[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100452308":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":49,"centralContacts":54,"locations":64,"responsibleParty":84,"collaborators":36,"id":87,"slug":36,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":88,"sex":94,"minAge":95,"maxAge":36,"enrollmentInfo":96,"targetDuration":36,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":106,"overallStatus":67,"whyStopped":36,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"University of California, Irvine","OTHER",[8,14,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Acute Wounds - Control","PLACEBO_COMPARATOR","This arm will include patients with acute wounds and will receive standard of care: irrigation with normal saline.",[13],"Other: 0.9% Normal Saline - Irrigation",{"label":15,"type":16,"description":17,"interventionNames":18},"Acute Wounds - Experimental","EXPERIMENTAL","This arm will include patients with acute wounds and will receive experimental treatment: irrigation with micro\u002Fnanobubbles (MNB's) in normal saline.",[19],"Drug: Micro\u002Fnanobubble (MNB) - Irrigation",{"label":21,"type":10,"description":22,"interventionNames":23},"Chronic Wounds - Control","This arm will include patients with chronic wounds and will receive standard of care: negative pressure wound therapy with instillation (NPWTi) using normal saline.",[24],"Other: 0.9% Normal Saline - Negative Pressure Wound Therapy with Instillation (NPWTi)",{"label":26,"type":16,"description":27,"interventionNames":28},"Chronic Wounds - Experimental","This arm will include patients with chronic wounds and will receive experimental treatment: negative pressure wound therapy with instillation (NPWTi) using micro\u002Fnanobubbles (MNB's) in normal saline.",[29],"Drug: Micro\u002Fnanobubble (MNB) - Negative Pressure Wound Therapy with Instillation (NPWTi)",[31,37,41,45],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DRUG","Micro\u002Fnanobubble (MNB) - Irrigation","An MNB solution will be used as an irrigation solution to improve wound oxygenation in ischemic tissue (e.g. ischemic surgical tissue, traumatic wounds, and failing replants). The MNB solution will be used in wet-to-dry wound care dressings with daily scheduled dressing changes.",[15],null,{"type":6,"name":38,"description":39,"armGroupLabels":40,"otherNames":36},"0.9% Normal Saline - Irrigation","A normal saline solution will be used as an irrigation solution to improve wound oxygenation in ischemic tissue (e.g. ischemic surgical tissue, traumatic wounds, and failing replants). The normal saline solution will be used in wet-to-dry wound care dressings with daily scheduled dressing changes.",[9],{"type":32,"name":42,"description":43,"armGroupLabels":44,"otherNames":36},"Micro\u002Fnanobubble (MNB) - Negative Pressure Wound Therapy with Instillation (NPWTi)","NPWTi with MNB will be applied to the wound with 20-minute instillation periods every 3 hours (standard instillation settings) with dressing changes every 3-5 days.",[26],{"type":6,"name":46,"description":47,"armGroupLabels":48,"otherNames":36},"0.9% Normal Saline - Negative Pressure Wound Therapy with Instillation (NPWTi)","NPWTi with normal saline will be applied to the wound with 20-minute instillation periods every 3 hours (standard instillation settings) with dressing changes every 3-5 days.",[21],[50],{"name":51,"affiliation":52,"role":53},"Raj Vyas, MD","University of California, Irvine, Dept. of Plastic Surgery; Vice-Chairman","PRINCIPAL_INVESTIGATOR",[55,60],{"name":56,"role":57,"phone":58,"phoneExt":36,"email":59},"Leonardo Alaniz, BBA","CONTACT","602-318-7118","alanizl1@hs.uci.edu",{"name":61,"role":57,"phone":62,"phoneExt":36,"email":63},"Lohrasb R Sayadi, MD","949-209-7267","rsayadi@uci.edu",[65],{"facility":66,"status":67,"city":68,"state":69,"zip":70,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":79},"UCI Medical Center","RECRUITING","Orange","California","92868","United States","US",{"type":74,"coordinates":75},"Point",[76,77],-117.85311,33.78779,{"lat":77,"lon":76},[80,82],{"name":81,"role":57,"phone":58,"phoneExt":36,"email":59},"Leonardo Alaniz, MD",{"name":61,"role":57,"phone":83,"phoneExt":36,"email":63},"(949) 209-7267",{"type":53,"investigatorFullName":85,"investigatorTitle":86,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"Raj Vyas","Lead Investigator","100452308",false,"NCT05169814","Micro\u002FNanobubbles (MNBs) for Treatment of Acute and Chronic Wounds","Micro\u002FNanobubbles (MNBs) and Wound Therapy: A Pilot Study Involving a Novel Oxygen Delivery System for Treatment of Acute and Chronic Wounds","MNB","Inclusion Criteria:\n\n* are above the age of 18.\n* have traumatic, surgical, or chronic wounds.\n* have radiotherapy related tissue injury.\n* have thermal, chemical, and\u002For electrical burn injuries.\n* have pressure ulcers, diabetic foot ulcers, venous ulcers, arterial ulcers, and\u002For neuropathic skin ulcers.\n* have acute ischemic wounds\n\nExclusion Criteria:\n\n* have infected wounds.\n* have wounds with exposed vital structures such as nerves, arteries, and\u002For veins.\n* have wounds associated with malignancy.","ALL","18 Years",{"count":97,"type":98},40,"ESTIMATED","INTERVENTIONAL",[101],"EARLY_PHASE1","The purpose of this study is to assess the safety and efficacy of Micro\u002Fnanobubbles (MNB's) for the healing of acute and chronic wounds.",[104,105],"Open Wound","Wound Heal",[107,108,109,92,110,111,112],"acute wounds","chronic wounds","MNB solution","Micro\u002Fnanobubbles","Micronanobubbles","negative pressure wound therapy with instillation","2025-09-26",{"date":115,"type":116},"2025-10-02","ACTUAL",{"date":118,"type":116},"2021-10-09",{"date":120,"type":98},"2027-06-01",{"name":5,"class":6},1]