Clinical Newsletter
Regular updates on our latest clinical studies.
Nuestros equipos de investigación y desarrollo operan a nivel global y generan sinergias desde nuestra experiencia colectiva y a partir de disciplinas relacionadas. Del mismo modo estamos intercambiando información constantemente a nivel internacional con instituciones técnicas independientes, importantes líderes y multiplicadores de opinión para poder garantizar una gestión de la cooperación y del conocimiento al más alto nivel. Como parte de este proceso, también llevamos a cabo una investigación exhaustiva, cuyos resultados presentamos continuamente en workshops, conferencias y simposios - tanto en forma de documentación gratuita, como en ponencias ofrecidas por nuestros socios cooperadores - así como publicaciones en prensa científica de renombre. Esta base de datos contiene un largo número de estos artículos basados en evidencias científicas, cuya mayoría ha sido evaluada por asesores independientes:
Fifty-two patients (26 in each group) were recruited into this randomized, comparative, controlled trial of Rosidal K short-stretch compression bandage and SurePress long-stretch compression bandage in the treatment of venous leg ulcers. Patients were monitored for a maximum of 12 weeks. Each patient was seen weekly by a research nurse, who recorded the study variables. The mean percentage reduction in the wound bed surface area during the study period was 52% in the SurePress group and 73% in the Rosidal K group. Eight patients in each group saw their ulcers heal within the study period. The average limb volume reduction, based on the first 4 weeks of data collection, was 2.3 cm for those in the Rosidal K group and 3.9 cm in the SurePress group. Ulcer size increased in six patients allocated to SurePress bandages and in four patients allocated to Rosidal K bandages.
This trial was undertaken to examine the safety and efficacy of four-layer compared with short stretch compression bandages for the treatment of venous leg ulcers within the confines of a prospective, randomised, ethically approved trial. Fifty-three patients were recruited from a dedicated venous ulcer assessment clinic and their individual ulcerated limbs were randomised to receive either a four-layer bandage (FLB)(n = 32) or a short stretch bandage (SSB)(n = 32). The endpoint was a completely healed ulcer. However, if after 12 weeks of compression therapy no healing had been achieved, that limb was withdrawn from the study and deemed to have failed to heal with the prescribed bandage. Leg volume was measured using the multiple disc model at the first bandaging visit, 4 weeks later, and on ulcer healing. Complications arising during the study were recorded. Data from all limbs were analysed on an intention to treat basis; thus the three limbs not completing the protocol were included in the analysis. Of the 53 patients, 50 completed the protocol. At 1 year the healing rate was FLB 55% and SSB 57% (chi 2 = 0.0, df = 1, P = 1.0). Limbs in the FLB arm of the study sustained one minor complication, whereas SSB limbs sustained four significant complications. Leg volumes reduced significantly after 4 weeks of compression, but subsequent volume changes were insignificant. Ulcer healing rates were not influenced by the presence of deep venous reflux, post-thrombotic deep vein changes nor by ulcer duration. Although larger ulcers took longer to heal, the overall healing rates for large (> 10 cm2) and small (10 cm2 or less) ulcers were comparable. Four-layer and short stretch bandages were equally efficacious in healing venous ulcers independent of pattern of venous reflux, ulcer area or duration. FLB limbs sustained fewer complications than SSB.
Die Kompressionstherapie bleibt eine entscheidende Säule der Phlebologie. Der therapeutische Zentralsatz lautet: Heilphase mit nicht nachgiebigen Verbänden -Erhaltungsphase mit elastischem Material (Kompressionsstrumpf). Indikationen, Anlagetechnik und das Verbandmaterial für den ein-fachsten der »Fischer-Verbände«, den Druckverband, wird aufgezeigt. Dieser kann vom Patienten nach Anleitung selbst gewickelt werden.
Die ambulante Therapie der tiefen Beinvenenthrombose erlebt eine Renaissance. Durchgeführt wird sie mit Kompressionsverbänden nach Heinrich Fischer. DieTechnik und das Material für den nicht nachgiebigen und den nachgiebigen fixierten Unterschenkel-Kompressionsverband werden vorgestellt.
Aim: Addressing the challenge of infected or infection-prone wounds in wound care, a new antimicrobial calcium alginate dressing was developed. This study aims to evaluate the dressing's performance, safety, and ease of use in treating such wounds.
Method: The clinical study occurred at 5 German centers, treating 91 patients (46% male/54% female) with the investigated product. They followed instructions for at least 4 dressing changes over 7 to 28 days. Data was collected via an electronic questionnaire, with an average patient age of 69.46 ± 16.38 years.
Results / Discussion: The study included patients with various conditions (e.g., leg ulcers, postoperative wounds, pressure injuries, diabetic ulcers, arterial ulcers, and skin graft or donor sites. Among these, 42% were deep, and 58% superficial. Infection indicators decreased by 1.34 on the Visual Analog Scale. Practitioners achieved treatment goals at a 94% success rate, addressing moisture, debridement, wound edge protection, healing support, exudate management, infection control, prevention, and bleeding. The examined dressing had a 7.7% gel failure rate, maintaining 98.9% coverage. It efficiently removed debris in 97%, conformed to the wound in 98.9%, with 1.1% maceration. Exudate channeled into the secondary dressing in 97.2%. Dressing removal was in one piece in 97.8%, with 10.99% easily removable fibre residues. Adherence to the wound bed was 4.4%. Dressing changes were atraumatic in 97.8%, and 100% found ease of use, including cutting when dry, as very easy or easy.
Conclusion: The study confirmed the new wound dressing's excellent effectiveness in handling infected or infection-prone wounds.
Aim: Addressing the challenge of infected or infection-prone wounds in wound care, a new antimicrobial hydro-active fibre dressing with silver nanoparticles was developed. This study aims to evaluate the product's performance, safety, and usability in managing such wounds.
Method: The clinical study was conducted at 6 centers in Germany and Austria. Eight wound managers treated 81 patients using the investigated product, performing at least 4 dressing changes over 7 to 28 days as instructed. Data was collected through an electronic questionnaire, and patients' average age was 66.88 ± 16.17 years.
Results / Discussion: The study included patients with various conditions (e.g., leg ulcers, postoperative wounds, burns, injuries, diabetic ulcers, traumatic wounds, bleeding-prone wounds). Of these, 41% were deep and 59% superficial. Exudation was moderate in 75% and high in 25%. Infection signs decreased by 2.64 on the Visual Analog Scale. Biofilm disappeared in 60%, partially in 31%. Practitioners achieved treatment goals at 95.3%, ensuring moisture, debridement, edge protection, healing support, exudate management, infection control, and prevention. The dressing removed debris in 100%, conformed in 98.8%, had gelation issues in 3.7%, and exudate spread in 26%. Maceration occurred in 2.5%. Exudate was directed into the secondary dressing in all cases. Intact removal was 100%, with 12.4% easily removable fibre residues. Adherence to the wound bed was in 5%. Atraumatic dressing changes occurred in all cases, and the dressing could be cut for every wound.
Conclusion: The study showed the new wound dressing is effective for managing infected or infection-prone wounds.
Aviso COFEPRIS 183300202C1039
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