[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604168":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":33,"locations":24,"responsibleParty":40,"collaborators":24,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":24,"eligibilityCriteria":48,"healthyVolunteers":45,"sex":49,"minAge":50,"maxAge":24,"enrollmentInfo":51,"targetDuration":24,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":65,"whyStopped":24,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":24},{"fullName":5,"class":6},"Advanced Reconstructive Surgery Alliance","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard of care","ACTIVE_COMPARATOR","Patients receiving standard medical therapies for PMPS prevention (e.g., pharmacologic pain management, physical therapy).",[13],"Other: Standard of Care (Investigator Choice)",{"label":15,"type":16,"description":17,"interventionNames":18},"Nerve Surgery","EXPERIMENTAL","Patients undergoing prophylactic nerve surgery (RPNI) during second-stage implant exchange after tissue expander based breast reconstruction.",[19],"Procedure: Nerve Surgery",[21,25],{"type":22,"name":15,"description":17,"armGroupLabels":23,"otherNames":24},"PROCEDURE",[15],null,{"type":26,"name":27,"description":11,"armGroupLabels":28,"otherNames":24},"OTHER","Standard of Care (Investigator Choice)",[9],[30],{"name":31,"affiliation":5,"role":32},"Kari Colen, MD","PRINCIPAL_INVESTIGATOR",[34],{"name":35,"role":36,"phone":37,"phoneExt":38,"email":39},"Grace Wells, BS","CONTACT","732-741-0970","1889","gwells@sycamoremm.com",{"type":32,"investigatorFullName":41,"investigatorTitle":42,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Kari Colen","Medical Doctor","100604168","targeted-nerve-surgery-for-the-prevention-of-post-mastectomy-pain-syndrome-a-randomized-trial-100604168",false,"NCT07146009","Targeted Nerve Surgery for the Prevention of Post-Mastectomy Pain Syndrome: A Randomized Trial","Inclusion Criteria:\n\n* Adult patients (≥18 years old) undergoing second-stage implant exchange as part of tissue expander based breast reconstruction.\n* Patients with no prior diagnosis of PMPS.\n\nExclusion Criteria:\n\n* Prior nerve surgery in the chest region or chronic pain conditions unrelated to mastectomy.\n* Recent chest radiation (\\\u003C6 months), severe scarring, or active infection.\n* Uncontrolled diabetes, high-dose corticosteroids, or immunosuppressive therapy.\n* Psychiatric or cognitive impairments.\n* Pregnancy, or active lactation.\n* Autologous tissue based breast reconstruction.\n* Participation in another study within 6 months or inability to comply with follow-up.","ALL","18 Years",{"count":52,"type":53},60,"ESTIMATED","INTERVENTIONAL",[56],"NA","Post-Mastectomy Pain Syndrome (PMPS) is a chronic pain condition often caused by neuroma formation and nerve injury following breast cancer surgery. Standard breast reconstruction protocols typically do not address damaged intercostal nerves, leaving patients at risk for persistent nerve-related pain.\n\nProphylactic nerve surgery techniques, such as Targeted Muscle Reinnervation (TMR) and Regenerative Peripheral Nerve Interfaces (RPNI), offer innovative approaches to prevent neuroma formation by managing damaged nerves during surgery. This study will evaluate whether incorporating prophylactic nerve surgery during second-stage implant exchange after tissue expander based breast reconstruction can reduce the incidence of PMPS compared to standard medical therapies.",[59],"Breast Cancer",[61,62,63,64],"Post-mastectomy pain syndrome (PMPS)","Breast reconstruction","Regenerative Peripheral Nerve Interfaces","Targeted Muscle Reinnervation","NOT_YET_RECRUITING","2025-08-21",{"date":68,"type":69},"2025-08-28","ACTUAL",{"date":71,"type":53},"2025-10",{"date":73,"type":53},"2028-02-25",{"name":5,"class":6}]