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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

    Hydrocolloid particles and petroleum jelly containing wound contact layer

    Wounds UK 2017 13(3) 8689

    For the management of wounds with no or low levels of exudate wound contact layers may be used. When combined with an absorbent dressing these dressings are also appropriate for use in moderate to highly exuding wounds. A wound contact layer that contains hydrocolloid particles and petroleum jelly coated onto a mesh was evaluated and compared to itself in a blinded-user test. Each dressing was split into two parts and then marked with four different colour tags. Usability (packaging, application, aseptic handling of the dressing, ease of dressing removal, conformability, flexibility, possibility to cut to size, adherence to the wound bed) and user acceptance (haptic, optic, easy to use) scored very good/good. There was no difference noted between the products tested. Although the features of the dressing that were evaluated were clinically relevant, the results need to be confirmed in actual wound management.

    Products Lomatuell Pro
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  2. Journal article

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

  3. 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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  4. 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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  5. Journal article

    In-vitro-assessment of fluid management by PU foam dressings under compression using a vertical maceration model

    Revue Francophone de Cicatrisation 2017 1(1) 75
    Products Suprasorb P
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  6. Journal article

    La cicatrisation: « une histoire d’eau » Suprasorb® X

    Revue Francophone de Cicatrisation 2017 1(1) 140
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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

    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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  9. Journal article

    Optimisation du temps et des techniques de détersion habituelles en structures hospitalières grâce à une compresse absorbante et fibreuse de détersion

    Revue Francophone de Cicatrisation 2017 1(1) 139

    Introduction :

    La détersion est une étape fondamentale dans l’induction du processus de cicatrisation(1). Dans le service cette étape est essentiellement réalisée à l’aide d’une curette ou d’un scalpel(2). Lors de notre consultation ces dernières posent souvent le problème de la tolérance par le patient, de la durée des soins, et de son efficacité selon l’opérateur.

     

    Objectifs :

    L’objectif de notre étude était d’évaluer l’intérêt d’une technologie fibreuse en pratique quotidienne de consultation de plaies chroniques.

     

    Matériels et méthodes :

    Cohorte constituée de 10 patients vus en consultations de suivi de plaies chroniques durant la période de septembre à octobre 2015. Chaque patient a bénéficié d’un débridement par Debrisoft® en remplacement du dispositif de détersion habituellement utilisé en consultation (curette métallique et scalpel). L’évaluation a été réalisée immédiatement à l’inclusion via une fiche de recueil comprenant : l’étiologie de la plaie ou de l’ulcère, la douleur avant, pendant et après les soins (Echelle Visuelle Analogique), le temps de débridement chronométré durant le soin et le ressenti du patient (Echelle de Likert de 1 à 5 en comparaison du dispositif de détersion habituel). Nous avons réalisé une photographie avant et après les soins.

     

    Résultats :

    Dix patients dont 6 femmes et 4 hommes ont été inclus durant une période de 3 semaines. Les soins ont tous été réalisés sans anesthésie ni antalgie, selon le protocole du service sans modification du pansement initialement prescrit (Hydrocellullaire, Alginate de Calcium ou Superobsorbant). La facilité, la qualité et la rapidité de débridement ont été appréciées par l’équipe soignante. Le temps moyen a été de 113 secondes par plaie. Le score de douleur est resté bas pendant la procédure (EVA moyennes = 2/3,3/2,5). Le ressenti du patient est globalement satisfaisant (Likert moyennes = 3,4).

     

    Conclusion :

    Cette technologie fournit une méthode rapide, facile et indolore de détersion. Le Debrisoft® a été jugé très utile par l’équipe soignante et nécessite un faible temps d’apprentissage. Ce dispositif de détersion a sans doute un intérêt dans la pratique des infirmières libérales et hospitalières qui prennent en charge des plaies chroniques. D’autres études avec un suivi prospectif doivent être effectuées pour confirmer ses effets bénéfiques sur la cicatrisation complète.

    Products Debrisoft Pad
  10. Journal article

    Endoscopic negative-pressure therapy for duodenal leakage using new open-pore film and polyurethane foam drains with the pull-through technique