[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100418616":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":39,"locations":49,"responsibleParty":165,"collaborators":169,"id":180,"slug":181,"hasResults":182,"nctId":183,"briefTitle":184,"officialTitle":185,"acronym":186,"eligibilityCriteria":187,"healthyVolunteers":188,"sex":189,"minAge":190,"maxAge":43,"enrollmentInfo":191,"targetDuration":43,"studyType":194,"phases":195,"briefSummary":197,"conditions":198,"keywords":43,"overallStatus":52,"whyStopped":43,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":215},{"fullName":5,"class":6},"Rigshospitalet, Denmark","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Irrigation of implants with sterile isotonic saline","PLACEBO_COMPARATOR","The placebo solution will consist of 500 mL of sterile isotonic (9%) saline contained in a infusion bag.",[13],"Other: Placebo",{"label":15,"type":16,"description":17,"interventionNames":18},"Irrigation of implants with a triple antibiotic solution","EXPERIMENTAL","The antibiotic solution will contain 1000 mg vancomycin, 80 mg gentamicin and 1000 mg cefazolin in 500 mL sterile isotonic (9%) saline",[19],"Drug: Gentamicin, Cefazolin and Vancomycin",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Gentamicin, Cefazolin and Vancomycin","The antibiotic solution will contain 1000 mg vancomycin, 80 mg gentamicin and 1000 mg cefazolin in a 500 mL isotonic saline solution. The solution will be used to wash the dissected implant pocket and the implant prior to insertion in the implant pocket.",[15],[27],"Hexamycin, Cefazolin \"MIP\" and Bactocin",{"type":6,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Placebo","500 mL of sterile isotonic (9%) saline. The solution will be used to wash the dissected implant pocket and the implant prior to insertion in the implant pocket.",[9],[33],"Natriumklorid Fresenius Kabi 9 mg-ml",[35],{"name":36,"affiliation":37,"role":38},"Mikkel Herly, MD, Ph.D.","Department of Plastic Surgery and Burns Treatment","PRINCIPAL_INVESTIGATOR",[40,45],{"name":36,"role":41,"phone":42,"phoneExt":43,"email":44},"CONTACT","+45 27598919",null,"mikkel.herly@regionh.dk",{"name":46,"role":41,"phone":47,"phoneExt":43,"email":48},"Mathilde Hemmingsen, MD","+45 28568205","mathilde.nejrup.hemmingsen@regionh.dk",[50,68,82,96,111,125,139,152],{"facility":51,"status":52,"city":53,"state":43,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Aalborg University Hospital","RECRUITING","Aalborg","9000","Denmark","DK",{"type":58,"coordinates":59},"Point",[60,61],9.9187,57.048,{"lat":61,"lon":60},[64],{"name":65,"role":41,"phone":66,"phoneExt":43,"email":67},"Lene Birk-Sørensen, MD","+45 97660624","l.birksoerensen@rn.dk",{"facility":69,"status":52,"city":70,"state":43,"zip":71,"country":55,"countryCode":56,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"Aarhus University Hospital","Aarhus","8000",{"type":58,"coordinates":73},[74,75],10.21076,56.15674,{"lat":75,"lon":74},[78],{"name":79,"role":41,"phone":80,"phoneExt":43,"email":81},"Mikkel Rindom, MD","+45 24 60 93 21","MIKKOC@rm.dk",{"facility":83,"status":52,"city":84,"state":43,"zip":85,"country":55,"countryCode":56,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"Rigshospitalet","Copenhagen","2100",{"type":58,"coordinates":87},[88,89],12.56553,55.67594,{"lat":89,"lon":88},[92,94],{"name":93,"role":41,"phone":42,"phoneExt":43,"email":44},"Mikkel Herly, MD, Phd",{"name":95,"role":41,"phone":47,"phoneExt":43,"email":48},"Mathilde N Hemmingsen, MD",{"facility":97,"status":98,"city":99,"state":43,"zip":100,"country":55,"countryCode":56,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"South-West Jutland Hospital","NOT_YET_RECRUITING","Esbjerg","6700",{"type":58,"coordinates":102},[103,104],8.45187,55.47028,{"lat":104,"lon":103},[107],{"name":108,"role":41,"phone":109,"phoneExt":43,"email":110},"Lena F Carstensen, MD","+45 20 15 20 19","Lena.Felicia.Carstensen@rsyd.dk",{"facility":112,"status":52,"city":113,"state":43,"zip":114,"country":55,"countryCode":56,"cosmosGeoPoint":115,"geoPoint":119,"contacts":120},"Herlev and Gentofte Hospital","Herlev","2730",{"type":58,"coordinates":116},[117,118],12.43998,55.72366,{"lat":118,"lon":117},[121],{"name":122,"role":41,"phone":123,"phoneExt":43,"email":124},"Lisbet R Hölmich, MD, DMSc","+45 27 20 00 14","lisbet.rosenkrantz.hoelmich@regionh.dk",{"facility":126,"status":52,"city":127,"state":43,"zip":128,"country":55,"countryCode":56,"cosmosGeoPoint":129,"geoPoint":133,"contacts":134},"Odense University Hospital","Odense","5000",{"type":58,"coordinates":130},[131,132],10.38831,55.39594,{"lat":132,"lon":131},[135],{"name":136,"role":41,"phone":137,"phoneExt":43,"email":138},"Camilla Bille, Phd","+45 65 41 24 45","Camilla.Bille@rsyd.dk",{"facility":140,"status":52,"city":141,"state":43,"zip":142,"country":55,"countryCode":56,"cosmosGeoPoint":143,"geoPoint":147,"contacts":148},"Zealand University Hospital","Roskilde","4000",{"type":58,"coordinates":144},[145,146],12.08035,55.64152,{"lat":146,"lon":145},[149],{"name":150,"role":41,"phone":43,"phoneExt":43,"email":151},"Michael Rose, MD","mrose@regionsjaelland.dk",{"facility":153,"status":98,"city":154,"state":43,"zip":155,"country":55,"countryCode":56,"cosmosGeoPoint":156,"geoPoint":160,"contacts":161},"Vejle Hospital","Vejle","7100",{"type":58,"coordinates":157},[158,159],9.5357,55.70927,{"lat":159,"lon":158},[162],{"name":163,"role":41,"phone":43,"phoneExt":43,"email":164},"Bekka Christensen, MD","Bekka.Anina.Ozer.Christensen@rsyd.dk",{"type":166,"investigatorFullName":167,"investigatorTitle":168,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"SPONSOR_INVESTIGATOR","Mikkel Herly","MD, Ph.d.",[170,172,173,174,175,176,178,179],{"name":171,"class":6},"University of Copenhagen",{"name":112,"class":6},{"name":140,"class":6},{"name":126,"class":6},{"name":153,"class":6},{"name":177,"class":6},"Esbjerg Hospital - University Hospital of Southern Denmark",{"name":69,"class":6},{"name":51,"class":6},"100418616","phase-3-local-antibiotics-for-breast-implants-100418616",false,"NCT04731025","Local Antibiotics for Breast Implants","Prophylactic Treatment of Breast Implants With a Solution of Gentamicin, Vancomycin and Cefazolin Antibiotics for Women Undergoing Breast Reconstructive Surgery: a Randomized Controlled Trial (The BREAST-AB Trial)","BREAST-AB","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Biologically female\n* Signed informed consent\n* Scheduled for breast reconstruction with implants or expanders including:\n\n  1. Immediate or delayed reconstructions\n  2. Bilateral or unilateral reconstructions\n  3. With or without simultaneous flap reconstruction\n\nExclusion Criteria:\n\n* Pregnancy\n* Breast feeding\n* Known allergy towards Vancomycin, Gentamicin and Cefazolin\n* Known anaphylactic reaction towards other beta-lactam antibiotics or aminoglycosides\n* Known allergy towards neomycin\n* Known impaired renal function with GFR \\\u003C 60 mL\u002Fmin\n* Participation in investigational drug trials and projects concerning disinfecting agents in the breast implant cavity\n* Myasthenia Gravis",true,"FEMALE","18 Years",{"count":192,"type":193},1003,"ESTIMATED","INTERVENTIONAL",[196],"PHASE3","The BREAST-AB Trial is a multi-center, randomized, double blind, placebo-controlled trial investigating the efficacy of local application of gentamicin, vancomycin and cefazolin in decreasing all-cause implant explantation after breast reconstruction.",[199,200,201,202,203,204,205],"Implant Complication","Implant Infection","Implant Site Infection","Implant Capsular Contracture","Implant Site Pocket Infection","Implant Expulsion","Antibiotic Side Effect","2026-02-09",{"date":208,"type":209},"2026-02-12","ACTUAL",{"date":211,"type":209},"2021-01-27",{"date":213,"type":193},"2027-08",{"name":167,"class":6},8]