[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"necrotizing-soft-tissue-infection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:necrotizing-soft-tissue-infection":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,48,70,108,139],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100630561","phase-4-adjunctive-hyperbaric-oxygen-treatment-for-patients-with-necrotizing-soft-tissue-infection-hot-nsti-trial-100630561",false,"NCT07489274","Adjunctive Hyperbaric Oxygen Treatment for Patients With Necrotizing Soft-Tissue Infection (HOT-NSTI Trial).","Adjunctive Hyperbaric Oxygen Treatment for Patients With Necrotizing Soft-Tissue Infection (HOT-NSTI Trial)","HOT-NSTI","Inclusion Criteria:\n\n* Adults (age ≥18 years)\n* Surgical confirmed NSTI (defined by perioperative tissue characteristics observed by the surgeon. The diagnosis is based on sign as necrotic or deliquescent soft tissue with widespread undermining of the surrounding tissue)\n\nExclusion Criteria:\n\n* Contraindications for HBO2 treatment according to local protocol (e.g., undrained pneumothorax)\n* Confirmed pregnancy\n* Referred to palliative care\n* Previously randomized into the HOT-NSTI trial\n* Known objection by the patient to participate in the trial\n* Allergy against study drug","ALL","18 Years",{"count":20,"type":21},1480,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","Necrotizing soft-tissue infection (NSTI) is a rare, severe, fast-progressing bacterial infection within the soft tissue compartment. The NSTI mortality rate remain high and largely unaltered in the last decades. The standard of care in NSTI is multidisciplinary and includes surgery, intensive care, and broad-spectrum antibiotics. Hyperbaric oxygen (HBO2) treatment is an adjunctive treatment potentially improving survival, but is not standard of care in many centres, presumably as no evidence of its benefit from randomized clinical trial exists.\n\nThe primary objective of this trial, HOT-NSTI, is to investigate the effect of adjunctive HBO2 treatment on 30-day all-cause mortality in patients with NSTI.",[27],"Necrotizing Soft Tissue Infection",[29,30,31,32,33,34],"NSTI","Sepsis","clinical trial","Hyperbaric Oxygen Treatment","Hyperbaric Oxygen Therapy","Necrotizing soft tissue infection","RECRUITING","2026-04-24",{"date":38,"type":39},"2026-04-30","ACTUAL",{"date":41,"type":39},"2026-04-04",{"date":43,"type":21},"2033-06-30",{"name":45,"class":46},"Ole Hyldegaard","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":47},"100582007","the-management-of-necrotizing-soft-tissue-infection-wounds-with-cytal-wound-matrix-and-micromatrix-100582007","NCT06857708","The Management of Necrotizing Soft Tissue Infection Wounds With Cytal® Wound Matrix and MicroMatrix®","Inclusion Criteria:\n\n1. Adults (≥ 18 years) with a diagnosis of necrotizing fasciitis\n2. Wound ≥ 30 cm2\n3. The participant is willing and able to adhere to protocol requirements and agrees to participate in the study program and comply with the study follow-up regimen.\n\nExclusion Criteria:\n\n1. Burn as etiology of wound\n2. Acute osteomyelitis requiring active treatment\n3. Known allergy, hypersensitivity, or objection to porcine materials\n4. Pregnant participants\n5. Lack of English language fluency\n6. Participant report of concurrent participation in another clinical trial that would interfere with this study\n7. Inability to consent",{"count":55,"type":21},50,[57],"NA","This is a prospective, pilot, parallel group, randomized controlled trial with 1:1 allocation. This will be a single center study coordinated at the Cleveland Clinic Foundation (CCF) Main Campus in Cleveland, Ohio. Data will be collected in a secure manner using REDCap housed at CCF. The study will consist of 2 arms: treatment with Cytal® Wound Matrix 2-Layer and MicroMatrix® (Integra LifeSciences, Plainsboro Township, NJ, U.S.A.) versus standard of care dressings. Wound debridement procedures will be performed by surgical staff at CCF. A co-investigator trained in the application of Cytal® Wound Matrix and MicroMatrix® will apply these treatments as outlined in section 6.1.2 Administration. This study will be conducted with IRB approval and written informed consent of each participant enrolled. The trial will be registered at ClinicalTrials.gov before the first participant is enrolled.",[60,27],"Necrotizing Fascitis","2026-03-30",{"date":63,"type":39},"2026-04-03",{"date":65,"type":39},"2025-03-05",{"date":67,"type":21},"2026-12-31",{"name":69,"class":46},"Benjamin T. Miller",{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":78,"targetDuration":80,"studyType":81,"phases":4,"briefSummary":82,"conditions":83,"keywords":90,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":107},"100458003","myriad-augmented-soft-tissue-reconstruction-registry-100458003","NCT05243966","Myriad™ Augmented Soft Tissue Reconstruction Registry","Registry of Myriad™ Utilization in Soft Tissue Reconstruction Procedures","MASTRR","Inclusion Criteria:\n\n* Willing and able to provide written informed consent and to comply with the requirements of Clinical Investigational Plan\n* Male or female patients aged 18 years or above\n* Patients where Matrix and\u002For Morcells were used as part of their soft tissue reconstruction procedure\n* Subject that are willing and able to comply with all aspects of the treatment and evaluation schedule\n\nExclusion Criteria:\n\n* Patients with known sensitivity to ovine (sheep) derived material\n* Patients with full thickness ('third degree') burns\n* Patients with wounds with uncontrolled clinical infection (CDC Contamination Grade=4)\n* Any medical condition or serious intercurrent illness that, in the opinion of the investigator, may make it undesirable for the patient to participate in the study\n* Patient is currently participating or has participated in another clinical study within past 30 days prior to enrollment\n* Pregnant or lactating women\n* Any subject who, at the discretion of the Investigator, is not suitable for inclusion in the study",{"count":79,"type":21},800,"12 Months","OBSERVATIONAL","This is an observational study designed to evaluate the safety and clinical outcomes of Myriad™ in soft tissue reconstruction procedures. The study will enroll participants who are undergoing a surgical procedure, where the attending physician will use Myriad™ as part of the surgical intervention.",[84,27,85,86,87,88,89],"Abdominal Wound Dehiscence","Lower Extremity Wound","Pilonidal Sinus","Anal Fistula","Hidradenitis Suppurativa","Pressure Injury",[91,92,93,94,95,96],"Soft tissue reconstruction","Limb salvage","Extracellular matrix","Soft tissue reinforcement","Wound reconstruction","Regenerative medicine","2026-02-17",{"date":99,"type":39},"2026-02-19",{"date":101,"type":39},"2022-01-10",{"date":103,"type":21},"2029-01",{"name":105,"class":106},"Aroa Biosurgery Limited","INDUSTRY",13,{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":115,"enrollmentInfo":116,"targetDuration":4,"studyType":22,"phases":118,"briefSummary":119,"conditions":120,"keywords":124,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":137,"locationsCount":47},"100322771","the-role-of-circadian-clock-proteins-in-innate-and-adaptive-immunity-100322771","NCT03482245","The Role of Circadian Clock Proteins in Innate and Adaptive Immunity","Light Therapy in Patients Undergoing an Operation for a Septic Joint, Necrotizing Soft Tissue Infection, Intraabdominal Sepsis, or Medical Treatment of Pneumonia","Inclusion Criteria:\n\n* greater than or equal to 18 years of age and less than or equal to 65 years of age\n* one of the following diagnoses requiring inpatient hospital care\n\n  1. an operation for intraabdominal infection\n  2. an operation for necrotizing soft tissue infection\n  3. an operation for an infected joint\n  4. medical treatment of pneumonia.\n\nExclusion Criteria:\n\n* traumatic brain injury\n* blindness\n* immunocompromised or immunosuppressed state\n* infection requiring treatment in preceding 30 days\n* blindness\n* SARS-CoV-2","65 Years",{"count":117,"type":21},144,[57],"Our data suggest that modulating the characteristics of light carries the potential to modify the host response to injury and critical illness and thus, improve outcome. The ability to modify the host response to the stress of major operations and sepsis carries immense potential to improve patient care.\n\nThe primary purpose of this study is to determine if exposure to bright blue (442nm) enriched light, by comparison to ambient white fluorescent light, reduces the inflammatory response or organ dysfunction in patients undergoing 1) medical treatment for pneumonia, 2) a 2-stage arthroplasty for surgical management of a septic joint, 3) surgery for a necrotizing soft tissue infection (NSTI), and 4) surgery for an intraabdominal infection (e.g., diverticulitis).\n\nWe will expose participants to one of two (2) lighting conditions: 1) high illuminance (\\~1700 lux,), blue (442nm) spectrum enriched light and 2) ambient white fluorescent light that provides the standard environmental lighting (\\~300-400 lux, no predominant spectrum) of the hospital.\n\nBoth cohorts will be exposed to a 12 hours:12 hours light:dark cycle photoperiod. Those subjects assigned to blue light will be asked to shine this small portable blue enriched light on themselves from 0800 to 2000 for 3 days. At the transition from light to dark, the blue-enriched light is turned off, and additional blue wavelength light removed with an amber filter. Thus, the total period of intervention is 72 hours.\n\nThe outcome of interest is change in the inflammatory response after surgery for appendicitis or diverticulitis as measured by the following parameters: white blood cell count, heart rate, the development of abdominal abscess, serum cytokine concentrations.\n\nThe outcome of interest is change in the inflammatory response during pneumonia as measured by the following parameters: white blood cell count, heart rate, and serum cytokine concentrations.",[121,27,122,123],"Pneumonia","Intraabdominal Infections","Infection Joint",[125,126,127,128,129,130],"pneumonia","soft tissue infection","intraabdominal infections","circadian rhythms","blue light","sepsis","2026-02-08",{"date":133,"type":39},"2026-02-11",{"date":135,"type":39},"2024-10-29",{"date":67,"type":21},{"name":138,"class":46},"Washington University School of Medicine",{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":146,"targetDuration":4,"studyType":81,"phases":4,"briefSummary":147,"conditions":148,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":47},"100516291","shorter-versus-extended-course-of-antibiotic-therapy-for-necrotizing-soft-tissue-infections-100516291","NCT06002607","Shorter Versus Extended Course of Antibiotic Therapy for Necrotizing Soft Tissue Infections","Pilot Randomized Controlled Trial of Shorter Versus Extended Course of Antibiotic Therapy for Necrotizing Soft Tissue Infections","Inclusion Criteria:\n\n* Adult patients 18 years of age or older with all following criteria:\n* Presenting to the Emergency Department with history, exam and\u002For imaging concerning NSTI, AND\n* Patients who undergo consultation by the Emergency General Surgery service, AND\n* Patients included must have skin or soft tissue findings consistent with NSTI (erythema, crepitus, or pain out of proportion to exam), AND\n* Systemic signs of infection including fever (temperature \\>38.0°C) or leukocytosis (≥11,000 peripheral white cells per cubic millimeter), AND\n* Patients who undergo excisional debridement and\u002For amputation to achieve source control.\n\nExclusion Criteria:\n\n* Pregnant patients\n* Prisoners\n* Patients with bacteremia upon admission\n* Patients unable to provide consent (including no legally authorized representative)",{"count":55,"type":21},"Necrotizing soft tissue infection (NSTI) is a devastating disease that results in a high rate of in-hospital complications and despite advances in critical care, wound care, and early intervention, NSTI continues to be associated with a mortality rate of nearly 30%. The antibiotics used in this treatment are Clindamycin, Vancomycin, Piperacillin Tazobactam; these antibiotics may be administered combined or individually, based on individualized patient treatment. Although one of the tenets of management for NSTI is early broad-spectrum intravenous antibiotics (listed above), the duration of antibiotics needed is not well defined. Currently, there exists wide variation in the duration of antibiotics for NSTI ranging between 2-16 days. The objective of this study is to evaluate the safety of a shorter course of antibiotics hypothesizing that a short duration of antibiotics for 48-hours after source-control is achieved will have similar risk of morbidity and mortality compared to a 7-day course of antibiotics post source control. A second aim of this study will be to identify if serum procalcitonin levels\u002Fratio correspond to resolution of systemic infection in patients with NSTI.",[27],"2026-02-05",{"date":151,"type":39},"2026-02-10",{"date":153,"type":39},"2023-12-28",{"date":155,"type":21},"2026-12-01",{"name":157,"class":46},"University of California, Irvine"]