[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100455945":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":57,"collaborators":26,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":63,"acronym":26,"eligibilityCriteria":64,"healthyVolunteers":61,"sex":65,"minAge":66,"maxAge":26,"enrollmentInfo":67,"targetDuration":26,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":26,"overallStatus":40,"whyStopped":26,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"The Metis Foundation","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"KeraStat® Gel with Morphine","EXPERIMENTAL","Administration and application of KeraStat® Gel with Morphine (Bi-Weekly):\n\nKeraStat® Gel with Morphine will be formulated by mixing liquid Morphine 25mg\u002FmL into 5mg of KeraStat, this will be individually packaged in 5mL tubes at a concentration of 5mg\u002FmL. Each 5mL tube will cover and area of 300cm2 which is approximately 1.5% TBSA of an average, 60kg subject.\n\nHome Administration and application of KeraStat® Gel with Morphine (Every 1-3days):\n\nDressing is to be changed every 1-3 days, no more than once a day. Subjects will be provided the appropriate amount of pre-compounded KeraStat® Gel with Morphine in 5mL tubes.\n\nInstructions for application as above will be taught to subjects and instructions will be provided as subjects themselves or designated caretakers or home-care personnel will change their dressings as instructed by their physician with the addition of KeraStat® Gel administration as outlined above.",[13],"Drug: KeraStat® Gel with Morphine application",{"label":15,"type":16,"description":17,"interventionNames":18},"KeraStat® Gel","ACTIVE_COMPARATOR","Administration and application of KeraStat® Gel (Bi-Weekly):\n\nEach 5mL tube will cover and area of 300cm2 which is approximately 1.5% TBSA of an average, 60kg subject.\n\nHome Administration and application of KeraStat® Gel (Every 1-3days):\n\nDressing is to be changed every 1-3 days, no more than once a day. Subjects will be provided the appropriate amount of pre-compounded KeraStat® Gel 5mL tubes.\n\nInstructions for application as above will be taught to subjects and instructions will be provided as subjects themselves or designated caretakers or home-care personnel will change their dressings as instructed by their physician with the addition of KeraStat® Gel administration as outlined above.",[19],"Drug: KeraStat® Gel application",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","KeraStat® Gel with Morphine application","Administration and application of KeraStat® Gel with Morphine (Bi-Weekly):\n\nKeraStat® Gel with Morphine will be formulated by mixing liquid Morphine 25mg\u002FmL into 5mg of KeraStat, this will be individually packaged in 5mL tubes at a concentration of 5mg\u002FmL. Each 5mL tube will cover and area of 300cm2 which is approximately 1.5% TBSA of an average, 60kg subject.\n\nHome Administration and application of KeraStat® Gel with Morphine (Every 1-3days):\n\nDressing is to be changed every 1-3 days, no more than once a day. Subjects will be provided the appropriate amount of pre-compounded KeraStat® Gel with Morphine in 5mL tubes.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"KeraStat® Gel application","Administration and application of KeraStat® Gel (Bi-Weekly):\n\nEach 5mL tube will cover and area of 300cm2 which is approximately 1.5% TBSA of an average, 60kg subject.\n\nHome Administration and application of KeraStat® Gel (Every 1-3days):\n\nDressing is to be changed every 1-3 days, no more than once a day. Subjects will be provided the appropriate amount of pre-compounded KeraStat® Gel in 5mL tubes.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Victoria Diaz, RN","CONTACT","210-916-5760","Diaz@metisfoundationusa.org",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"South Texas Aesthetic and Reconstructive Surgery","RECRUITING","San Antonio","Texas","78229","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-98.49363,29.42412,{"lat":50,"lon":49},[53],{"name":54,"role":34,"phone":55,"phoneExt":26,"email":56},"Victoria Diaz","210-569-1140","diaz@metisfoundationusa.org",{"type":58,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100455945","phase-4-pilot-study-kerastat-gel-for-topical-delivery-of-morphine-for-management-of-non-healing-painful-open-wounds-and-ulcers-100455945",false,"NCT05217160","Pilot Study: KeraStat® Gel for Topical Delivery of Morphine for Management of Non-Healing, Painful Open Wounds and Ulcers","Inclusion Criteria:\n\n1. Subjects age 18 or older able to provide informed consent.\n2. Ulcer size 1-300 cm2\n\n4\\. Undermining\u002Ftunneling \\\u003C3 cm from wound margin 5. Grossly free of necrotic and\u002For infected tissue 6. Baseline minimum of 2 on VAS pain scale\n\nExclusion Criteria:\n\nSubjects who meet any of the following criteria will be excluded from the study:\n\n1. Known allergy to the standard of care or any of the ingredients in KeraStat® Gel or to morphine\n2. Wound has heavy or high-volume exudate or necrotic tissue\n3. Clinical signs of infection or contamination of the wound\n4. Subjects unable to complete the VAS pain score in pain journal\n5. Pregnant or nursing\n6. Prisoner\n7. Any condition the Investigator determines will compromise subject safety or prevent the subject from completing the study","ALL","18 Years",{"count":68,"type":69},24,"ESTIMATED","INTERVENTIONAL",[72],"PHASE4","This study is intended to provide information from subjects who currently have painful, chronically open wounds and assess the pain reduction capacity of KeraStat® Gel with Morphine. In gathering data from subjects who have baseline pain from their chronically open wounds, the investigators can then evaluate the capacity of KeraStat® Gel plus Morphine in reducing the subjects daily pain levels, pain associated with dressing changes, and pain medication consumption.",[75,76],"Wound of Skin","Burns","2022-01-19",{"date":79,"type":80},"2022-02-01","ACTUAL",{"date":82,"type":80},"2021-05-11",{"date":84,"type":69},"2022-05-31",{"name":5,"class":6},1]