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Clinical Newsletter

Regular updates on our latest clinical studies.

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Onze teams van Onderzoek en Ontwikkeling zijn wereldwijd werkzaam, en creëren synergieën met onze deskundigheid en verwante vakdisciplines. Wij wisselen internationaal veel van gedachten met onafhankelijke, gespecialiseerde instituten, belangrijke opinieleiders en kennisverspreiders om zo samenwerkings- en kennismanagement op het hoogste niveau te kunnen garanderen. In het kader daarvan voeren wij grote studies uit die voortdurend op congressen in de vorm van posters of lezingen van onze partners, op symposia en in workshops worden gepresenteerd, en ook in befaamde wetenschappelijke tijdschriften worden gepubliceerd. De voor het grootste deel door onafhankelijke deskundigen beoordeelde, op bewijs gebaseerde vakpublicaties stellen wij u graag in deze databank ter beschikking:

  1. Journal article

    Comparing the clinical performance of two selected mechanical wound debridement products in sloughy pressure ulcers

    Wounds Middle East Journal 2018 5 (1) 11 16

    Background:

    Mechanical wound debridement is an essential intervention in the treatment of slough pressure ulcers. Therefore, a lot of products are presented in the current local market as effective tools to perform that procedure. There is a need to revise the clinical performance of the available used products in one of the biggest governmental hospitals in Saudi Arabia to support efficient resource utilisation and suggest clinical practice protocols for pressure ulcer treatment.

     

    Objectives:

    The current retrospective cohort study compares the clinical performance of two products regarding mechanical debridement for sloughy sacral and heel pressure ulcer. Methods: The researchers retrospectively cohort the progress of 32 patients with more than 50% slough pressure ulcer, received mechanical debridement by wound care nurse during hospitalisation in the same setting and using the same pressure ulcer treatment protocols, by using either monofilament debridement pads (Debrisoft®; Lohmann and Rauscher) (16 patients) or mechanical debridement by using impregnated sterile gauze monofilaments (UCS™; WelCare Industries S.p.A) for a period of three continuous weeks. The research used PUSH tools as a data collection tool. The Hospital Institutional ReviewBoard approved the study.

     

    Results:

    Both products show the positive progress of pressure ulcer healing status after 3 weeks of application (P<0.01). Also, the progress mean among the monofilament group was significantly higher than the progress mean among the impregnated sterile gauze (P<0.05).

     

    Conclusion:

    The study recommends monofilament debridement pads for mechanical debridement on sloughy (more than 50% of wound bed) pressure ulcers.

    Products Debrisoft Pad
    URL
  2. Journal article

    A review of Debrisoft in the management of a variety of dermatological conditions.

    Dermatological Nursing 2018 17 (3) 33 39

    This product review examines Debrisoft utilising Monofilament Fibre Technology. Debrisoft is known for its ability to remove dry skin and for the removal debris and barriers to healing from acute and chronic wounds during a process known as wound bed preparation. Debrisoft has recently had its clinical indication extended to include dermatological conditions such as eczema and psoriasis.

  3. Journal article

    Handling properties of a superabsorbent dressing in the management of patients with moderate-to-very high exuding wounds

    Journal of wound care 2018 27 (4) 246 253

    OBJECTIVE

    Exudate control is an important aspect of wound management in both acute and chronic wounds. Exudate can be an indicator of the wound bed condition, specifically inflammation and infection. This study aimed to evaluate the performance, in terms of usability, handling properties, exudate management, user satisfaction and patient comfort, in daily clinical practice, of a superabsorbent dressing, Vliwasorb Pro (Lohmann & Rauscher), suitable for the management of moderate-to-very high exudate levels.

     

    METHOD

    The user test was conducted between September 2016 and July 2017, with clinicians from different specialisms in 55 centres across Germany. Both the dressing and user test were supplied by the sponsor. The superabsorbent dressing was used for at least three dressing changes, with frequency dependent on the patient and wound condition.

     

    RESULTS

    A total of 55 clinicians recruited 171 patients with various wound types. The clinicians rated dressing application as 'easy' for 163 (95.3%) of the patients. The dressing was rated as easy to remove (168 (98.3%) and, according to clinicians, did not soil patients' clothing in 165 (97.1%) of cases. The dressing demonstrated a 'good absorbent capacity', as noted by clinicians in 167 (98.2%) of cases. Clinicians also commented that the dressing reduced foul odour, maceration and improved periwound skin condition.

     

    CONCLUSION

    The evaluated dressing was easy to use, comfortable and reliable for patients with moderate-to-very high exuding wounds. In view of these results, superabsorbent dressings seem to be interesting for both clinicians and patients. Clinical studies are required to confirm these results.

    Products Vliwasorb Pro
    PMID 29637822
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  4. Journal article

    Improving the monofilament-fibre pad to debride wounds

    Wounds UK 2018 14 (4) 100 105

    Objective:

    In clinical studies, mechanical wound cleansing and debridement using a monofilament fibre product has been shown to be effective, and pain and traumafree.

     

    Methods:

    Two new monofilament fibre devices, both refinements of the existing Debrisoft pad, were created. The first added a pocket grip, and the second increased the size to 13 × 20 cm and retained the pocket grip. They were assessed in two acceptance evaluations.

     

    Results:

    The pads were assessed by 65 clinicians, split into two evaluations. The two new products with pocket grip was easy to handle, with a very good grip and hold. They fitted hands well, could be handled safely and were controlled and intuitive.

     

    Conclusions:

    The first product with the hand pocket met the design criteria (flexibility and stretchability of the pocket, softness and grip/hold, and easy handling). The larger pad met the design criteria regarding the fit of the pocket, safe and controlled use, and intuitive handling.

    Products Debrisoft Pad
    URL
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  5. Journal article

    Effectiveness of a monofilament wound debridement pad at removing biofilm and slough: Ex vivo and clinical performance

    Journal of wound care 2018 27 (2) 80 90

    OBJECTIVE

    Removal of slough and other devitalised tissue is an important step in biofilm-based wound care (BBWC) and wound bed preparation. Debridement is key to management of both slough and biofilm, and a number of methods are available to achieve this, including surgical/sharp and mechanical debridement. Developments have led to products indicated for debridement of wounds, including a sterile pad consisting of monofilament fibres. Our aim is to examine the effectiveness of a monofilament wound debridement pad (WDP), Debrisoft.

     

    METHOD

    We assessed the WDP, in laboratory tests, for the removal of mature biofilm from porcine dermal tissue in an ex vivo model, and the clinical management of sloughy wounds that would benefit from debridement. We used the UPPER score to determine the superficial infection status.

     

    RESULTS

    The WDP was effective in removing biofilm from porcine dermal tissue. A case series of 10 patients with chronic wounds suggested that the WDP was beneficial in the removal of slough. All chronic wounds had slough and were cleaned weekly, for four weeks, using the MDP to achieve improved healing and a clean wound bed. The average wound size decreased from 8.09cm2at baseline to 2.3cm2at week four, with three wounds healed completely. Exudate was reduced, and the UPPER score improved in every patient.

     

    CONCLUSION

    These results indicate that the WDP effectively debrides biofilm and slough, and contributes to care that follows the principles of wound bed preparation and BBWC.

    Products Debrisoft Pad
    PMID 29424644
    Further versions
  6. Journal article

    Nowa metoda leczenia i oczyszczania trudno gojących się ran

    Leczenie Ran 2018 14 (4) 145 148

    A chronic wound is a wound that is arrested in one of the wound healing stages for a certain amount of time and cannot progress further. Frequent debridement is required to remove necrotic tissue, foreign debris and biofilm bacteria which impair healing. In recent years different new debridement techniques have been introduced. A promising and effective technique is debridement with a monofilament debridement pad – Debrisoft. It is a modern wound-debridement tool, designed to mechanically remove slough and devitalized cells and bacteria from the wound. The aim of this paper is to present the applications of this tool.

    Products Debrisoft Pad
  7. Journal article

    Effect of graduated compression stockings on venous lower limb hemodynamics in healthy amateur runners

    Journal of vascular surgery. Venous and lymphatic disorders 2018 6 (1) 83 89

    OBJECTIVE

    The objective of this study was to analyze the effect of graduated compression stockings (GCS) on venous lower limb hemodynamics in healthy amateur runners.

    METHODS

    Ten runners were evaluated during rest and after a 10-km run without and with knee-high GCS of 20 to 30 mm Hg. Air plethysmography evaluated venous filling index (VFI), ejection fraction, and residual volume fraction (RVF) in both limbs. Capillary lactate level and heart rate were also measured.

    RESULTS

    Right VFI was 1.38 mL/s during rest, 1.98 mL/s without compression, and 1.32 mL/s with compression (P = .006). Left VFI was 1.35 mL/s during rest, 1.64 mL/s without compression, and 1.21 mL/s with compression (P = .006). In both limbs, ejection fraction was not different in the three situations. Right RVF was 22.35% during rest, 19.40% without compression, and 10.50% with compression (P = .006). Left RVF was similar in all situations. Capillary lactate level increased in runners without compression (P = .004) but kept stable in those wearing compression. The difference between after-run and before-run capillary lactate levels was similar in runners with and without compression. Rest, peak, and after-run heart rates were similar in runners with and without compression.

    CONCLUSIONS

    Healthy amateur runners had associated hemodynamic improvements when wearing knee-high GCS of 20 to 30 mm Hg during a 10-km treadmill run. VFI dropped in both limbs and RVF dropped at least in the right limb. There was no positive effect on calf muscle pump; capillary lactate variation; or rest, peak, and after-run heart rates.

    PMID 29126956
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  8. Journal article

    Anticoagulation and Desired Hemostyptic Properties of Abdominal Swabs during Surgical Interventions

    Surgical Research and Practice 2018 2 (1) 1 4

    In clinical routine, abdominal swabs are used to retain organs and tissues as well as to inhibit blood flow during surgical interventions. However, in patients receiving systemic anticoagulation treatment, the hemostyptic potency of the deployed abdominal swabs is likely to be influenced.

    To investigate this hypothesis, the simple clotting test (SCT) was used, in which abdominal swabs are incubated with fresh human whole blood for 30 min at 37 °C. Our data show that increasing heparin concentrations not only prolong the measured blood activated clotting time and the activated partial thromboplastin time prior SCT, but also prevent macroscopic blood clot formation as well as reduce platelet loss during SCT. However, the formation of the sensitive coagulation marker thrombin-antihrombin III still occurs even when using up to 2 IU/ml heparin.

    In conclusion, our data support the hypothesis that the hemostyptic potency of abdominal swabs are altered or even completely absent in patients receiving anticoagulation therapy.

  9. Journal article

    Endoscopic Negative Pressure Therapy (ENPT) of an Anastomotic Leakage after Total Gastrectomy with Open-Pore Polyurethane-Foam Drainages (OPD) and Open-Pore Film Drainage (OFD)

    Global Journal of Digestive Diseases 2018 4 (3) 8

    Introduction:

    Anastomotic leak is the most severe postoperative complication after total gastrectomy. Endoscopic negative pressure therapy (ENPT) in the upper gastrointestinum has been developed to treat transmural defects. For ENPT openpore polyurethane-foam drainages (OPD) and open-pore film drainages (OFD) can be used to apply intracorporal negative pressure. ENPT was used to treat an anastomotic leak after total gastrectomy in a 71 year old patient who underwent palliative total gastrectomy.

     

    Material and method:

    Intracavitary variant of ENPT started 25 days after initial gastrectomy with placement of an OPD through the anastomotic defect into the extraluminale cavity. Negative pressure of -125 mmHg was applied with an electronic vacuum device. Simultaneously the cavity was drained, and defect closed. Drain was changed regularly after 3-4 days. After shrunken to a small channel the last period of treatment was done with a small-bore open-pore OFD. For construction a very thin double layered open-pore film (Suprasorb CNP, Drainage Film; Lohmann & Rauscher International GmbH & Co. KG, Rengsdorf, Germany) was used.

     

    Results:

    Total time to treat the anastomotic leakage with ENPT (OPD and OFD) was 14 days. The anastomotic leak was closed completely only with ENPT. After starting the ENPT a laparotomy was performed because of peritonitis and an intraabdominal negative pressure therapy was applied after lavage of the abdominal cavity for 3 days. We also used the double layered open-pore film (Suprasorb CNP, Drainage Film; Lohmann & Rauscher International GmbH & Co. KG, Rengsdorf, Germany).

     

    Conclusion:

    ENPT is an innovative endoscopic method in the treatment of anastomotic leaks of the upper gastrointestium. Open-pore polyurethane- foam and small-bore open-pore film drainages can be used for the new endoscopic closure method for gastrointestinal defects. Compared to OPD one advantage of the novel OFD is its small diameter.

     

    Keywords:

    Endoscopic vacuum therapy; Esophagus; Anastomotic insuffizcieny; Peritionitis

  10. Journal article

    Inflammatory potential of cotton-based surgically invasive devices: Implications for cardiac surgery

    Journal of biomedical materials research. Part B, Applied biomaterials 2018 7 12

    Cotton-based surgical invasive devices with their desired hemostyptic properties have been used for decades in the surgical field. However, in cardiac surgery using the heart-lung machine with direct retransfusion of suction blood, activated blood may re-enter the circulation without filtration and may trigger a cascade reaction leading to systemic inflammation and thrombosis. We therefore set out to evaluate the inflammatory potential of untreated and pyrogen-impregnated cotton-based surgical invasive medical devices. After incubation of the swabs with whole blood or PBMC, the cell-free supernatant was investigated for IL1β and IL6. While the reaction of human whole blood toward cotton swabs could not be influenced by any sterilization technique, dry heat and gamma-irradiation were able to diminish the inflammatory reaction of PBMC toward the material and the used pyrogens. In conclusion, using PBMC in direct contact to cotton we are the first to establish a suitable test method for quantification of the pyrogenic/inflammatory activity of this material. The unaltered reaction of whole blood, however, suggests a crosstalk of cells and plasma proteins in the inflammation activation that is not prevented by sterilization of the swabs. This new in vitro testing methodology may help to better display the clinical situation during development of new materials. © 2018 Wiley Periodicals, Inc. J Biomed Mater Res B Part B: Appl Biomater, 2018.

    PMID 30467962