[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100530774":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":38,"centralContacts":43,"locations":49,"responsibleParty":88,"collaborators":31,"id":91,"slug":92,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":93,"sex":99,"minAge":31,"maxAge":31,"enrollmentInfo":100,"targetDuration":31,"studyType":103,"phases":104,"briefSummary":106,"conditions":107,"keywords":113,"overallStatus":52,"whyStopped":31,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"University of British Columbia","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard of Care","ACTIVE_COMPARATOR","The Standard of Care arm will consist of the scalpel for the initial skin incision and further randomization to have completion of the surgery with standard electrocautery or PEAK PlasmaBlade.",[13],"Device: Scalpel and standard electrocautery or PEAK PlasmaBlade",{"label":15,"type":16,"description":17,"interventionNames":18},"PEAK PlasmaBlade","EXPERIMENTAL","The PEAK PlasmaBlade will be used for the entirety of the surgery, including the initial skin incision.",[19],"Device: PEAK PlasmaBlade",{"label":21,"type":16,"description":22,"interventionNames":23},"Standard Electrocautery","Standard electrocautery will be used for the entirety of the surgery, including the initial skin incision.",[24],"Device: Standard Electrocautery",[26,32,35],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DEVICE","Scalpel and standard electrocautery or PEAK PlasmaBlade","Scalpel followed by completion of surgery with standard electrocautery or PEAK PlasmaBlade.",[9],null,{"type":27,"name":15,"description":33,"armGroupLabels":34,"otherNames":31},"PEAK PlasmaBlade for entire surgery.",[15],{"type":27,"name":21,"description":36,"armGroupLabels":37,"otherNames":31},"Standard Electrocautery for entire surgery.",[21],[39],{"name":40,"affiliation":41,"role":42},"Carol K Dingee, MD, FRCSC","Providence Health Care, University of British Columbia","PRINCIPAL_INVESTIGATOR",[44],{"name":40,"role":45,"phone":46,"phoneExt":47,"email":48},"CONTACT","6048741141","78609","cdingee2@providencehealth.bc.ca",[50],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Mount Saint Joseph Hospital","RECRUITING","Vancouver","British Columbia","V5T 3N4","Canada","CA",{"type":59,"coordinates":60},"Point",[61,62],-123.11934,49.24966,{"lat":62,"lon":61},[65,66,68,70,72,74,76,78,80,82,84,86],{"name":40,"role":45,"phone":46,"phoneExt":47,"email":48},{"name":67,"role":45,"phone":31,"phoneExt":31,"email":31},"Carol K Dingee, MC, FRCSC",{"name":69,"role":45,"phone":31,"phoneExt":31,"email":31},"Amy K Bazzarelli, MD, FRCSC",{"name":71,"role":45,"phone":31,"phoneExt":31,"email":31},"Melina Deban, MD, FRCSC",{"name":73,"role":45,"phone":31,"phoneExt":31,"email":31},"Elaine C McKevitt, MD, FRCSC",{"name":75,"role":45,"phone":31,"phoneExt":31,"email":31},"Jieun Newman-Bremang, MD, FRCSC",{"name":77,"role":45,"phone":31,"phoneExt":31,"email":31},"Jin-Si Pao, MD, FRCSC",{"name":79,"role":45,"phone":31,"phoneExt":31,"email":31},"Rebecca Warburton, MD, FRCSC",{"name":81,"role":45,"phone":31,"phoneExt":31,"email":31},"Kathryn Isaac, MD, FRCSC",{"name":83,"role":45,"phone":31,"phoneExt":31,"email":31},"Lisa Aird, MD, FRCSC",{"name":85,"role":45,"phone":31,"phoneExt":31,"email":31},"Yuwei Yang, MSc",{"name":87,"role":45,"phone":31,"phoneExt":31,"email":31},"Bennett B Westmore",{"type":42,"investigatorFullName":89,"investigatorTitle":90,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Carol Dingee","Breast Surgical Oncologist, Principal Investigator, Clinical Professor","100530774","cosmetic-outcome-of-electrocautery-scalpel-and-peak-plasmablade-for-surgical-breast-incisions-100530774",false,"NCT06191159","Cosmetic Outcome of Electrocautery, Scalpel and PEAK PlasmaBlade for Surgical Breast Incisions","A Randomized Controlled Trial Comparing the Cosmetic Outcome of Electrocautery, Scalpel and PEAK PlasmaBlade for Surgical Breast Incisions","SCPPB","Inclusion Criteria:\n\n* Patients having a total mastectomy with or without axilla surgical staging\n\nExclusion Criteria:\n\n* Patients having immediate breast reconstruction\n* Patients with a diagnosis of inflammatory breast cancer\n* History of keloid scar formation\n* History of connective tissue disorder (scleroderma or rheumatoid arthritis with skin involvement)\n* Patients with prior incision at the planned mastectomy site.\n* Patients with known suture hypersensitivity\n* Patients with evidence of current infection","ALL",{"count":101,"type":102},186,"ESTIMATED","INTERVENTIONAL",[105],"NA","This study will compare the cosmetic scar result from the use of scalpel, electrocautery, and pulsed electron avalanche knife (PEAK) PlasmaBlade (PPB) for the initial skin incision for total mastectomy procedures without immediate breast reconstruction.\n\nIt is hypothesized that there will be no significant difference in mastectomy scar cosmesis.\n\nThe purpose and objectives of this study are:\n\n1. To evaluate and compare the cosmetic scar result from the use of scalpel, standard electrocautery, or PEAK PlasmaBlade for initial incision for total mastectomy procedures without immediate breast reconstruction.\n2. To inform future equipment choices for breast surgery including potential elimination of scalpels and their attendant risks.",[108,109,110,111,112],"Wound Complication","Surgical Wound Infection","Post-operative Pain","Postoperative Complications","Scar",[114,15,115,116,117],"Electrocautery","Scalpel","Mastectomy","Incision","2024-12-10",{"date":120,"type":121},"2024-12-16","ACTUAL",{"date":123,"type":121},"2024-12-09",{"date":125,"type":102},"2025-12",{"name":5,"class":6},1]