[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"skin-necrosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:skin-necrosis":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,47,77],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":4},"100619131","b4p-trial---bloom43-for-preconditioning-100619131",false,"NCT07340632","B4P Trial - BLOOM43 for Preconditioning","BLOOM43 for Preconditioning (B4P): A Pilot Study to Evaluate the Use of the Plexaa Preconditioning Device (BLOOM43) for Reconstructive Breast Surgery - A Prospective Cohort Multicentre Study","Inclusion Criteria:\n\n* All females over the age of 18 years (no maximum age limit)\n* Patients undergoing skin-sparing mastectomy or nipple-sparing mastectomy and immediate breast reconstruction (autologous and\u002For implant)\n\nExclusion Criteria:\n\n* Delayed (two-stage) breast reconstruction patients\n* Patients undergoing simple mastectomy or wide local excision of a breast tumour\n* Inflammatory breast cancer patients\n* Patients with ulcerated breast tumours\n* Patents with T4 breast cancer\n* Presence of open breast skin wounds, or infected or inflamed breast skin\n* Presence of a cardiac pacemaker, defibrillator or any other implantable electronic device","FEMALE","18 Years",{"count":19,"type":20},60,"ESTIMATED","INTERVENTIONAL",[23],"NA","The goal of this clinical trial is to evaluate the use of the Plexaa preconditioning device (BLOOM43) in patients undergoing reconstructive breast surgery for breast cancer. This study aims to understand a participant's experience of the device, including its usability and acceptability.\n\nParticipants will use the device to precondition their breast the evening before undergoing surgery (mastectomy with immediate autologous and\u002For implant-based reconstruction).",[26,27,28],"Skin Necrosis","Breast Reconstruction","Breast Surgery",[30,31,32,33,34],"Mastectomy skin flap necrosis","Breast reconstruction","Breast surgery","Preconditioning","Skin necrosis","NOT_YET_RECRUITING","2026-03-17",{"date":38,"type":39},"2026-03-19","ACTUAL",{"date":41,"type":20},"2026-04-16",{"date":43,"type":20},"2026-12-31",{"name":45,"class":46},"Plexaa Ltd","INDUSTRY",{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":57,"conditions":58,"keywords":61,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":4},"100589594","prediction-of-icg-for-skin-necrosis-in-mastectomy-with-immediate-reconstruction-100589594","NCT06956443","Prediction of ICG for Skin Necrosis in Mastectomy With Immediate Reconstruction","The Predictive Value of Quantified Indocyanine Green Fluorescent Angiography for Skin Necrosis in Mastectomy With Immediate Reconstruction","Inclusion Criteria:\n\n1. Age \\>18 years\n2. Patients undergoing mastectomy with immediate reconstruction using ICG-NIR\n3. Patients are mentally competent\n4. Written informed consent\n\nExclusion Criteria:\n\n1. Patients with known allergy to ICG or iodinated contrast media\n2. Pregnant or lactating women\n3. Patients with dialysis-dependent renal failure and renal transplantation",{"count":55,"type":20},50,"OBSERVATIONAL","Background Breast cancer represents 30 percent of newly diagnosed malignancies in female patients and is the leading cause of death in middle-aged women. Surgical treatment of breast cancer is performed with breast-conserving surgery or mastectomy. An increasing proportion of breast cancer patients undergo breast reconstruction after mastectomy. Reconstruction can be performed using various techniques that may involve the use of autologous tissues, implants, or a combination of both. However, mastectomy followed by immediate reconstruction can be associated with complications, including skin and fat necrosis, which occurs in 20% of cases.\n\nWhen assessing tissue perfusion during immediate reconstruction, the surgeon relies on subjective observations, including skin color, capillary refill, and the occurrence of bleeding. One possible technique to assist the surgeon in assessing tissue perfusion is near-infrared (NIR) fluorescence imaging with Indocyanine Green (ICG). ICG can visualize tissue perfusion, because once in the bloodstream it is completely and permanently fixed to plasma proteins and circulates only in the intravascular compartment. ICG was approved for clinical use of tissue perfusion as early as 1956, such as in intestinal anastomoses, for the perfusion of free flaps or parathyroid glands.\n\nICG can also help predict postoperative skin necrosis in breast reconstruction after mastectomy. In patients undergoing (reconstructive) breast surgery, the intraoperative use of ICG NIR fluorescence imaging has been shown to help surgeons assess skin viability, thereby reducing the occurrence of skin necrosis in several studies. This reduction in necrosis can be explained by the intraoperative removal of tissue with reduced fluorescence intensity, observed with ICG NIR fluorescence imaging. However, there is no consensus on which ICG-NIR perfusion parameter is most accurate for assessing tissue perfusion. Further research is needed to determine cut-off values for adequate tissue perfusion. This study focuses on quantifying perfusion parameters and determining the diagnostic accuracy of ICG-NIR in patients undergoing mastectomy with immediate reconstruction.\n\nWhat is the purpose of the study\u002Fresearch question? The purpose of this study is to determine the predictive value of quantified ICG fluorescence angiography for the occurrence of skin necrosis in patients undergoing mastectomy with immediate reconstruction with associated cut-off values.\n\nStudy design\u002Fprocedure and intervention:\n\nThis will be a prospective cohort study of patients undergoing mastectomy with immediate reconstruction using ICG-NIR (the use of ICG during these operations is not an additional procedure).\n\nThis study will include patients who have undergone surgery with ICG (mastectomy with immediate reconstruction). We will use the videos of the ICG angiography for quantitative analysis of the data. This data will be correlated with the postoperative outcome (occurrence of skin\u002Ffat necrosis).\n\nAll patients will be asked in advance for permission to use their data. This will be processed pseudo-anonymously.",[59,60,26],"Breast Cancers","Mastectomy and Breast Reconstruction",[62,63,64,65,66],"ICG","mastectomy","breast cancer","breast reconstruction","skin necrosis","2025-04-25",{"date":69,"type":39},"2025-05-04",{"date":71,"type":20},"2025-06-01",{"date":73,"type":20},"2026-12-01",{"name":75,"class":76},"University Medical Center Groningen","OTHER",{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":84,"enrollmentInfo":85,"targetDuration":87,"studyType":56,"phases":4,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":106},"100509246","efficacy-of-angiography-with-indocyanine-green-in-the-identification-of-complications-after-breast-surgery-100509246","NCT05910931","Efficacy of Angiography With Indocyanine Green in the Identification of Complications After Breast Surgery","Prospective Study for the Evaluation of the Efficacy and Concordance of Angiography With Indocyanine Green in the Identification of Complications After Oncoplastic Surgery and Skin and Nipple-skin Sparing Mastectomy","Inclusion Criteria:\n\nThe study population includes two type of patients:\n\n* Women who underwent oncoplastic procedures for breast conservation. This group is made up of women with breast cancer in whom the Breast Unit tumor committee recommended a breast-conserving surgical procedure. The techniques included for this study are vertical mammoplasty, horizontal mammoplasty, and local flaps by displacement or rotation.\n* Women undergoing a skin or skin\u002Fnipple-sparing mastectomy with immediate breast reconstruction. This group is made up of patients with a diagnosis of breast carcinoma, who require a mastectomy as surgical treatment, as well as those high-risk women whose mastectomy is aimed at reducing the risk of breast cancer. The surgical techniques included in this group are Carlson type 1, 2, 3 and 4 skin-sparing mastectomies and nipple and skin-sparing mastectomies using inframammary and vertical approaches. In all patients, the type of breast reconstruction will be the placement of a definitive implant in the prepectoral position.\n\nExclusion Criteria:\n\n\\- Women with iodine allergy or thyroid disease are excluded from this study.","100 Years",{"count":86,"type":20},221,"3 Months","During the performance of oncoplastic surgery and skin-sparing or skin-nipple mastectomy there is a significant loss in the perfusion of the cutaneous envelope of the breast, which can produce areas of vascular suffering of the skin that sometimes cause necrosis of the same. Skin necrosis is the most important adverse event in oncoplastic and reconstructive surgery of the breast, since it causes delays in adjuvant treatments to surgery, worsening of the cosmetic result, and, on occasions, loss of the implant and reconstruction.\n\nIndocyanine color green (ICG) angiography has been proposed as a diagnostic alternative to determine the vascular perfusion of the skin envelope of the breast during surgery, which would allow the removal of tissue at risk of necrosis to avoid this complication during the postoperative period. However, the scientific literature does not currently allow an adequate assessment of this diagnostic procedure due to the absence of prospective studies that have evaluated its sensitivity, specificity, and predictive values.\n\nThe objective of this prospective study is to evaluate ICG angiography of skin flaps of the breast and the surgeon's decision in women with breast cancer or at high risk for breast cancer undergoing oncoplastic surgery or mastectomy with the help of skin or skin-nipple. Based on the results of this study, the sensitivity, specificity, and predictive values of this technique for the prediction of adverse events during the postoperative period will be established.",[26,90],"Complication",[64,92,65,93,94,95],"oncoplastic surgery","skin sparing mastectomy","nipple-skin sparing mastectomy","indocyanine color green","RECRUITING","2024-07-20",{"date":99,"type":39},"2024-07-23",{"date":101,"type":39},"2023-06-01",{"date":103,"type":20},"2025-07-31",{"name":105,"class":76},"University Hospital A Coruña",1]