[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100566031":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":33,"locations":42,"responsibleParty":66,"collaborators":11,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":11,"eligibilityCriteria":74,"healthyVolunteers":75,"sex":76,"minAge":77,"maxAge":11,"enrollmentInfo":78,"targetDuration":11,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":11,"overallStatus":45,"whyStopped":11,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"University of North Carolina, Chapel Hill","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Xperience™ Advanced Surgical Irrigation","EXPERIMENTAL",null,[13],"Device: Xperience™ Advanced Surgical Irrigation",{"label":15,"type":16,"description":11,"interventionNames":17},"Dilute Povidone-Iodine","ACTIVE_COMPARATOR",[18],"Device: Dilute Povidone-Iodine",[20,24],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":11},"DEVICE","Xperience™ solution will be applied twice during reconstruction procedures: first after achieving hemostasis and second just before implant introduction. The solution will be warmed to body temperature before use. Both tissue expanders\u002Fimplants and mastectomy pockets will be soaked with Xperience™, using sterile syringes. A 1-minute dwell time with a total volume of 500 mL per mastectomy pocket will be employed, twice. Additionally, 500 mL of Xperience™ will be applied to implants before insertion, with a 5-minute dwell time. Excess solution will be suctioned throughout, and no rinsing will occur post-irrigation. Surgical site closure will follow standard procedures.",[9],{"type":21,"name":15,"description":25,"armGroupLabels":26,"otherNames":27},"5% dilute povidone-iodine solution will be prepared by mixing povidone-iodine solution and normal saline at the appropriate ratio. Both tissue expanders\u002Fimplants and mastectomy pockets will be soaked with dilute povidone-iodine, using sterile syringes. A 1-minute dwell time with a total volume of 500 mL per mastectomy pocket will be employed, twice. Additionally, 500 mL of dilute povidone-iodine will be applied to implants before insertion, with a 5-minute dwell time. Excess solution will be suctioned throughout. Surgeon discretion will determine rinsing after irrigation. Surgical site closure will follow standard procedures.",[15],[28],"Dilute Betadine",[30],{"name":31,"affiliation":5,"role":32},"Adeyemi Ogunleye, MD","PRINCIPAL_INVESTIGATOR",[34,38],{"name":31,"role":35,"phone":36,"phoneExt":11,"email":37},"CONTACT","(919) 966-4446","yemi@med.unc.edu",{"name":39,"role":35,"phone":40,"phoneExt":11,"email":41},"Alethia Burton","9198435547","alethia_burton@med.unc.edu",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"University of North Carolina at Chapel Hill Hospital","RECRUITING","Chapel Hill","North Carolina","27514","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-79.05584,35.9132,{"lat":55,"lon":54},[58,60,61,64],{"name":31,"role":35,"phone":59,"phoneExt":11,"email":37},"919-966-4446",{"name":39,"role":35,"phone":40,"phoneExt":11,"email":41},{"name":62,"role":63,"phone":11,"phoneExt":11,"email":11},"Grace A Longfellow, BS","SUB_INVESTIGATOR",{"name":65,"role":63,"phone":11,"phoneExt":11,"email":11},"Christina Kapsalis, MD",{"type":67,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100566031","a-novel-surgical-irrigation-solution-in-post-mastectomy-reconstruction-evaluating-xperience-100566031",false,"NCT06649890","A Novel Surgical Irrigation Solution in Post-Mastectomy Reconstruction: Evaluating Xperience™","A Randomized Control Trial Evaluating the Efficacy of Xperience™ Surgical Irrigation Solution Versus Dilute Povidone-Iodine in Preventing Surgical Site Infections and Improving Postoperative Outcomes in Implant-Based Breast Reconstruction","Inclusion Criteria:\n\n* Older than 18 years old\n* Willing to comply with all study-related procedures\n* Available for the duration of the study\n* Participants undergoing double mastectomy surgery followed by one of the following: (1) Immediate reconstruction with tissue expander placement, (2) Delayed reconstruction with tissue expander or implant placement, (3) Immediate reconstruction with implant placement, (4) Second-stage reconstruction with tissue expander to implant exchange\n\nExclusion Criteria:\n\n* Participants unable to participate in follow-up visits\n* Participants undergoing unilateral mastectomy\n* Tissue expanders placed by a surgeon outside of the UNC Chapel Hill Hospital System\n* Undergoing autologous reconstruction\n* Participant is unable to provide signed and dated informed consent\n* Unwilling or unable to comply with all study-related procedures.\n* Known history of sensitivity or allergic reaction to any of the components of the Xperience™ irrigation solution or dilute povidone-iodine irrigation\n* Participant with any conditions that would be a contraindication to receiving surgery such as contraindications to general anesthesia\n* Pregnant, planning to become pregnant or breast feeding participants\n* Individuals providing informed consent with any mental impairment or condition that would make them unable to properly consent without use of legally authorized representative (LAR) or additional participant protections.\n* Incarcerated participants",true,"FEMALE","18 Years",{"count":79,"type":80},224,"ESTIMATED","INTERVENTIONAL",[83],"NA","Goal of the Clinical Trial:\n\nThe purpose of this clinical trial is to learn whether Xperience™ surgical irrigation solution is more effective than a standard dilute povidone-iodine solution in reducing surgical site infections (SSIs) following implant-based breast reconstruction in female patients, aged 18 and older. It will also assess the safety and overall surgical outcomes when using Xperience™ compared to povidone-iodine.\n\nMain Questions the Study Aims to Answer:\n\n* Does the use of Xperience™ decrease the incidence of surgical site infections compared to povidone-iodine?\n* What are the differences in the rates of premature implant removal due to infection between patients treated with Xperience™ and those treated with povidone-iodine?\n* Are there fewer post-surgical complications with Xperience™ compared to povidone-iodine?\n\nStudy Design:\n\nParticipants in this study will be randomly assigned to receive either Xperience™ or a dilute povidone-iodine solution during their bilateral implant-based breast reconstruction. Only the research team will know which irrgiation is given- the participant will not know.\n\nParticipant Will:\n\n* Undergo the surgical procedure using one of the two irrigation solutions.\n* Receive regular post-operative check-ups to monitor for signs of infection and other complications.\n* Have data collected on any post-surgical complications, the necessity for early implant removal, and overall surgical outcomes.",[86,87,88,89],"Surgical Site Infection","Surgical Complication","Implant Infection","Implant Complication","2025-08-06",{"date":92,"type":93},"2025-08-07","ACTUAL",{"date":95,"type":93},"2025-06-30",{"date":97,"type":80},"2028-06-30",{"name":5,"class":6},1]