Local wound therapy for lower leg ulcers improved patient and user comfort

Transcription

1 Local wound therapy for lower leg ulcers improved patient and user comfort M. Schmitz 1, S. de Lange², M. Abel² 1 MCS Medical Consulting (Oberahr, Germany), ²Lohmann & Rauscher GmbH & Co. KG (Rengsdorf, Germany) Author s contact information: Michael Schmitz, MSc. MCS Medical Consulting Rotsteinerstr Oberahr/Deutschland info@mcs-schmitz.de The literature gives venous flow obstructions as the cause of a chronic wound healing disorder in up to 80% of all chronic ulcers on the lower leg depending on the publication 1. Therefore, venous flow obstruction is the most common cause of venous leg ulcers. A number of different factors play a central role in the treatment of lower leg ulcers. In addition to treatment of the underlying cause (chronic venous insufficiency CVI) by surgical methods and/or appropriate compression therapy 6, exudate management is an essential factor in terms of the creation of an environment which promotes wound healing and the prevention/avoidance of undesirable side effects such as maceration and drying out of the wound bed. The primary goal of local therapy is the creation and maintenance of a physiologically moist environment within the wound 1. The satisfaction of the patient is equally important to achieving and improving compliance with respect to the local therapy and causal therapy. The compliance of CVI patients has a positive effect on wound healing 2. Introduction The management of patients with chronic wounds is a considerable and challenging task. There is currently no standard therapy for chronic wounds 3. Different and to a certain extent contradictory approaches, a variety of different procedures and a considerable number of wound dressings result in confusion and uncertainty. Clinicians use a broad range of therapy options and products of different types and boasting varying degrees of patient and user comfort to treat chronic leg ulcers. As a result of this situation, there is a particular need for indication-appropriate materials and a solid understanding of the use of the same. When treating people with chronic wounds, in addition to treating the underlying cause and maintaining a physiological wound environment, patient comfort plays a central role. Pain relief is often top priority among patients, as the majority suffer from pain. Systematic reviews of the literature have shown that its impact on the daily lives of those affected turns out to be the most significant physical drawback 5. The focus of the person providing the treatment is prolonging dressing change intervals and effectively stimulating the wound healing process. The patient s compliance and his or her understanding of and about the condition are considerably dependent on this. The higher the patient s comfort, the higher his or her compliance. According to the World Health Organisation (WHO), only 50% of patients display good compliance on average 4. The performance of the hydroactive fibre dressing Suprasorb Liquacel as a component of a clinically effective and cost-effective wound treatment was assessed in a multicentre, international usage study. A key aspect of this study was an evaluation of usability, user satisfaction and patient satisfaction. Material and methods In a prospective application study spanning four visits, parameters were recorded documenting the wound dressing s performance (ease of use, adaptability, shrinkage, patient comfort, removability, improved wound condition, wound edge protection, skin condition and exudate management), and a pain assessment completed (NRS = numerical rating scale, 0-10). Following the final visit, a summarising conclusion and general remarks were recorded. Results 37 patients (male=20, female=17) with a total of 41 wounds were included in the study. The average age was years (min. 25, max. 93). The study included wounds of different pathogenesis (pressure ulcers, lower leg ulcers, surgical wounds, diabetic foot ulcers and others). 31 of the wounds were documented as being superficial and 10 as deep (see Diagram 1). The underlying pathogeneses were distributed as follows: 4 pressure ulcers, 17 lower leg ulcers, 3 diabetic foot ulcers, 11 surgical wounds and 7 wounds of other pathogenesis (see Diagram 2).

2 For the patient comfort category, the hydroactive fibre dressing was rated as excellent or very good on 94.4% of the surveys. In 94.6% of cases the improvement in the wound condition was rated as excellent, very good or good by the users (see Diagram 3). The patients confirmed a significant reduction in their pain (p=0.003, see Diagram 4). The electronic assessment tool (W.H.A.T) showed a reduction in the slough/necrosis from 79.94% of the wound surface (Visit 1) to 29.56% (Visit 4 or final visit if wound healed earlier) and an increase in the percentage of granulation tissue from 20.06% to 70.44%. Diagram 1: Wound depth Diagram 2: Wound pathogenesis Diagram 3: Patient comfort Diagram 4: Wound pain Case study 1: Fig. 1: Day 1 Fig. 2: Day 4 Fig. 3: Day year-old female patient who has had an ulcer for 2 months. Diseases: Chronic venous insufficiency, kidney failure, chron. arthritis and anaemia. The ulcer developed after bumping into the table edge. The ulcer measures 2.3 x 2.1 cm and there is a moderate level of exudation. The wound bed has a small quantity of fibrinous slough; there is visible granulation tissue. The wound margins are slightly macerated; wound pain was rated as 1 (NRS 0-10). Following cleansing of the wound with Ringer s solution and mechanical debridement with moistened dressings, Suprasorb Liquacel was applied up to and beyond the wound edges and a PU foam dressing used as a secondary dressing. Considerable improvement was already noticeable by Day 4. The fibrinous slough had reduced considerably; the granulation tissue was dark red and appeared to have a good blood supply. The

3 wound area had already shrunk slightly to 2.1 x 1.9 cm; the wound edge was free from maceration and was epithelizing. As time went on, the wound area continued to shrink and was covered by stable epithelial tissue by Day 44. Case study 2: Fig. 1: Day 1 Fig. 2: Day 7 Fig. 3: Day year-old female patient who has had an ulcer for 2 months. Diseases: Chronic venous insufficiency, hypothyroidism, bradyarrhythmia and anaemia. The two wound areas have a total surface area of cm 2 and there are moderate levels of exudation. The wound bed has a small quantity of fibrinous slough; there is visible pale granulation tissue. The wound edge appears dry; the wound is not painful. Following cleansing of the wound with Ringer s solution and mechanical debridement with moistened dressings, Suprasorb Liquacel was applied and a PU foam dressing used as a secondary dressing. Considerable improvement was already noticeable by Day 7. The fibrinous slough had reduced considerably; the granulation tissue was dark red and appeared to have a good blood supply. The wound area had already reduced considerably, the wound edge displayed no abnormalities and was epithelizing. As time went on, the wound area continued to shrink and was largely covered by stable epithelial tissue by Day 17. In the evaluation, special emphasis was placed on the following points in both cases: Continuous reduction in wound area, improvement in wound edge/wound environment, stimulation of granulation and epithelization, reduction in number of dressing changes, protection of wound edges and effective exudate management. Summary The results confirm the efficiency of the hydroactive fibre dressing both in terms of its clinical efficacy and patient comfort. No undesirable side effects were reported in either case.

4 The exudate management characteristics 7 already confirmed in vitro were also observed in vivo. The results indicate considerable relief in daily use. Pain reduction, improved skin condition and effective exudate management as well as high patient comfort improve both the quality of life and treatment satisfaction among patients and satisfaction among users. Reduced number of dressing changes, ease of use and easy removability also improve comfort for patients and users alike. Conclusion The following results were confirmed from the patients perspective for the studied primary dressing Suprasorb Liquacel: Excellent wound edge protection Reduced risk of maceration Very good skin condition Reduction/avoidance of pain Very high patient comfort The following advantages were observed for users: Reduction in the number of dressing changes Very good flexibility Excellent assessment of ease of use Very good removability (no adhesion to the wound, dressing can be removed in one piece) References: 1. S3-Leitlinie Lokaltherapie chronischer Wunden bei den Risiken CVI, PAVK und Diabetes mellitus. AWMF-Register Nr. 091/ Heinen M, Borm G, van der Vleuten C, Evers A, Oostendorp R, van Achterberg T. The Lively Legs self-management programme increased physical activity and reduced wound days in leg ulcer patients: Results from a randomized controlled trial. Int J Nurs Stud Epub 2011/10/ Wiltrud Probst, Anette Vasel-Biergans Wundmanagement, Ein illustrierter Leitfaden für Ärzte und Apotheker, , völlig neu bearbeitete und erweiterte Auflage, Wissenschaftliche Verlagsgesellschaft (ISBN) 4. ADHERENCE TO LONG-TERM THERAPIES: EVIDENCE FOR ACTION World Health Organization ISBN Deutsches Netzwerk für Qualitätsentwicklung in der Pflege (DNQP). Expertenstandard zur Pflege von Menschen mit chronischen Wunden. Osnabrück Leitlinien der Deutschen Gesellschaft für Phlebologie: Diagnostik und Therapie des Ulcus cruris venosum. AWMF-Leitlinien-Register Nr. 037/ K. Reddersen et al, In-vitro-analysis of the fluid management by hydroactive wound dressings using a maceration model. Poster 24th Conference of the European Wound Management Association (EWMA), May 2014, Madrid/Spain

5 Diagrams and tables: oberflächlich tief Diagram 1: Wound depth Wundpathogenese Dekubitus Ulcus cruris Operationswunde Diabetisches Fußulkus Andere Diagram 2: Wound pathogenesis Mittelwert gesamt Hautzustand Wundrandschutz Wundzustand verbessert Entfernbarkeit (Nichtverkleben) Patientenkomfort (Weichheit des Gels) Diagram 3: Patient comfort 4 Wundschmerz Wundschmerz 0 Visite 1 Visite 2 Visite 3 Visite 4 Diagram 4: Wound pain