[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100597592":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":38,"studyPopulation":29,"armGroups":39,"interventions":50,"overallOfficials":58,"centralContacts":63,"locations":71,"responsibleParty":106,"collaborators":29,"id":109,"slug":29,"hasResults":110,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":29,"eligibilityCriteria":114,"healthyVolunteers":110,"sex":115,"minAge":116,"maxAge":29,"enrollmentInfo":117,"targetDuration":29,"studyType":120,"phases":121,"briefSummary":123,"conditions":124,"keywords":125,"overallStatus":74,"whyStopped":29,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},{"fullName":5,"class":6},"Rutgers, The State University of New Jersey","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":29},[9],{"measure":10,"description":11,"timeFrame":12},"Postoperative Pain","Pain assessed via the pain visual analog scale (VAS). The primary outcome measure will be assessed via online survey on post-operative day one then subsequently every other day until post-operative day fifteen.","From enrollment to post-operative day fifteen",[14,17,20,23,26],{"measure":15,"description":16,"timeFrame":12},"Number of Participants with post-tonsillectomy hemorrhage who receive topical agents","Number of Participants with post-tonsillectomy hemorrhage who receive topical agents for management of post tonsillectomy hemorrhage",{"measure":18,"description":19,"timeFrame":12},"Number of Participants with post-tonsillectomy hemorrhage who require a return to the operating room","Number of Participants with post-tonsillectomy hemorrhage who require a return to the operating room for management of post tonsillectomy hemorrhage",{"measure":21,"description":22,"timeFrame":12},"Number of participants who require hospital readmission for post tonsillectomy hemorrhage management","Number of participants who require readmission for management of post tonsillectomy hemorrhage",{"measure":24,"description":25,"timeFrame":12},"Number of participants who require a rescue analgesic for management following tonsillectomy procedure","Number of participants who use a rescue analgesic following their tonsillectomy procedure",{"measure":27,"description":28,"timeFrame":12},"Days participants take to resume their regular diet post operation","Recording how many days it takes for participants to return to their regular diet post operation",null,{"allocation":31,"interventionModel":32,"interventionModelDescription":29,"primaryPurpose":33,"observationalModel":29,"timePerspective":29,"maskingInfo":34},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":35,"maskingDescription":29,"whoMasked":36},"SINGLE",[37],"PARTICIPANT","This is a prospective study evaluating the impact of intraoperative RADA16 application on the postoperative course following tonsillectomy as it relates to pain, bleeding, readmission, and use of a rescue analgesic (ex., oxycodone). We propose a randomized controlled trial whereby patients undergoing tonsillectomy would either receive a standard analgesic regimen (postoperative acetaminophen and NSAIDs plus oxycodone as a supplemental analgesic) versus intraoperative RADA16 application plus a standard analgesic regimen.",[40,46],{"label":41,"type":42,"description":43,"interventionNames":44},"RADA16","ACTIVE_COMPARATOR","Patients randomized to the treatment arm will undergo application of 2.5% RADA16 hydrogel to the tonsillar fossae following tonsillectomy using a sterile syringe tip applicator. The gel will be spread into a thin layer within the tonsillar fossae. The gel will be left to sit for 60 seconds. A suction device will then be used to remove any excess RADA16 hydrogel, leaving a thin layer of RADA16 over the tonsillar fossae.",[45],"Device: RADA16 hydrogel",{"label":47,"type":48,"description":49,"interventionNames":29},"Control arm","NO_INTERVENTION","Patients randomized to the control arm will not undergo application of RADA16 hydrogel following hemostasis with suction monopolar electrocautery.",[51],{"type":52,"name":53,"description":54,"armGroupLabels":55,"otherNames":56},"DEVICE","RADA16 hydrogel","Application of 2.5% RADA16 hydrogel to the tonsillar fossae following tonsillectomy using a sterile syringe tip applicator. The gel will be spread into a thin layer within the tonsillar fossae. The gel will be left to sit for 60 seconds. A suction device will then be used to remove any excess RADA16 hydrogel, leaving a thin layer of RADA16 over the tonsillar fossae.",[41],[57],"puragel",[59],{"name":60,"affiliation":61,"role":62},"Wayne D Hsueh, MD","Rutgers University","PRINCIPAL_INVESTIGATOR",[64,68],{"name":60,"role":65,"phone":66,"phoneExt":29,"email":67},"CONTACT","973-972-4588","wayne.hsueh@rutgers.edu",{"name":69,"role":65,"phone":29,"phoneExt":29,"email":70},"Emily Kwon, BA","esk104@njms.rutgers.edu",[72,93],{"facility":73,"status":74,"city":75,"state":76,"zip":77,"country":78,"countryCode":79,"cosmosGeoPoint":80,"geoPoint":85,"contacts":86},"Cooperman Barnabas Medical Center","RECRUITING","Livingston","New Jersey","07039","United States","US",{"type":81,"coordinates":82},"Point",[83,84],-74.31487,40.79593,{"lat":84,"lon":83},[87,91],{"name":88,"role":65,"phone":89,"phoneExt":29,"email":90},"Gabriel Frimpong, MPH, PA","973-972-2309","gf345@njms.rutgers.edu",{"name":92,"role":62,"phone":29,"phoneExt":29,"email":29},"Wayne Hsueh, MD",{"facility":94,"status":95,"city":96,"state":76,"zip":97,"country":78,"countryCode":79,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"University Hospital","NOT_YET_RECRUITING","Newark","07103",{"type":81,"coordinates":99},[100,101],-74.17237,40.73566,{"lat":101,"lon":100},[104],{"name":88,"role":65,"phone":105,"phoneExt":29,"email":90},"9739722548",{"type":62,"investigatorFullName":107,"investigatorTitle":108,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"Wayne Daniel Hsueh, MD","ASSOC PROF-CLIN","100597592",false,"NCT07060495","RADA16 for Adult Tonsillectomy","Use of Novel Self-assembling RADA-16 Peptide Matrix to Decrease Postoperative Epistaxis for Tonsillectomy Surgeries","Inclusion criteria:\n\nAdults undergoing tonsillectomy (CPT codes)\n\nExclusion criteria:\n\nPatients undergoing adenoidectomy or uvulopalatopharyngoplasty in addition to tonsillectomy\n\nPatients who have had prior tonsillectomy or tonsillotomy\n\nPatient undergoing tonsillectomy with concern for malignancy\n\nPatients who are on opioids chronically prior to surgery\n\nPatients with an additional indication for pain management (i.e. unrelated to tonsillectomy)\n\nPatients who have been diagnosed with a bleeding disorder or hematologic malignancy\n\nPatients who are on anticoagulants\n\nThe following at-risk populations:\n\nAnyone under age 18\n\nPregnant women\n\nPrisoners\n\nAdults unable to consent (anyone lacking capacity)","ALL","18 Years",{"count":118,"type":119},134,"ESTIMATED","INTERVENTIONAL",[122],"PHASE3","The purpose of the research is to determine if RADA16 (also known as PuraStat®, PuraGel®, or PuraSinus®) improves patient outcomes following tonsillectomy procedures.\n\nResearchers will compare application of device RADA16 to application of no device to see if RADA16 works to treat post tonsillectomy hemorrhage.\n\nParticipants will:\n\n* Undergo tonsillectomy procedure.\n* Receive and fill out a survey sent via email every 2 days following their procedure for 15 days and track their symptoms.",[10],[126,127,128],"tonsillectomy","hemostasis","postop complications","2026-06-07",{"date":131,"type":132},"2026-06-10","ACTUAL",{"date":134,"type":132},"2025-09-12",{"date":136,"type":119},"2026-12-01",{"name":5,"class":6},2]