Pyoderma Gangrenosum

The purpose of this study is to find out whether a medicine called spesolimab helps people with pyoderma gangrenosum (PG). The main aim is to see whether spesolimab leads to closure of PG ulcers. This study is open to adults with ulcerative PG with at least 1 ulcer that measures between 5 cm\^2 to 80 cm\^2 in size. This study has 2 parts. In Part 1, participants are put into groups randomly, which means by chance. 1 group gets spesolimab and the other group gets placebo. Placebo infusions look like spesolimab infusions, but do not contain any medicine. Every participant has a 2 in 3 chance of getting spesolimab. For the first 8 weeks, participants also take corticosteroid medicine by mouth. In Part 2, participants are put into groups again. Participants without open ulcers have an equal chance of getting spesolimab or placebo. Participants with open skin ulcers will get spesolimab. In both parts, participants receive spesolimab or placebo as an infusion into a vein every 4 weeks. Participants are in the study for about 1.5 years. During this time, they visit the study site 20 times. At study visits, doctors check the participant's skin for signs of PG. The doctors also regularly check participants' health and take note of any unwanted effects. The results of the groups are compared to see whether the treatment works.

Acutelines is a prospective biobank including patients with a broad spectrum of acute conditions. Its aim is to facilitate interdisciplinary research on the etiology and development of acute diseases with the aid of systematically collected biomaterials and medical data over various timepoints, both during the course of the patient's disease and after recovery. Clinical data, imaging data and biomaterial (i.e. blood, urine, feces, hair) are collected for patients presenting to the Emergency Department (ED) with a broad range of acute disease presentations. A deferred consent procedure (by proxy), is in place to allow collecting data and biomaterials prior to obtaining written consent. The digital infrastructure in place and the software used ensures automated capturing of all bed-side monitoring data (i.e. electrophysiological waveforms, vital parameters), and the secure importation of data from other sources, such as the electronic health records of the hospital, ambulance and general practitioner, municipal registration, health insurance companies and pharmacy. Follow up data are collected for all included patients during the first 72-hours of their hospitalization and 3-months, 1-year, 2-years and 5 years after their ED visit. Data and materials to be collected includes: * Demographic and health data (i.e. \[experiences\] health, quality of life, functional status) * Medical history (i.e. co-morbidity, intoxications, medication use) * Admission reason to emergency department * Physical examination and vital parameters * Clinical diagnostic data (i.e. \[point-of-care\] ultrasound, X-ray, CT-scan, laboratory results) * Electrophysiological waveforms (i.e. electrocardiogram \[ECG\], plethysmography) * Biomaterials * Treatment (i.e. medication use, non-pharmacological treatment, treatment decisions, length-of-stay in hospital, admission to intensive care unit \[ICU\])

Panton-Valentine Leukokidin and other toxins play an important role in the severity of skin and soft-tissue infections due to Staphylococcus aureus. The inhibition of the protein synthesis could be beneficial, due to the major role of protein-toxins in the pathogenesis of skin and soft tissue infections. Clindamycin has a strong toxin-suppressive activity. Therefore, clindamycin is currently considered as the most-promising adjuvant antimicrobial agent in the treatment of toxin-mediated S. aureus infections. Recurrent infections are common in patients with S. aureus skin and soft-tissue infections. Clindamycin has been reported to reduce S. aureus colonisation, which may in turn reduce the risk for recurrent infections. Clindamycin is an already approved antimicrobial used for a wide range of indications and with a known safety profile. This study is an investigator-led, investigator-initiated, open-label superiority randomised controlled trial that will be conducted at Masanga Hospital in Sierra Leone. The objectives of this study are to determine the feasibility, efficacy and safety of adjunctive clindamycin therapy (in addition to standard-of-care) compared to standard-of-care alone on clinical treatment outcomes in patients with skin and soft tissue infections due to S. aureus in Sierra Leone. This is a preliminary study, which will include 100 adult participants with skin and soft-tissue infections requiring systemic therapy.

Currently, surgery is a decisive therapeutic element in the management of women with breast cancer and at high risk for breast/ovarian cancer. In the first scenario, oncological surgery has evolved towards more complex technical procedures, such as oncoplastic surgery or skin-nipple-sparing mastectomies. These procedures have improved the quality of breast conservation or breast reconstruction, but have also increased the incidence of postoperative complications. In the second scenario, risk reduction mastectomies also share this same problem with an increase in adverse events after the use of ultra-conservative mastectomies. Without a doubt, skin necrosis is the most significant adverse event during the postoperative period in these patients due to three reasons. The first focuses on patients with breast cancer in whom skin necrosis delays the start of adjuvant treatments to surgery, chemotherapy or radiotherapy, causing greater complexity in their care process. Secondly, a significant number of these women with skin necrosis will require a second surgery to close the defect in the skin coverage, generally using a local flap, increasing care saturation and healthcare costs. Finally, these skin necrosis generate anatomical defects that in many cases will lead to cosmetic sequelae, worsening satisfaction and quality of life in this group of women. These consequences are especially relevant in women with prepectoral breast reconstruction, since the absence of muscle between the skin and the implant facilitates the exposure of the latter and, on occasions, the loss of the reconstruction. During the last 15 years our unit has published various articles analyzing adverse events during the postoperative period in patients with oncoplastic, reconstructive and risk reduction surgery. Thus, in a comparative study between lumpectomy and oncoplastic surgery in patients in our unit, an incidence of skin necrosis of 2.5% was demonstrated in oncoplastic procedures compared to 0.1% in lumpectomy. This higher incidence of complications had a significant impact on the delay for the start of radiotherapy, increasing this delay by 10 days compared to the group with lumpectomy. In the context of mastectomy, our unit has recently published the results of its prospective study PreQ 20 and it has shown an incidence of 5.6% of necrosis and skin dehiscence in women with skin-sparing mastectomy and breast cancer. Finally, another prospective study identified technical complexity and the appearance of postoperative complications as the two variables related to the appearance of cosmetic sequelae during follow-up in patients in our unit. These results highlight the value of prevention and/or early identification of skin ischemia to reduce the rate of necrosis during the postoperative period, guarantee delays during the care process, reduce cosmetic sequelae, and increase satisfaction and quality of life for women. with breast cancer and/or at high risk. Various studies have evaluated ICG angiography as a diagnostic method in mastectomy skin flap perfusion. To our knowledge, only two nonrandomized prospective studies have evaluated the sensitivity, specificity, and predictive values of this technique. The study by Phillips et al evaluated this procedure in 51 immediate reconstructions with expanders for the prediction of postoperative skin necrosis. Sensitivity, specificity, positive (PPV) and negative (NPV) predictive value were 90%, 50%, 56% and 88%, respectively. On the other hand, in the study by Munabi et al these values were 88%, 83%, 44% and 98%, respectively. In this latter study the authors found that smoking and epinephrine injection decreased the specificity of this diagnostic method from 98% to 83%. These studies have two limitations. The first refers to the fact that they have been performed in patients with a retropectoral breast reconstruction and through the use of expanders. Currently this type of reconstruction has been replaced by prepectoral reconstruction with direct implantation and for this reason we lack information on this new surgical modality. On the other hand, there are no studies that have evaluated ICG angiography in women with oncoplastic procedures. A Cochrane Library review was recently published whose objective was to evaluate the capacity of ICG angiography for the prevention of necrosis in mastectomy skin flaps in women undergoing immediate reconstruction after skin-sparing mastectomy. In this review we found nine studies that compared the number of postoperative complications in women undergoing ICG breast skin assessment versus clinical assessment. In these studies, a total of 1,589 women with 2,199 breast reconstructions were evaluated, and the number of complications per patient or per breast was reported. The main patient-related results of this review were that: * ICG can reduce reoperation rates. * there is uncertainty as to whether ICG decreases the rates of mammary skin necrosis, infection, hematoma and seroma. The main results referring to the breast were: * ICG can reduce mammary skin necrosis, reoperation rates and infection. * there is uncertainty as to whether ICG has an effect on hematoma and seroma rates. The evidence from the studies evaluated during this review is considered to be of very low quality as there are no prospective randomized studies. This review emphasizes the need for prospective studies to further investigate the use of the ICG in oncoplastic and reconstructive surgery of the breast. These uncertainties have encouraged us to carry out this prospective study in order to evaluate the role of indocyanine green angiography in the intraoperative identification of skin areas at risk for the appearance of necrosis in the skin cover of the breast in women operated on by an immediate oncoplastic or reconstructive procedure. Usually, when we talk about a diagnostic procedure such as ICG angiography, its sensitivity, specificity, positive predictive value, and negative predictive value are described. These parameters reflect the characteristics of the diagnostic test and serve to decide when they should be used (sensitivity and specificity of the test) or what is the meaning of this test in a particular patient. Unfortunately, the scientific literature has not evaluated these parameters for ICG angiography in the context of prepectoral reconstruction and oncoplastic surgery, which leads to empirical use of this procedure. The ultimate goal of this study is to provide information on the sensitivity, specificity, and predictive values of ICG angiography in these two clinical settings. With this, we intend to identify those patients in whom this diagnostic procedure provides added value in their surgical planning, reducing the incidence of skin necrosis and other associated surgical complications.

The origin of rare severe inflammatory skin diseases in dermatology is insufficiently known. They have in common the presence and activation of phagocytes, affect the quality of life through pain and inflammation and disfiguration, and can even be fatal. This study is intended to build on the findings that several of these neutrophil-mediated inflammatory dermatoses (NMID) have a genetic background and to identify rare, disease-causing mutations of several rare neutrophil dermatoses. This non-clinical case-control study is a research project with biological material and health-related data. To identify associations between NMID and variants in the genome next generation sequencing, mainly whole exome sequencing, will be used. In a second approach the expression level of already known inflammatory proteins in skin samples will be investigated. The data are obtained and verified using standardized methods as e.g. Nanostring, RNA sequencing and qRT-polymerase chain reaction (PCR), proteomics assays and immunohistochemistry as well as flow cytometry and imaging mass cytometry, ELISA, and Western Blot.

This is a Phase II study that will be open label and include a total of 17 patients who will receive the investigational product. PG will be defined by the investigator on the basis of results from clinical, histological and laboratory assessments. These patients will undergo 28 weeks of guselkumab dosed every 4 weeks and a stable dose of prednisone dosed daily with follow-up until week 40.

This multi-arm, multi-site study investigates the safety, tolerability, and efficacy of stem cell therapy for the treatment of various acute and chronic conditions. Clinically observed initial findings and an extensive body of research indicate regenerative treatments are both safe and effective for the treatment of multiple conditions. This study investigates clinical outcomes of treatments for numerous indications including: Autoimmune, Cardiovascular, Diabetes, Integumentary, Neurologic / Neurodegenerative, Pulmonary, Orthopedic Diseases, Sexual Dysfunction, Urologic Disorders and Viral Illnesses. Our hypotheses posit that regenerative treatments are both safe and statistically beneficial for a range of conditions. Outcomes will be determined by multiple valid outcome instruments that measure general quality of life information along with condition-specific information.

The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider.

After approved by the Ethics Committee of the Cancer Hospital of Zhejiang Province (Approval Number: IRB-2024-1037 (IIT)). This study was registered prior to patient admission. Written informed consent was obtained from all participants. The study is scheduled to run from November 25, 2024, to December 31, 2027. A total of 132 patients with ASA physical status I and III, undergoing thoracoscopic esophagectomy will be included. For patients in the liposomal bupivacaine group, in the left lateral decubitus position, a transversus paravertebral block (TPVB) is performed under ultrasound guidance at the right T4-T5, T7-T8, and bilateral T10-T11 paravertebral spaces, injecting 66.5mg (10 ml) liposomal bupivacaine into each space. Postoperative pain control involves patient-controlled intravenous analgesia (PCIA) with 250 μg sufentanil diluted to a total of 250 ml volume with saline. Background dose of 2-3 mL/h, PCA bolus of 2-4 mL depending on height and weight, lockout interval of 15 minutes, and a maximum dose of 10-15 mL.For the standard control group, a T6-T8 epidural block is administered, with 4-6 mL of 0.25% bupivacaine was applied depend on the height and weight. Postoperative analgesia is managed with patient-controlled epidural analgesia (PCEA), with 141 μg sufentanil and 300 mg bupivacaine hydrochloride diluted to 250 mL. Background dose of 3-6 mL/h, PCA bolus of 3-4 mL, lockout interval of 15 minutes, and a maximum dose of 20 mL. When a participant's resting VAS score is ≥4 and they request additional pain relief, the first rescue analgesic is a single intravenous dose of acetaminophen or an NSAID (flurbiprofen axetil, 50 mg). For a second rescue, a single intravenous dose of 100 mg tramadol is administered. Additionally, the APS team adjusts the background and bolus doses based on pain relief assessments from the previous 24 hours.

Platelet rich fibrin (PRF) is a new therapy option for chronic wounds with yet unproven therapeutic efficacy. This randomised controlled trial aims to provide evidence of the efficacy of PRF as monotherapy as well as a growth promoting carrier matrix for antimicrobial compounds. The investigators therefore designed a four armed trial with three PRF arms which are compared to each other as well as to an active comparator. The treatment arms are as follows: Study arm 1: PRF with amikacin and teicoplanin Study arm 2: PRF with placebo (0.9% sodium chloride) Study arm 3: PRF with PHMB (polyhexanid) plus Macrogolol (Lavasorb®) Study arm 4: Acticoat 7® wound dressing as active control Patients with infected chronic wounds may be included in this trial. Infection shall be diagnosed by an experienced senior infectious diseases specialist. Patients with untreated peripheral vascular occlusive disease as defined by an ABI (ancle brachial index) of \< 0,7 are excluded from the trial as are patients with an uncontrolled diabetes mellitus or patients who have not received sufficient treatment for a diabetic foot syndrome. Any underlying illness will be treated following standard of care. In case of chronic venous insufficiency four-layered compression bandages will be applied each visit if tolerated by the patient. Alternatively compression stockings (Class III) are permitted. This is mentioned as "Disease specific treatment" in the protocol. Patients will receive treatment for 56 days. After 28 and 56 days the wound surface will be compared to the baseline. Infection parameters (c-reactive protein and leucocyte count) will be measured weekly. Evaluation of systemic antimicrobial therapy will be performed at each visit. Systemic antimicrobial therapy is started at the discretion of a senior infectious diseases specialist.