[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100484259":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":44,"centralContacts":48,"locations":54,"responsibleParty":72,"collaborators":27,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":27,"eligibilityCriteria":81,"healthyVolunteers":77,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":27,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":56,"whyStopped":27,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"University of Alabama at Birmingham","OTHER",[8,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Pulsed Lavage Washout","EXPERIMENTAL","This cohort will undergo standard of care bilateral or unilateral mastectomies as determined by breast surgical oncologists and immediate standard of care breast reconstruction with tissue expander placement and pulsed lavage washout.",[13,14,15,16,17],"Other: Pulsed Lavage Washout","Procedure: Implant-based breast reconstruction","Procedure: Bilateral or unilateral mastectomy","Device: Tissue expander","Other: Acellular dermal matrix",{"label":19,"type":20,"description":21,"interventionNames":22},"No Pulsed Lavage","ACTIVE_COMPARATOR","This cohort will undergo standard of care bilateral or unilateral mastectomies as determined by breast surgical oncologists and immediate standard of care breast reconstruction with tissue expander placement.",[14,15,16,17],[24,28,33,37,41],{"type":6,"name":9,"description":25,"armGroupLabels":26,"otherNames":27},"Use of pressurized, pulsed triple antibiotic solution to irrigate mastectomy pocket",[9],null,{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":27},"PROCEDURE","Implant-based breast reconstruction","Standard of care; use of triple antibiotic solution delivered via bulb syringes to irrigate mastectomy pocket",[19,9],{"type":29,"name":34,"description":35,"armGroupLabels":36,"otherNames":27},"Bilateral or unilateral mastectomy","Standard of care",[19,9],{"type":38,"name":39,"description":35,"armGroupLabels":40,"otherNames":27},"DEVICE","Tissue expander",[19,9],{"type":6,"name":42,"description":35,"armGroupLabels":43,"otherNames":27},"Acellular dermal matrix",[19,9],[45],{"name":46,"affiliation":5,"role":47},"Richard J Fix, MD","PRINCIPAL_INVESTIGATOR",[49],{"name":50,"role":51,"phone":52,"phoneExt":27,"email":53},"Ann C Braswell, BS","CONTACT","256-595-3846","acb98@uab.edu",[55],{"facility":5,"status":56,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"RECRUITING","Birmingham","Alabama","35294","United States","US",{"type":63,"coordinates":64},"Point",[65,66],-86.80249,33.52066,{"lat":66,"lon":65},[69,71],{"name":50,"role":51,"phone":70,"phoneExt":27,"email":53},"2565953846",{"name":46,"role":47,"phone":27,"phoneExt":27,"email":27},{"type":47,"investigatorFullName":73,"investigatorTitle":74,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"Richard Jobe Fix","Professor in the Department of Plastic Surgery","100484259","pulsed-lavage-in-implant-based-breast-reconstruction-100484259",false,"NCT05585710","Pulsed Lavage in Implant-Based Breast Reconstruction","Pulsed Lavage in Implant-Based Breast Reconstruction: A Randomized Control Trial","Inclusion Criteria:\n\n* Female\n* Between 18 and 75 years of age, inclusive\n* Undergoing implant-based breast reconstruction (unilateral or bilateral) with immediate expander at mastectomy\n* Able to understand and willing to sign an Institutional Review Board (IRB) approved written informed consent document\n\nExclusion Criteria:\n\n* Male\n* \\\u003C 18 years of age or \\> 75 years of age\n* Undergoing implant-based breast reconstruction (unilateral or bilateral) with delayed expander at mastectomy","FEMALE","18 Years","75 Years",{"count":86,"type":87},62,"ESTIMATED","INTERVENTIONAL",[90],"NA","To determine if there is any benefit to using pulsed lavage to wash out the mastectomy pocket during breast reconstruction. Primary outcomes will include post-op complications including surgical site infection (SSI), hematoma, seroma, and implant failure.",[93],"Breast Reconstruction",[95,96,97],"breast reconstruction","implant-based breast reconstruction","pulsed lavage","2026-05-14",{"date":100,"type":101},"2026-05-18","ACTUAL",{"date":103,"type":101},"2024-03-01",{"date":105,"type":87},"2027-08",{"name":5,"class":6},1]