Clinical Newsletter
Regular updates on our latest clinical studies.
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:
Duodenal suture insufficiency after surgical resection is difficult to treat. The method of active drainage of digestive secretions for anastomotic prophylaxis with simultaneous enteral nutrition is already used as a new safety concept in oesophageal surgery. It can also be used in duodenal surgery.
A thin Double lumen Open pore Film Drain (dOFD) is used for PINPT. The dOFD is constructed with a thin open-pore drainage film and a drain. The film consists out of two multi-perforated membranes separated by a small gap. When negative pressure is applied to the film, fluids can be aspirated over the entire surface of the space and through the numerous pores. By wrapping the film around the drain, small lumen Open pore Film Drainages (OFD) can be created.
After duodenal resection, the dOFD is placed intraluminal covering the anastomotic region. Vacuum is applied with an electronic negative pressure device. During wound healing duodenal secretions are kept away from the anastomosis. At the same time, the patient can be fed via an integrated feeding tube.
The innovative method of PINPT for anastomotic prophylaxis is demonstrated in a case report of duodenal resection for a large adenoma. PINPT lasted for 7 days. The anastomosis healed without complications.
OBJECTIVE
Pain induced by dressing removal is an important clinical problem in the management of acute wounds. Contact layer dressings are intended to protect the wound and minimise pain. This study was designed to compare two dressings of this type in terms of pain induced at the first dressing removal.
METHOD
Patients with acute wounds were randomly assigned to treatment with either an investigational product (n=78) or a comparator (n=81), and received treatment until their wound healed, or for a maximum period of 23 days.
RESULTS
By the first dressing change (day 3±2), minimal pain (<30mm on a 100mm visual analogue scale) was observed by 97.4% of patients in the intervention group and 97.5% of patients in the control group (modified intention-to-treat population (mITT)). For both mITT and per protocol populations, the lower bound of the unilateral 97.5% confidence interval did not exceed the prespecified -10.0% non-inferiority margin; thus, the non-inferiority of the investigational product to comparator was confirmed. In total, 64.8% of patients achieved wound healing by day 21±2. Time to wound closure, estimated for 50% of the patients using the Kaplan-Meier model, was 20±1.9 days for the intervention group and 19±2.7 days for the control group. The re-epithelialisation area doubled from baseline to day 21±2 in both groups. The opposite trend was observed for granulation, fibrin and necrosis areas. The number of periwound skin abnormalities significantly decreased in both groups. A good safety profile was demonstrated.
CONCLUSION
The results of this study showed that the investigational product supported healing and was non-inferior to the comparator in minimising dressing-associated pain in acute wounds.
Debridement is vital in wound bed preparation, creating a clean, moist environment that supports effective healing (Burnett et al, 2021). It facilitates the removal of devitalised tissue, bacteria, and debris, reducing infection risk and promoting healthy tissue growth (Mayer et al, 2024). Multiple debridement techniques exist such as sharp, larval, enzymatic, ultrasound, and surgical, however their use may be limited by required expertise or clinical setting. This article introduces an updated definition of debridement and traces its evolution from traditional methods to modern, patient-friendly technologies, exemplified by the innovative dual-sided monofilament pad, Debrisoft® Duo. It also includes some case series evaluating re the effectiveness and practicality of Debrisoft Duo, particularly in re managing wounds with persistent fibrous devitalised tissue where are conventional sharp debridement is unsuitable.
OBJECTIVE
Wound infections are a prevalent healthcare concern that can result in increased mortality and morbidity. It is imperative that antimicrobial-impregnated wound dressings are safe and consistently effective in preventing or treating infections and promoting wound healing. Data to this effect must be continually gathered by manufacturers during post market surveillance (PMS). This study aimed to gather relevant data about the quality, performance and safety of an antimicrobial HydroBalance biocellulose wound dressing, Suprasorb X+PHMB (polyhexamethylene biguanide) (BWD+PHMB), Lohmann & Rauscher International GmbH & Co. KG. Germany), under routine use.
METHOD
In this PMS, cross-sectional, retrospective study, data were obtained via online and paper questionnaires, completed by healthcare professionals.
RESULTS
A total of 61 healthcare professionals took part in the survey. The assessed parameters of the BWD+PHMB dressing were positively rated with regards to: intended purpose; indications; contraindications; wound types; performance; safety; and usability. Observed side-effects and additional comments were noted for potential future considerations.
CONCLUSION
Although prospective randomised controlled trials are beneficial and considered the scientific gold standard for real-time clinical data, surveys such as that carried out in this present study are less time-consuming, cost-effective, and provide sufficient data on the clinical use of wound dressings for PMS. The evaluated dressing in this study was reported as safe and effective. It was also confirmed that antimicrobial dressings should be used for treating infected wounds or wounds at risk of infection to support the wound healing process.
Postentzundliche oder postoperative Fisteln konnen die Lebensqualitat massiv einschranken. Im Fall eines 67-Jahrigen wird eine rektovesikale Fistel mittels Vakuumtherapie unter Nutzung einer offenporigen Foliendrainage behandelt. Ein Verfahren, das sehr wahrscheinlich zum ersten Mal bei Fisteln dieser Art zum Einsatz kam.