A core domain set for pyoderma gangrenosum trial outcomes: an international eDelphi and consensus study from the UPGRADE initiative.

BACKGROUND: Pyoderma gangrenosum (PG) is a rare ulcerative skin condition with no current standardized outcomes or outcome measures. With a rich investigational therapeutic pipeline, standardization of outcomes and improvement of data quality and interpretability will promote the appropriate and consistent evaluation of potential new therapies. Core outcome sets (COS) are agreed, standardized sets of outcomes that represent the minimum that should be measured and reported in all clinical trials of a specific condition. OBJECTIVES: To identify and reach a consensus on which domains (what to be measured) should be included in the Understanding Pyoderma Gangrenosum: Review and Analysis of Disease Effects (UPGRADE) core domain set for clinical trials in PG. METHODS: Collaborative discussions between patients and PG experts, and a systematic review of the literature identified items and prospective domains. A three-round international eDelphi exercise was performed to prioritize the domains and refine the provisional items (consensus: ≥ 70% of participants rating a domain as 'extremely important' and < 15% of participants voting 'not important'), followed by an international meeting to reach consensus on the core domain set (consensus: < 30% disagreement). Item-generation discussions and consensus meetings were hosted via online videoconferences. The eDelphi exercise and consensus voting were performed using Qualtrics survey software. Participants were adults with PG, healthcare professionals, researchers and industry representatives. RESULTS: Collaborative discussions and systematic reviews yielded 115 items, which were distilled into 15 prospective domains. The eDelphi exercise removed the three lowest-priority domains ('laboratory tests', 'treatment costs' and 'disease impact on family') and ranked 'pain', 'quality of life' and 'physical symptoms' as the highest-priority prospective domains. Consensus was reached on the domains of 'pain', 'quality of life' and 'clinical signs'. The domain of 'disease course/disease progression' narrowly failed to reach consensus for inclusion in the core set (32% of participants voted 'no'). Refinement of this domain definition will be required and presented for consideration at future consensus meetings. CONCLUSIONS: The UPGRADE core domain set for clinical trials in PG has been agreed by international multistakeholder consensus. Future work will develop and/or select outcome measurement instruments for these domains to establish a COS.

Diagnosis and treatment of venous leg ulcers: S2k Guideline of the German Society of Phlebology and Lymphology (DGPL) e.V.

This S2k guideline on venous leg ulcers was created on the initiative and under the leadership of the German Society of Phlebology and Lymphology (DGPL). The guideline group also consisted of representatives from the German Society for Phlebology and Lymphology, German Dermatological Society, German Society for General Medicine, German Society for Angiology, German Society for Vascular Surgery and Vascular Medicine, German Society for Surgery, German Society for Dermatosurgery, German Society for Wound Healing and Wound Treatment, Professional Association of Phlebologists and Lymphologists and Initiative Chronische Wunden. The aim of this guideline is to combine the different approaches and levels of knowledge of the respective professional groups on the basis of consensus, so that a basic concept for the best possible treatment of patients with venous leg ulcers can be provided. A total of 70 specific recommendations were formulated and agreed upon, divided into the subject areas of diagnostics, therapy, prevention of recurrences, and everyday challenges. The guideline thus reflects the current state of scientific knowledge and is intended to be widely used as the best available document for the treatment of patients with venous leg ulcers in everyday clinical practice.

How effective is simple mechanical wound debridement in reducing bacterial colonisation? Results of a prospective clinical study.

BACKGROUND AND AIMS: Bacteria in wounds can lead to stagnation of wound healing as well as to local or even systemic wound infections up to potentially lethal sepsis. Consequently, the bacterial load should be reduced as part of wound treatment. Therefore, the efficacy of simple mechanical wound debridement should be investigated in terms of reducing bacterial colonisation. PATIENTS AND METHODS: Patients with acute or chronic wounds were assessed for bacterial colonisation with a fluorescence camera before and after mechanical wound debridement with sterile cotton pads. If bacterial colonisation persisted, a second, targeted wound debridement was performed. RESULTS: A total of 151 patients, 68 (45.0%) men and 83 (55.0%) women were included in this study. The male mean age was 71.0 years and the female 65.1 years. By establishing a new analysis method for the image files, we could document that the bacterial colonised areas were distributed 21.9% on the wound surfaces, 60.5% on the wound edges (up to 0.5 cm) and 17.6% on the wound surroundings (up to 1.5 cm). One mechanical debridement achieved a significant reduction of bacterial colonised areas by an average of 29.6% in the wounds, 18.9% in the wound edges and 11.8% in the wound surroundings and was increased by performing it a second time. CONCLUSIONS: It has been shown that even a simple mechanical debridement with cotton pads can significantly reduce bacterial colonisation without relevant side effects. In particular, the wound edges were the areas that were often most contaminated with bacteria and should be included in the debridement with special attention. Since bacteria remain in wounds after mechanical debridement, it cannot replace antimicrobial therapy strategies, but offer a complementary strategy to improve wound care. Thus, it could be shown that simple mechanical debridement is effective in reducing bacterial load and should be integrated into a therapeutic approach to wounds whenever appropriate.

Aquacel Ag Advantage/Ag+ Extra and Cutimed Sorbact in the management of hard-to-heal wounds: a cohort study.

OBJECTIVE: To compare Aquacel Ag Advantage/Ag+ Extra (Aquacel Ag+) (Convatec, UK) and Cutimed Sorbact (Sorbact) (Essity, US) dressings indicated for the treatment of patients with venous leg ulcers (VLUs), diabetes foot ulcers (DFUs) and pressure injuries (PIs) for clinical performance and outcomes using real-world evidence in Germany and the US. METHOD: This study was a chart audit review of patients who used either Aquacel Ag+ or Sorbact dressings in the 24 months prior to October 2022. Healthcare providers with access to electronic medical records and charts were asked to capture data via patient record forms. The quantitative data were analysed. RESULTS: Findings in Germany were comparable between Aquacel Ag+ and Sorbact with regards to wound description, management and treatment outcomes, including percent area reduction and wound closure. A difference was that a greater proportion of Sorbact patients required surgery (0% versus 11%; p=0.039). In the US, a greater proportion of wounds were worsening before dressing in the Aquacel Ag+ cohort (49% versus 34%; p=0.010). A multinomial logistic regression yielded the result that patients who received Aquacel Ag+ were 3.53 times more likely to have the wound completely healed (p=0.033). CONCLUSION: Both Aquacel Ag+ and Sorbact dressings are widely used in Germany and the US for patients with VLUs, DFUs and PIs. Our study found two important differences: patients who used Aquacel Ag+ were less likely to need further surgery in Germany; and in the US, there were significantly higher odds that wounds would completely heal with Aquacel Ag+ dressings compared to Sorbact.

Compression therapy in dermatology.

Compression therapy is a conservative therapy that can be used in many patients with dermatological conditions, especially those associated with edema. In addition to its well-established use in venous and lymphatic disorders, there is increasing evidence that compression therapy supports the healing of inflammatory dermatoses. The presence of edema, regardless of its etiology, is an indication for the use of compression therapy. Nowadays, a variety of materials and treatment options are available for compression therapy, each with their own advantages and disadvantages. Often, compression therapy with low resting pressures is sufficient for effective therapy and is better tolerated by patients. The main contraindications to compression therapy are advanced peripheral arterial disease and decompensated heart failure. Individual factors and economic considerations should be taken into account when deciding on compression therapy with the patient. Patient self-management should be encouraged whenever possible. This requires education and support tools.

[Diagnostics and treatment of local wound infections]. / Diagnostik und Therapie lokaler Wundinfektionen.

Local wound infections are a multidisciplinary challenge which should be diagnosed as early as possible and adequately treated. In addition to a stagnation of wound healing, it is in particular the threat of development into systemic infections and even sepsis that represent feared, potentially life-threatening complications. This topic has a particularly high and multidisciplinary significance in the treatment of patients with chronic wounds. Until now, there were no generally accepted criteria for the diagnostics. The newly developed and validated TILI score, as a supplement to vital signs and serological values, enables rapid objectification of local wound infections. In addition, the W.A.R. score can be used to identify patients with an increased risk of infections. With these easy to use tools, the indications for antiseptic wound treatment can be assessed individually, quickly and without problems. For many patients with chronic wounds, polihexanide is then the wound antiseptic of first choice. However, the indications for wound antiseptics should be critically reviewed after a treatment duration of 14 days at the latest.

[Wounds caused by vasculitis-Current classification, diagnostics and treatment]. / Wunden durch Vaskulitiden ­ aktuelle Klassifikation, Diagnostik und Therapie.

Wounds of the skin can have very different causes. Especially in clinically atypical or non-healing wounds, the very heterogeneous group of vasculitides is of particularly important differential diagnostic significance. Nowadays, the classification of vasculitis is based on the affected vessels according to the Chapel Hill consensus conference. Thus, potentially any part of the vascular system can be affected. It becomes clear that there is often a risk of systemic diseases with high interdisciplinary relevance.Clinically, the usually very painful wounds in cutaneous vasculitis develop from necrosis and are typically surrounded by an erythematous-livid rim in the florid phase. In addition to clinical inspection, the histopathological examination of biopsies is of particular importance in the usually extensive diagnostic work-up.Therapeutically, adequate wound treatment should always be performed with a focus on pain prevention and infection prophylaxis. In the case of edema, compression therapy also supports wound healing. In addition, it is often necessary to initiate systemic treatment with immunosuppressive or immunomodulating drugs. Whenever possible, causally relevant factors and comorbidities should be diagnosed early and avoided or treated. Otherwise, there is a risk of severe or even fatal disease progression.

[Eczema of wound surroundings : Genesis, diagnostics and treatment]. / Ekzeme der Wundumgebung : Genese, Diagnostik und Therapie.

Skin changes in the surrounding areas of wounds are a frequently occurring multidisciplinary challenge in the care of patients with wounds, especially in older people. These are often inflammatory skin diseases like eczema that can be caused by various factors. These include allergens, noxa, incorrect skin care or prolonged contact with moisture. In the diagnostics, detailed medical history, clinical examination and allergological tests play important roles. Eczema can mostly be treated symptomatically with topical glucocorticoids. Calcineurin inhibitors are an alternative treatment, especially for longer term topical applications. In cases of impetiginized lesions, appropriate antimicrobial therapy should also be carried out. For long-term and preventive treatment the adequate use of skin care and skin protection products that help to strengthen or restore the skin barrier is decisive as well as the education of the patients and, if necessary, their relatives.

Predilection sites of pyoderma gangrenosum: Retrospective study of 170 clearly diagnosed patients.

Pyoderma gangrenosum (PG) is a non-infectious, neutrophilic dermatosis that was difficult to diagnose in clinical practice. Today, the PARACELSUS score is a validated tool for diagnostics. Based on this score, patients with clearly diagnosed PG were examined with regard to predilection sites. In this retrospective study, the data of patients from the University Hospitals of Essen and Erlangen were analysed in whom the diagnosis of PG could be clearly confirmed using the PARACELSUS score. A total of 170 patients, 49 men (29%) and 121 women (71%) with an average age at first manifestation of 55.5 years, could be included in the analysis. The predilection sites were identified as the lower legs in 80.6% of the patients and the extensor sides in 75.2%. Other localisations of PG were the thighs in 14.1%, mammae and abdomen in 10.0% each, back and gluteal in 7.1% each, feet in 5.9%, arms in 4.7%, genital in 3.5% and head in 2.9%. This retrospective study is the first to identify a collective of PG patients with the highest data quality using the PARACELSUS score. It could be shown that PG can basically occur on the entire integument. However, the predilection sites of PG, which have now been reliably identified for the first time, are the lower legs and in particular the extensor sides.

Inflammatory skin diseases and wounds.

Inflammatory wounds of the skin can be caused by many different diseases. Of particular importance here are the very heterogeneous groups of vasculitides and vasculopathies. These are usually interdisciplinary relevant diseases that require extensive diagnostics in specialized centres. Clinically, these inflammatory wounds present as very painful ulcers that develop from necrosis and are surrounded by erythematous livid borders. The healing process is often difficult and protracted. Moreover, it considerably impairs the quality of life of the affected patients. In addition to clinical evaluation, histopathological examination of biopsies taken as early as possible is particularly important in diagnosis. Numerous differential diagnoses must be ruled out. Therapeutically, in addition to the often necessary systemic therapies, which include immunosuppressants (immunomodulating drugs and/or rheologics), appropriate topical wound treatment, usually in combination with compression therapy, should always be considered. Whenever possible, the causative factors should be diagnosed early and avoided or treated.

Comorbidity and Therapeutic Approaches in Patients with Necrobiosis Lipoidica.

BACKGROUND: Necrobiosis lipoidica (NL) is a rare granulomatous disorder of unknown aetiology. Randomized controlled studies are not available due to it being an orphan disease. OBJECTIVES: We evaluated patients in 2 dermatological centres to cluster data about epidemiology, the therapeutic approaches for NL, and their efficacy. MATERIALS AND METHODS: Comorbidity and the efficacy of the applied treatment was assessed for 98 patients. RESULTS: We identified 54% of patients with concomitant diabetes and 19% with thyroidal disorders. Topical steroids (85.7%) were predominantly used followed by calcineurin inhibitors (31%) and phototherapy (41.8%). Systemically, fumaric acid esters were more frequently applied (26.8%) than steroids (24.4%) and dapsone (24.4%). Steroids, compression therapy, calcineurin inhibitors, phototherapy, fumaric acid esters, and dapsone showed remarkable efficacy. CONCLUSION: Therapeutic options were chosen individually in accordance with the severity of NL and presence of ulceration. Topical calcineurin inhibitors, systemic application of fumaric acid esters, and dapsone represent effective alternatives to the use of steroids.

Concurrent optical and magnetic stimulation therapy in patients with lower extremity hard-to-heal wounds.

OBJECTIVE: The treatment of patients with hard-to-heal wounds represents a major multidisciplinary challenge. Therefore, the development and clinical validation of new technologies remains extremely important. The novel application of concurrent optical and magnetic stimulation (COMS) offers a promising noninvasive approach to support physiological wound healing processes, especially in hard-to-heal wounds. METHOD: In a multicentre, prospective, comparative, clinical trial, patients with hard-to-heal wounds on lower extremities of different aetiologies were treated with COMS as an adjunct to standard of care (SOC). The primary endpoint was safety; secondary endpoints were wound healing, pain and wound-specific quality of life (Wound-QoL). RESULTS: A total of 40 patients were enrolled in this study (intention to treat population (ITTP), n=40). Of these patients, 37 were included in the analysis of the primary endpoint (primary endpoint population, (PEP), n=37). A further subgroup of 30 patients was included in the analysis of the secondary endpoint (secondary endpoint population (SEP), n=30). Finally, the SEP was stratified regarding patients' responsiveness to SOC in an SOC non-responder subgroup (NRSG), n=21, and in an SOC responder subgroup (RSG), n=9. A total of 102 adverse events (AEs) were recorded, of which 96% were 'mild' or 'moderate', and 91% were either a singular or transient event. Only 11 AEs were serious and associated with inpatient treatments unrelated to the studied intervention. In the NRSG, reductions in wound size were found to be statistically significant within the different study periods. Additionally, an acceleration of the healing rate was detected between the baseline and the first four weeks of COMS treatment (p=0.041). The rate of near-complete and complete wound closure in the SEP after 12 weeks were 60% and 43%, respectively. Pain reduction across the treatment group was statistically significant (p≤0.002 for both the SEP and NRSG). The Wound-QoL score improved by 24% during the study (p=0.001). CONCLUSION: In this study, COMS treatment for patients with hard-to-heal wounds on lower extremities was a safe and effective novel treatment option, especially for patients who did not respond to SOC.

Phlebological compression bandaging competence: comparing performance of nurses before and after one-off training.

OBJECTIVES: To investigate the differences in applying phlebological compression bandaging (PCB) in nurses before and after one-off training, and to compare the performance of subgroups. METHODS: Participants received training teaching the correct application of PCB. Participants' competence was measured using the newly developed control score of compression bandaging (CCB score) before and after training, one and three months later. Subgroup analyses compared participants (work setting, wound certification, PCBs applied per week). RESULTS: In total, 47 participants took part (mean age 40.7 years, 85.1% female, 59.6% outpatient nurses, 59.6% >10 years' working experience, 55.3% with a wound certificate). The CCB score improved after training. In all subgroups, the score differed significantly over time (p≤0.002 in all cases) except for participants applying the highest number of PCBs (p=0.241). In hospital-based participants, the CCB score three months after training was considerably, but non-significantly, higher than before training (2.84 versus 4.21, respectively; p=0.068). In participants working in outpatient settings, with and without a wound certificate, and applying a low (<5) and medium (5-10) number of PCBs per week, the CCB score remained significantly higher than before training (p≤0.011 in all cases). CONCLUSION: All subgroups benefited from training, mostly significantly, and maintained gains in competence for three months. Frequently applying these skills may improve performance. Previously published results showed that ideal pressure-related parameters are rarely achieved. Regular training should be offered, including the use of pressure-measuring devices, allowing nurses to gain experience and develop deeper understanding of correct PCB application.

TLC-Ag dressings: a prospective, multicentre study on 728 patients with wounds at risk of or with local infection.

OBJECTIVE: This study aimed to evaluate the management of an unselected cohort of patients with wounds at risk of or with clinical signs of local infection, treated with two antimicrobial contact layers impregnated with silver (TLC-Ag healing matrix), under real-life conditions during the COVID-19 pandemic. METHOD: A large, prospective, multicentre, observational study with two TLC-Ag dressings (UrgoTul Ag/Silver and UrgoTul Ag Lite Border, Laboratoires Urgo, France) was conducted in Germany between May 2020 and May 2021. The main outcomes included a description of the treated patients and their wound management, the changes in wound infection and wound healing outcomes over a maximum period of four weeks of treatment, as well as the overall clinical assessment of the performance, local tolerance and acceptability of dressings. RESULTS: A total of 728 patients with wounds of various aetiologies and wound infection status were treated with the evaluated dressings in 39 centres for a mean duration of 26±19 days, with an intermediate visit conducted in 712 (97.8%) patients after a mean period of 12±9 days. At the initial visit, it was established that the majority of patients (60.4%) had a wound infection, while the remaining cohort presented first clinical signs of a local wound infection (25.1%) or were at risk of wound infection (13.2%) (unclear status in 1.2%). Throughout the study period, all the parameters of wound infection continuously decreased, resulting at the final visit in a reduction by 78.9% of the prevalence of local wound infections and by 72.0% of the clinical signs of wound infection, the most rapidly diminished clinical sign being wound deterioration. Concurrently, in terms of the healing process, 92.1% of the wounds healed or improved, 3.2% remained unchanged and 1.7% worsened (data missing for 3.0%), and an improvement of the periwound skin was reported in 65.7% of the patients. Overall, the two dressings were 'very well accepted' by the majority of patients, with no uncomfortable feeling at wearing and no pain at dressing removal, and were assessed by the physicians as 'very useful' in the majority of the cases with a 'very good' efficacy in terms of antimicrobial activity and promotion of the wound healing process. Similar results were reported regardless of the wound type treated or of the TLC-Ag dressing evaluated. CONCLUSION: These results are consistent with previous clinical evidence on TLC-Ag dressings. They support the good efficacy, good tolerability and usefulness of these antimicrobial dressings in the management of patients with wounds at risk or with clinical signs of local infection, in association with appropriate standard of care.

A new compression system for treatment of venous leg ulcers: a prospective, single-arm, clinical trial (FREEDOM).

OBJECTIVE: To evaluate the efficacy, tolerability and acceptability of a new multicomponent compression system in one bandage for the local treatment of patients with venous leg ulcers (VLUs). METHOD: This was an international, prospective, non-comparative, clinical trial, conducted in France and Germany. Eligible participants had a VLU with a wound area of 2-20cm2, lasting for a maximum of 24 months. For a period of 6 weeks, patients were treated with a new multicomponent compression system in one bandage which was worn day and night, providing high working pressure and moderate resting pressure (UrgoK1). Clinical assessments, wound measurement and photographs were planned at weeks 1, 2, 4 and 6. The primary endpoint was the relative wound area reduction (RWAR) after 6 weeks of treatment. Secondary endpoints included wound closure rate, oedema resolution, change in patient's health-related quality of life (HRQoL), acceptability, adherence to the compression therapy, local tolerance, and physician's overall satisfaction with the evaluated compression system. RESULTS: A cohort of 52 patients (52% female, mean age 75.4±13.0 years) with VLUs, including oedema in 58% of cases, were recruited from 22 centres. At baseline, 42 patients had already been treated with a different compression system. VLUs had been present for 5.6±4.9 months and had a mean area of 5.7±4.3cm2. After 6 weeks of treatment, a median RWAR of 91% (interquartile range: 39.4; 100.0) was achieved. Wound closure was reported in 35% of patients. A RWAR ≥40% at week 4, predictive of wound healing at 12 weeks, was achieved in 62% of patients. At the final visit, oedema present at baseline was resolved in 57% of patients. Substantial improvements in the HRQoL of the patients were reported with a decrease of the pain/discomfort and anxiety/depression dimensions. Comfort in wearing the evaluated system was reported as 'very good' or 'good' by 79% of patients, resulting in a high patient adherence to compression therapy. Compared to previous compression systems, half of the patients reported more ease in wearing shoes, and greater satisfaction and comfort with this new system. Nine non-serious adverse events related to the device or its procedure occurred in seven patients. At the final visit, the majority of the physicians were 'very satisfied' or 'satisfied' with the new compression system overall. CONCLUSION: The new multicomponent compression system in one bandage has been shown to promote rapid healing of VLUs, reduce oedema, improve HRQoL and to be well tolerated and accepted. It appears to be a viable alternative to existing compression systems.

Impact of ovarian vein embolization in recurrent varicose veins of the lower extremity.

Background: The treatment success of catheter-based ovarian vein embolization due to peripheral varicose veins and ovarian vein reflux (OVR) should be investigated in this clinical investagtion. Patients and methods: For this study, 95 female patients were identified over a 5-year period (beginning of 2006 to end of 2011) after catheter-based coil (+/- chemical) embolization of the ovarian vein due to peripheral primary or recurrent varicose veins and proven reflux in the ovarian vein. Treatment success was retrospectively assessed in 2014 by means of a structured telephone interview (n=60), clinical examination (n=56), duplex ultrasound (n=56) and magnetic resonance imaging (n=51) in patients who were willing to participate in the study. Results: After an average of 51.9 months, 95.2% of the 60 included patients were diagnosed with recurrent varicose veins by duplex sonography and 88.1% by clinical examination. In 15.2%, a new intervention was required due to clinical symptoms. The median recurrence-free time was 47.0±5.5 months. A significant improvement by therapy was reported for all subjective symptoms in both pelvis and legs. No significant correlation between radiological findings and complaints or between radiological findings and clinical recurrence was found. Conclusions: The medical history of female patients with peripheral varicose veins should obligatorily include the question of symptoms in the pelvis. An appropriate diagnostic should follow in order to prevent a possible overlook of a pelvic leak point. Only then an individually adapted therapy for symptom relief is possible. Catheter-based ovarian vein embolization is one optional safe procedure that leads to significant improvement of subjective symptoms but does not necessarily prevent recurrent varicose veins.

[Position paper of the Initiative Chronische Wunde (ICW) e. V. on the nomenclature of debridement in chronic wounds]. / Positionspapier der Initiative Chronische Wunde (ICW) e. V. zur Nomenklatur des Débridements chronischer Wunden.

The nomenclature used today in wound treatment varies widely across different disciplines and professions. Therefore, it is a mission of the professional association Initiative Chronische Wunde (ICW) e. V. to exactly and comprehensibly describe terms that were previously unclear. Therefore, the experts of the ICW defined in a consensus procedure debridement of chronic wounds as the removal of adherent, dead tissue, scabs or foreign bodies from wounds. There are various therapy options for this, which can be differentiated into autolytic, biosurgical, mechanical, osmotic, proteolytic/enzymatic and technical debridement. In the case of surgical debridement, a distinction is also made between sharp debridements that can usually be performed on an outpatient basis, such as minor surgical procedures, and surgical debridements with adequate anaesthesia in an operating theatre. Wound irrigation is defined by the ICW as the removal of non-adherent components on wounds with sterile solutions. Debridement and/or wound irrigation are often the first step in phase-appropriate modern wound treatment. Several methods are suitable for use in a combined or successive therapy. When deciding which therapeutic option to use, a number of individually different factors should be taken into account, depending on the patients to be treated but also on the therapists. The final individual decision for a method should be made together with the patient in each case and then adequately documented.

The global impact of the COVID-19 pandemic on the management and course of chronic urticaria.

INTRODUCTION: The COVID-19 pandemic dramatically disrupts health care around the globe. The impact of the pandemic on chronic urticaria (CU) and its management are largely unknown. AIM: To understand how CU patients are affected by the COVID-19 pandemic; how specialists alter CU patient management; and the course of CU in patients with COVID-19. MATERIALS AND METHODS: Our cross-sectional, international, questionnaire-based, multicenter UCARE COVID-CU study assessed the impact of the pandemic on patient consultations, remote treatment, changes in medications, and clinical consequences. RESULTS: The COVID-19 pandemic severely impairs CU patient care, with less than 50% of the weekly numbers of patients treated as compared to before the pandemic. Reduced patient referrals and clinic hours were the major reasons. Almost half of responding UCARE physicians were involved in COVID-19 patient care, which negatively impacted on the care of urticaria patients. The rate of face-to-face consultations decreased by 62%, from 90% to less than half, whereas the rate of remote consultations increased by more than 600%, from one in 10 to more than two thirds. Cyclosporine and systemic corticosteroids, but not antihistamines or omalizumab, are used less during the pandemic. CU does not affect the course of COVID-19, but COVID-19 results in CU exacerbation in one of three patients, with higher rates in patients with severe COVID-19. CONCLUSIONS: The COVID-19 pandemic brings major changes and challenges for CU patients and their physicians. The long-term consequences of these changes, especially the increased use of remote consultations, require careful evaluation.

Increasing competence in compression therapy for venous leg ulcers through training and exercise measured by a newly developed score-Results of a randomised controlled intervention study.

Compression therapy with short-stretch bandages is the most common treating option for patients with venous leg ulcers in the decongestion phase in Germany. This randomised controlled intervention study examined whether a training is suitable to sustainably improve the skills of health care professionals. Altogether 55 nurses from hospitals and outpatient care participated. They were randomly assigned to case and control groups. Participants' abilities to properly apply a compression bandaging were assessed before and after a training session as well as after 1 and 3 months using a newly developed score (CCB score) based on six control parameters (CPs): padding, starting point, heel inclusion, heart direction, pressure at forefoot (A) and calf base (B1). After training, a significant increase in competence was observed, which only decreased non-significantly over the observation period: The average CCB score was 2.796 at V0, 4.89 at V1, 4.88 at V2, and 4.66 at V3. The CPs for pressure at A and B1 were met by a maximum of 42.6 and 43.6%, respectively, at all timepoints. The CP starting point was fulfilled by at least 61.7% after training, the CPs heart direction, heel and underpadding by at least 89.4, 96.4, and 97.9%, respectively. As a result of our study, it can be concluded that training improves the ability of users to apply compression bandagings, but one-off training does not appear to be suitable to improve the ability to apply compression bandagings with a therapy-relevant pressure. Therefor more training especially with pressure measuring devices would be necessary.

Effects of Patients' Expectation in Dermatology: Evidence from Experimental and Clinical Placebo Studies and Implications for Dermatologic Practice and Research.

Patients' expectations towards the benefit of a treatment are key determinants of placebo responses and can affect the development and course of medical conditions and the efficacy and tolerability of active medical treatment. The mechanisms mediating these placebo and nocebo effects have been best described in the field of experimental pain and placebo analgesia. However, also in dermatology experimental and clinical studies demonstrate that various skin diseases such as inflammatory dermatoses and allergic reactions can be modulated by patients' expectations. Dermatologists should consider the important modulatory role of patients' expectations on the efficacy and tolerability of specific treatments and the key role of verbal information, patients' prior treatment experiences (associative learning), and the quality and quantity of doctor-patient communication in shaping treatment expectation. As a consequence, techniques aiming at maximizing patients' expectation effects should be implemented into daily clinical routine. By contrast, in clinical studies expectation effects should be maximally controlled and harmonized to improve the "assay sensitivity" to detect new compounds. Further translational studies, also in dermatoses that have not been investigated yet, are needed to better characterize the mechanisms underlying patients' expectation and to gain further insights into potential clinical implications of these effects in dermatologic conditions. Therefore, in this review, we provide a brief overview on the concept of expectation effects on treatment outcome in general, summarize what is already known about this topic for dermatologic diseases, and finally present the relevance of this topic in clinical dermatology.