub-bandage pressure can be checked by adequate measuring instruments may improve this situation. Self-applied Velcro® devices where the pressure can be measured by the patient using simple measuring aids provided by some companies may be a valuable alternative. The patient feels which pressure is beneficial and can readjust the system whenever it is getting loose. Newly developed pumps are also of increasing interest.

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  8. Journal article

    Case series demonstrating the performance and safety of a novel superabsorbing dressing in high exuding chronic wounds – first results

    Revue Francophone de Cicatrisation 2017 1(1) 80

    Introduction

    Superabsorbent polymers based on polyacrylates have been used with great success in baby diapers and ladies’ hygiene products ever since the mid-1980s. They are also ideal for absorbing and retaining large amounts of liquids in wound dressings. The design of the marketed superabsorbent dressing was changed for a better ergonomic behavior, better application and due to another SAP core a higher absorption rate. The use of the new product on patients should be investigated during a case series.

     

    Method

    A case series was planned in 5 centers in Germany. The patients should be treated according to the instruction for use up to three weeks with the superabsorbent dressing. The products and a questionnaire with the parameters of interest as guidance for the investigators was provided. Documentation should be done every week. Thereafter the ergonomic behavior, performance and tolerability should be evaluated.

     

    Results

    Up to now 5 patients had been successfully treated (3 leg ulcer, 2 diabetic foot syndrome). In one patient suffering from diabetic foot syndrome with high exudation level, the wound shift was significant (start: 70% of fibrinous tissue and 30% of granulation tissue; after three weeks: 10% fibrinous tissue, 80 % granulation tissue and 10 % epithelization) indicating wound healing. Also the wound surrounding skin showed improvement. The patient was asked to assess the wound dressing revealing that the wound dressing was easy to apply, was comfortable, showed no pressure marks, and had a good absorption capacity. The user found that the dressing could be removed without damage of the wound ground. Exudation degree slightly decreased, no odour could be noticed and the dressing was easy to apply without causing folds. The second patient showed also improvement but did not show significant results due to lack of cooperation (did not wear off-loading shoes) after 3 weeks. Three patients suffering from leg ulcer were treated with the superabsorbent dressing as secondary dressing and a hydrofibre as primary dressing. All wounds showed reduced wound size and intact wound surrounding skin (also in one patient with atrophic skin) after three weeks of treatment. Dressing changes were performed once a day up three times a week.

     

    Summary

    The new designed superabsorbent dressing showed a good absorption capacity in high exuding wounds as leg ulcer and diabetic foot syndrome. In all cases the wound healing could be supported which could be confirmed by wound shift and reduced wound area. The patients found the dressing easy to apply, comfortable and had no complaints confirming the tolerability.

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  9. Journal article

    Comparatif médico-économique entre superabsorbant et hydrocellulaire adhésifs ou non

    Revue Francophone de Cicatrisation 2017 1(1) 136137
  10. Journal article

    An updated review of the evidence for adjustable compression wrap devices in the lower limb

    Nurse Prescribing 2017 15 613

    Compression therapy is a key component in the effective management of people with lower limb problems associated with venous, lymphatic and fat disorders such as lipoedema. Individuals with lymphoedema, venous ulceration and lipoedema often require long-term compression therapy to prevent and manage problems such as chronic ulceration and skin changes, persistent swelling and shape distortion. There are challenges in achieving acceptable, safe, effective and cost-efficient compression therapy choices. Adjustable, compression-wrap devices incorporating hook-and-loop systems present new opportunities for improving treatment outcomes, supporting patient independence and selfmanagement in the use of compression therapy.

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