[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100418616":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":39,"locations":49,"responsibleParty":164,"collaborators":168,"id":179,"slug":43,"hasResults":180,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":184,"eligibilityCriteria":185,"healthyVolunteers":186,"sex":187,"minAge":188,"maxAge":43,"enrollmentInfo":189,"targetDuration":43,"studyType":192,"phases":193,"briefSummary":195,"conditions":196,"keywords":43,"overallStatus":52,"whyStopped":43,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":213},{"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",[50,67,81,95,110,124,138,151],{"facility":51,"status":52,"city":53,"state":43,"zip":54,"country":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Aalborg University Hospital","RECRUITING","Aalborg","9000","Denmark",{"type":57,"coordinates":58},"Point",[59,60],9.9187,57.048,{"lat":60,"lon":59},[63],{"name":64,"role":41,"phone":65,"phoneExt":43,"email":66},"Lene Birk-Sørensen, MD","+45 97660624","l.birksoerensen@rn.dk",{"facility":68,"status":52,"city":69,"state":43,"zip":70,"country":55,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"Aarhus University Hospital","Aarhus","8000",{"type":57,"coordinates":72},[73,74],10.21076,56.15674,{"lat":74,"lon":73},[77],{"name":78,"role":41,"phone":79,"phoneExt":43,"email":80},"Mikkel Rindom, MD","+45 24 60 93 21","MIKKOC@rm.dk",{"facility":82,"status":52,"city":83,"state":43,"zip":84,"country":55,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"Rigshospitalet","Copenhagen","2100",{"type":57,"coordinates":86},[87,88],12.56553,55.67594,{"lat":88,"lon":87},[91,93],{"name":92,"role":41,"phone":42,"phoneExt":43,"email":44},"Mikkel Herly, MD, Phd",{"name":94,"role":41,"phone":47,"phoneExt":43,"email":48},"Mathilde N Hemmingsen, MD",{"facility":96,"status":97,"city":98,"state":43,"zip":99,"country":55,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"South-West Jutland Hospital","NOT_YET_RECRUITING","Esbjerg","6700",{"type":57,"coordinates":101},[102,103],8.45187,55.47028,{"lat":103,"lon":102},[106],{"name":107,"role":41,"phone":108,"phoneExt":43,"email":109},"Lena F Carstensen, MD","+45 20 15 20 19","Lena.Felicia.Carstensen@rsyd.dk",{"facility":111,"status":52,"city":112,"state":43,"zip":113,"country":55,"cosmosGeoPoint":114,"geoPoint":118,"contacts":119},"Herlev and Gentofte Hospital","Herlev","2730",{"type":57,"coordinates":115},[116,117],12.43998,55.72366,{"lat":117,"lon":116},[120],{"name":121,"role":41,"phone":122,"phoneExt":43,"email":123},"Lisbet R Hölmich, MD, DMSc","+45 27 20 00 14","lisbet.rosenkrantz.hoelmich@regionh.dk",{"facility":125,"status":52,"city":126,"state":43,"zip":127,"country":55,"cosmosGeoPoint":128,"geoPoint":132,"contacts":133},"Odense University Hospital","Odense","5000",{"type":57,"coordinates":129},[130,131],10.38831,55.39594,{"lat":131,"lon":130},[134],{"name":135,"role":41,"phone":136,"phoneExt":43,"email":137},"Camilla Bille, Phd","+45 65 41 24 45","Camilla.Bille@rsyd.dk",{"facility":139,"status":52,"city":140,"state":43,"zip":141,"country":55,"cosmosGeoPoint":142,"geoPoint":146,"contacts":147},"Zealand University Hospital","Roskilde","4000",{"type":57,"coordinates":143},[144,145],12.08035,55.64152,{"lat":145,"lon":144},[148],{"name":149,"role":41,"phone":43,"phoneExt":43,"email":150},"Michael Rose, MD","mrose@regionsjaelland.dk",{"facility":152,"status":97,"city":153,"state":43,"zip":154,"country":55,"cosmosGeoPoint":155,"geoPoint":159,"contacts":160},"Vejle Hospital","Vejle","7100",{"type":57,"coordinates":156},[157,158],9.5357,55.70927,{"lat":158,"lon":157},[161],{"name":162,"role":41,"phone":43,"phoneExt":43,"email":163},"Bekka Christensen, MD","Bekka.Anina.Ozer.Christensen@rsyd.dk",{"type":165,"investigatorFullName":166,"investigatorTitle":167,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"SPONSOR_INVESTIGATOR","Mikkel Herly","MD, Ph.d.",[169,171,172,173,174,175,177,178],{"name":170,"class":6},"University of Copenhagen",{"name":111,"class":6},{"name":139,"class":6},{"name":125,"class":6},{"name":152,"class":6},{"name":176,"class":6},"Esbjerg Hospital - University Hospital of Southern Denmark",{"name":68,"class":6},{"name":51,"class":6},"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":190,"type":191},1003,"ESTIMATED","INTERVENTIONAL",[194],"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.",[197,198,199,200,201,202,203],"Implant Complication","Implant Infection","Implant Site Infection","Implant Capsular Contracture","Implant Site Pocket Infection","Implant Expulsion","Antibiotic Side Effect","2026-02-09",{"date":206,"type":207},"2026-02-12","ACTUAL",{"date":209,"type":207},"2021-01-27",{"date":211,"type":191},"2027-08",{"name":166,"class":6},8]