[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602198":3},{"organization":4,"outcomesModule":7,"designInfo":52,"detailedDescription":17,"studyPopulation":17,"armGroups":58,"interventions":71,"overallOfficials":83,"centralContacts":88,"locations":94,"responsibleParty":111,"collaborators":113,"id":116,"slug":17,"hasResults":117,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":117,"sex":123,"minAge":124,"maxAge":17,"enrollmentInfo":125,"targetDuration":17,"studyType":128,"phases":129,"briefSummary":131,"conditions":132,"keywords":134,"overallStatus":96,"whyStopped":17,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},{"fullName":5,"class":6},"HealthPartners Institute","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":18},[9,13],{"measure":10,"description":11,"timeFrame":12},"Unplanned hospital readmission","Did the patient have an unplanned readmission to the hospital (Y\u002FN) within 30 days of discharge","Within 30 days of discharge",{"measure":14,"description":15,"timeFrame":16},"Rate of healing","Time from index debridement to final coverage in days","First operation and last operation",null,[19,23,26,29,32,35,39,42,45,49],{"measure":20,"description":21,"timeFrame":22},"Number of operative interventions","Number of times the patient required an operation related to their NSTI during their hospital stay","Through hospital discharge, median of 9 days",{"measure":24,"description":25,"timeFrame":22},"Unplanned vac change","Number of unplanned times the vacuum dressing had to be changed during their hospital stay",{"measure":27,"description":28,"timeFrame":22},"Total vac changes","Total number of times the vacuum dressing was changed (planned + unplanned) during their hospital stay",{"measure":30,"description":31,"timeFrame":22},"Bleeding","Bleeding at wound vac site (Y\u002FN). During hospital stay",{"measure":33,"description":34,"timeFrame":22},"Infection","New infection at wound vac site (Y\u002FN). During hospital stay",{"measure":36,"description":37,"timeFrame":38},"Hospital length of stay","Number of days spent in Hospital","At hospital discharge, median of 9 days",{"measure":40,"description":41,"timeFrame":38},"Intensive Care Unit length of stay","Number of days spent in the Intensive Care Unit",{"measure":43,"description":44,"timeFrame":38},"Floor length of stay","Number of days spent inpatient in the hospital",{"measure":46,"description":47,"timeFrame":48},"Skilled Nursing Facility days","Number of days spent in a skilled nursing facility","Up to 6 months after admission to skilled nursing facility",{"measure":50,"description":51,"timeFrame":38},"Discharge disposition","\"Where was the patient discharged: \"\"1=Discharged\u002FTransferred to a short-term general hospital for inpatient care 2=Discharged\u002FTransferred to an Intermediate Care Facility (ICF) 3=Discharged\u002FTransferred to home under care of organized home health service 4=Left against medical advice or discontinued care 5=Deceased\u002FExpired 6=Discharged to home or self-care (routine discharge) 7=Discharged\u002FTransferred to Skilled Nursing Facility (SNF) 8=Discharged\u002FTransferred to hospice care 9=Discharged\u002FTransferred to court\u002Flaw enforcement. 10=Discharged\u002FTransferred to inpatient rehab or designated unit 11=Discharged\u002FTransferred to Long Term Care Hospital (LTCH) 12=Discharged\u002FTransferred to a psychiatric hospital or psychiatric distinct part unit of a hospital 13=Discharged\u002FTransferred to another type of institution not defined elsewhere\"\"\"",{"allocation":53,"interventionModel":54,"interventionModelDescription":17,"primaryPurpose":55,"observationalModel":17,"timePerspective":17,"maskingInfo":56},"RANDOMIZED","PARALLEL","SUPPORTIVE_CARE",{"masking":57,"maskingDescription":17,"whoMasked":17},"NONE",[59,65],{"label":60,"type":61,"description":62,"interventionNames":63},"Negative Pressure Wound Therapy","ACTIVE_COMPARATOR","Patients in this arm will receive traditional Negative Pressure Wound Therapy (NPWT)",[64],"Device: Negative Pressure Wound Therapy",{"label":66,"type":67,"description":68,"interventionNames":69},"Negative Pressure Wound Therapy with Instillation","EXPERIMENTAL","Patients in this arm will receive Negative Pressure Wound Therapy with Instillation of a hypochlorous acid solution (NPWTi)",[70],"Device: Negative Pressure Wound Therapy with Instillation",[72,78],{"type":73,"name":60,"description":74,"armGroupLabels":75,"otherNames":76},"DEVICE","NPWT creates a vacuum seal over your wound to promote healing",[60],[77],"NPWT",{"type":73,"name":66,"description":79,"armGroupLabels":80,"otherNames":81},"NPWTi creates a vacuum seal over your wound and infuses the wound with hypochlorous acid (medical grade dilute bleach) to clean it.",[66],[82],"NPWTi",[84],{"name":85,"affiliation":86,"role":87},"Brian S Myer, MD","Regions Hospital","PRINCIPAL_INVESTIGATOR",[89],{"name":90,"role":91,"phone":92,"phoneExt":17,"email":93},"Nicholas J Larson","CONTACT","651-254-4846","RegionsSurgicalResearch@HealthPartners.com",[95],{"facility":86,"status":96,"city":97,"state":98,"zip":99,"country":100,"countryCode":101,"cosmosGeoPoint":102,"geoPoint":107,"contacts":108},"RECRUITING","Saint Paul","Minnesota","55101","United States","US",{"type":103,"coordinates":104},"Point",[105,106],-93.09327,44.94441,{"lat":106,"lon":105},[109,110],{"name":90,"role":91,"phone":92,"phoneExt":17,"email":93},{"name":85,"role":87,"phone":17,"phoneExt":17,"email":17},{"type":112,"investigatorFullName":17,"investigatorTitle":17,"investigatorAffiliation":17,"oldNameTitle":17,"oldOrganization":17},"SPONSOR",[114],{"name":115,"class":6},"University of Minnesota","100602198",false,"NCT07120386","Irrigating vs Traditional Negative Pressure Wound Therapy to Treat Necrotizing Soft Tissue Infections","Instillation vs Traditional Negative Pressure Wound Therapy: A Pilot Randomized Controlled Trial for Necrotizing Soft Tissue Infections (NPWTi-NSTI Trial)","NPWT-NSTI","Inclusion Criteria:\n\n* Clinical suspicion for Necrotizing Soft Tissue Infection (NSTI) necessitating emergent operative intervention\n* Age \\>\u002F=18 years old\n* Planned application of a negative pressure wound dressing\n\nExclusion Criteria:\n\n* Patients who have a wound that does not allow for a wound vac\n* Patients receiving acute treatment for a NSTI at another institution\n* Incarcerated patients\n* Patients who do not survive to wound closure\u002Fcoverage\n* Patients \\\u003C18 years old","ALL","18 Years",{"count":126,"type":127},30,"ESTIMATED","INTERVENTIONAL",[130],"NA","Necrotizing Soft Tissue Infections (NSTIs) are rapidly progressing infections that have a high morbidity and mortality, with the greatest morbidity related to managing the large wounds required to treat these patients. Initial treatment requires wide surgical removal of infected tissue and optimal management is essential to reducing morbidity in these patients. Negative pressure wound therapy (NPWT) is a widely used technology that has revolutionized wound management. NPWT is utilized across the spectrum of acute wounds, including routine postoperative incision management, traumatic wounds, and wounds related to surgical debridement of NSTIs which are frequently some of the most complicated of wounds encountered. Most NSTI cases at Regions Hospital currently utilize negative pressure wound therapy with instillation (NPWTi) where the wound is irrigated to clean out debris. Currently, there is a paucity of data comparing traditional NPWT and NPWTi and the choice of which device to use is left to surgeon discretion. This study is a first step at identifying the effects of NPWTi compared to NPWT alone on the care of NSTI patients. If the theoretical benefits of NPWTi over NPWT translate to practice, those treated with NPWTi would be expected to have a reduced rate of hospital readmission after their index hospitalization in addition to shorter time to definitive closure\u002Fcoverage. This is a pilot study to assess the feasibility of enrolling patients with NSTIs in a randomized controlled trial to assess outcomes between the two devices.",[133],"Necrotizing Soft Tissue Infections",[135,77,82],"Negative pressure wound therapy","2025-09-16",{"date":138,"type":139},"2025-09-17","ACTUAL",{"date":141,"type":139},"2025-08-01",{"date":143,"type":127},"2026-10",{"name":5,"class":6},1]