[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mammaplasty\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mammaplasty":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,41,75,101,125,145,167,196,226],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100430932","a-comparative-analysis-of-revolve-lipografter-and-viality-in-autologous-fat-grafting-during-breast-surgery-100430932",false,"NCT04891510","A Comparative Analysis of REVOLVE, LipoGrafter, and Viality in Autologous Fat Grafting During Breast Surgery","Inclusion Criteria:\n\n* Female;\n* Documented history of previous breast surgery (either complete or partial mastectomy);\n* Available harvest sites for fat grafting as documented by plastic surgeon;\n* BMI \\> 20;\n* Anticipated harvested fat volume \\> 50cc;\n* Competency and willingness to provide consent\n\nExclusion Criteria:\n\n* Suspected or known to be pregnant","FEMALE","18 Years",{"count":18,"type":19},135,"ESTIMATED","INTERVENTIONAL",[22],"NA","The purpose of this study is to learn whether there is a superior fat processing method in terms of graft retention in breast reconstruction after mastectomy.",[25,26,27],"Mastectomy","Mammaplasty","Breast Reconstruction","RECRUITING","2026-06-17",{"date":31,"type":32},"2026-06-22","ACTUAL",{"date":34,"type":32},"2021-05-19",{"date":36,"type":19},"2028-06-01",{"name":38,"class":39},"Weill Medical College of Cornell University","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":20,"phases":52,"briefSummary":53,"conditions":54,"keywords":59,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":40},"100641134","spsip-block-for-pain-control-after-breast-reduction-surgery-100641134","NCT07657949","SPSIP Block for Pain Control After Breast Reduction Surgery","Effect of Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block on Opioid Consumption After Reduction Mammaplasty: A Prospective Randomized Controlled Trial","SPSIP-RM","Inclusion Criteria:\n\n* Female participants aged 18 to 65 years\n* Scheduled for elective bilateral reduction mammaplasty\n* Planned surgery under general anesthesia\n* American Society of Anesthesiologists physical status class I to III\n* Planned postoperative clinical follow-up for the first 24 hours after surgery\n* Able to understand and report pain using the 0 to 10 Numeric Rating Scale\n* Able to provide written informed consent for study participation\n\nExclusion Criteria:\n\n* Known allergy or hypersensitivity to local anesthetic drugs\n* Contraindication to regional anesthesia or fascial plane block\n* Coagulopathy or clinically significant bleeding disorder\n* Use of anticoagulant or antiplatelet medication that prevents safe block application\n* Infection at the planned block injection site\n* Chronic opioid use, chronic pain syndrome, or regular analgesic use that may affect postoperative pain assessment\n* Revision breast surgery\n* Planned major additional surgical procedure other than reduction mammaplasty\n* Pregnancy or lactation\n* Unable to reliably report pain scores","65 Years",{"count":51,"type":19},80,[22],"The goal of this clinical trial is to learn whether an ultrasound-guided serratus posterior superior intercostal plane block (SPSIP block) can lower the need for opioid pain medicine after breast reduction surgery.\n\nThe main question it aims to answer is: Does adding an SPSIP block to standard anesthesia and pain treatment lower opioid use during the first 24 hours after surgery? Researchers will compare participants who receive standard anesthesia and pain treatment with participants who receive standard anesthesia and pain treatment plus an SPSIP block.\n\nParticipants will:\n\n* Have planned bilateral breast reduction surgery under general anesthesia\n* Be randomly assigned to the SPSIP block group or the control group\n* Receive standard local anesthetic infiltration during surgery and standard pain treatment after surgery\n* Have their pain score and pain medicine use recorded during the first 24 hours after surgery\n* Be followed for safety and complications for 30 days after surgery",[55,26,56,57,58],"Postoperative Pain Breast Reduction","Analgesia","Nerve Block","Opioid Consumption, Postoperative",[60,61,62,63,64],"Serratus posterior superior intercostal plane block","Ultrasound-guided regional anesthesia","Reduction mammaplasty","Breast reduction surgery","Postoperative pain","NOT_YET_RECRUITING","2026-06-14",{"date":68,"type":32},"2026-06-18",{"date":70,"type":19},"2026-08-01",{"date":72,"type":19},"2027-08-31",{"name":74,"class":39},"Cumhuriyet University Hospital",{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":49,"enrollmentInfo":82,"targetDuration":84,"studyType":85,"phases":4,"briefSummary":86,"conditions":87,"keywords":91,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":96,"startDateStruct":97,"completionDateStruct":98,"leadSponsor":100,"locationsCount":40},"100641052","autologous-free-dermal-graft-support-in-superior-pedicle-vertical-scar-reduction-mammaplasty-100641052","NCT07657962","Autologous Free Dermal Graft Support in Superior Pedicle Vertical Scar Reduction Mammaplasty","Effect of Autologous Free Dermal Graft Use on Lower Pole Stability in Superior Pedicle Vertical Scar Reduction Mammaplasty: A Prospective Comparative Cohort Study","Inclusion Criteria:\n\n* Female participants aged 18 to 65 years\n* Planned primary bilateral reduction mammaplasty\n* Planned use of the superior pedicle vertical scar technique\n* Willingness to attend at least 6 months of postoperative follow-up\n* Ability to provide written informed consent\n* Consent for standardized medical photography and clinical breast measurements\n\nExclusion Criteria:\n\n* Previous breast surgery\n* Oncoplastic breast reduction\n* Unilateral reduction mammaplasty\n* Use of a pedicle technique other than the superior pedicle\n* Use of a scar pattern other than the vertical scar pattern\n* Presence of a systemic condition expected to significantly impair wound healing\n* Active smoking within the last 6 weeks before surgery\n* Incomplete 6-month follow-up data for the primary outcome analysis",{"count":83,"type":19},70,"6 Months","OBSERVATIONAL","The goal of this observational study is to learn whether using an autologous free dermal graft during breast reduction surgery helps maintain lower breast pole shape over time in women undergoing primary bilateral reduction mammaplasty.\n\nThe main question it aims to answer is:\n\nDoes autologous free dermal graft support reduce lower pole lengthening between 1 month and 6 months after surgery?\n\nResearchers will compare two groups of participants. One group will undergo superior pedicle vertical scar reduction mammaplasty with autologous free dermal graft support as part of routine surgical care. The other group will undergo the same basic breast reduction technique without autologous free dermal graft support.\n\nParticipants will:\n\n* Have their planned breast reduction surgery as part of routine care\n* Attend postoperative follow-up visits at 1, 3, and 6 months\n* Have standard breast measurements and medical photographs taken during follow-up\n* Complete a breast satisfaction questionnaire at 6 months",[88,26,89,90],"Breast Ptosis","Lower Pole Elongation","Postoperative Breast Pseudoptosis",[62,92,93,94,95],"Superior pedicle","Autologous free dermal graft","Vertical scar reduction mammaplasty","Aesthetic outcome",{"date":68,"type":32},{"date":70,"type":19},{"date":99,"type":19},"2028-02-01",{"name":74,"class":39},{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":108,"enrollmentInfo":109,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":111,"conditions":112,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":124},"100555293","the-study-is-an-observational-post-market-follow-up-program-to-evaluate-long-term-5-years-safety-of-mentor-breast-implants-in-chinese-population-100555293","NCT06510205","The Study is an Observational Post-market Follow-up Program to Evaluate Long Term (5 Years) Safety of Mentor Breast Implants in Chinese Population","MNT202401: Post Market Clinical Follow up for Mentor Breast Implants","Inclusion Criteria:\n\n1. Women who have received Mentor breast implants per product instructions;\n2. Participants must possess the ability to comprehend the study procedures, give consent for the use of their preoperative and surgical data, and agree to take part in postoperative follow-up assessments. Additionally, they should possess the necessary civil capacity, be capable of reading and writing, and willingly provide informed consent by signing the consent form.\n3. Aged not less than 18 years at the time of implantation surgery (for products with registration license Guoxie Zhujin 20223130323, the participant's age should be not less than 22 years).\n\nExclusion Criteria:\n\n* Not applicable","100 Years",{"count":110,"type":19},6111,"The Mentor Post-Market Clinical Follow-Up Study is a multicenter observational study conducted in China. It aims to collect safety data on Mentor breast implants over a 5-year follow-up period in the Chinese population. In addition to safety data, the study will also gather information on postoperative pain and participant satisfaction levels. The objective is to explore customers' clinical experiences and use them as a reference for future product development. The study intends to enroll different number of participants for each license.",[113,26],"Breast Augmentation","2026-06-11",{"date":116,"type":32},"2026-06-15",{"date":118,"type":32},"2024-07-14",{"date":120,"type":19},"2034-12-31",{"name":122,"class":123},"Johnson & Johnson Medical (Shanghai) Ltd.","INDUSTRY",3,{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":134,"conditions":135,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":4},"100637888","custom-breast-implants-with-3d-imaging-100637888","NCT07628517","Custom Breast Implants With 3D Imaging","Personalized Breast Implant Modeling Using Imaging Techniques (MRI and Vectra)","Inclusion Criteria:\n\n* The targeted patients will be those undergoing mastectomy following neoadjuvant chemotherapy, prophylactically, or in the context of lobular cancer.",{"count":133,"type":19},25,"The aim of this study is to use MRI and Vectra metadata from patients in order to develop the \"customizable\" aspect of the MyBREAST One implant through computer modeling of this implant based on the collected metadata.",[26,27],"2026-06-04",{"date":138,"type":32},"2026-06-05",{"date":140,"type":19},"2026-05-18",{"date":142,"type":19},"2027-04",{"name":144,"class":39},"HELMo Link asbl",{"id":146,"slug":147,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":149,"acronym":4,"eligibilityCriteria":150,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":151,"enrollmentInfo":152,"targetDuration":4,"studyType":20,"phases":154,"briefSummary":155,"conditions":156,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":166},"100304262","electrical-stimulation-for-improving-postoperative-breast-sensation-100304262","NCT03240900","Electrical Stimulation for Improving Postoperative Breast Sensation","Inclusion Criteria:\n\n* Woman aged 18-60 undergoing bilateral, prophylactic nipple\u002Fskin-sparing mastectomy with immediate implant reconstruction\n\nExclusion Criteria:\n\n* Smokers\n* Preexisting peripheral neuropathy\n* Prior breast surgery","60 Years",{"count":153,"type":19},30,[22],"Described as the \"Angelina Jolie Effect\", rates of prophylactic mastectomy with immediate implant-based reconstruction are increasing dramatically as more women with genetic predisposition towards breast cancer are seeking surgical prevention. Advances in surgical techniques allow for the creation of an aesthetically pleasing postoperative breast mound; however, a common complaint is the lack of sensation to the skin and nipple of the reconstructed breast due to injury and stretch of the sensory nerves. Numbness of the breast, nipple, and areola is an unnatural feeling for the patient, as well as a potential risk for injury or burns as the woman is unable to feel pain.\n\nOur laboratory has previously shown that electrical stimulation (ES) is an effective way of improving nerve regeneration after injury to the nerves of the upper and lower extremities. Proven to improve motor outcomes following carpal and cubital tunnel release and sensation following injury to the digital nerves, this technique is a likely mechanism of restoring sensation of the breast as well.\n\nIn this study, we will follow thirty women undergoing prophylactic skin-sparing mastectomy with immediate implant-based reconstruction. At the time of surgery, patients will be randomly assigned ES to either the right or left breast. That breast will be reconstructed first and stimulated for one hour while the other breast is reconstructed. At the completion of the case, all wires will be removed. We will test sensation (tactile, temperature, 2-point discrimination, sharp\u002Fdull discrimination, and protective sensation) prior to surgery then again at 6, 12, 18, and 24 months following surgery to evaluate the effects of ES on sensory return. Patients will be provided with a survey to assess return of erogenous sensation.",[26],"2026-02-04",{"date":159,"type":32},"2026-02-06",{"date":161,"type":19},"2027-09-01",{"date":163,"type":19},"2028-11-30",{"name":165,"class":39},"University of Alberta",2,{"id":168,"slug":169,"hasResults":11,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":4,"eligibilityCriteria":173,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":174,"targetDuration":4,"studyType":20,"phases":176,"briefSummary":177,"conditions":178,"keywords":181,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":193,"locationsCount":195},"100527320","motiva-flora-aesthetic-breast-recon-clinical-study-100527320","NCT06146231","Motiva Flora® Aesthetic Breast Recon® Clinical Study","Motiva Flora® Tissue Expander as a Support for the Creation of an Autologous Adipose Matrix for Hybrid Breast Reconstruction: a Pivotal Study","Inclusion Criteria:\n\n1. Genetically female, aged 18 years or older.\n2. Subjects who had provided written informed consent form.\n3. The participant needs tissue expansion as part of breast reconstruction treatment, which may include immediate reconstruction.\n4. Clinical condition to allow reverse expansion breast reconstruction, at the investigator's discretion.\n5. Sufficient fat in donor sites (abdomen, gluteus, hips, and thighs) per plastic surgeon criteria.\n6. Complete radiotherapy and chemotherapy at least one year before surgery.\n7. BMI between 18.5 and 30.0 (average classified weight).\n8. Physical and cognitive capacity to understand and follow the surgeon's recommendations.\n9. To be able and willing to comply with all study requirements, including attending follow-up appointments.\n\n   Only Sub study participants\n10. Provide additional consent to undergo an MRI with contrast.\n\nExclusion Criteria:\n\n1. Current pregnancy or lactation, or full-term pregnancy or lactation at any point during the clinical investigation.\n2. Abnormal hematological and biochemical values after chemotherapy.\n3. High surgical risk according to the investigator.\n4. Breast width larger than 18 cm\n5. Tumor residues in or near the area where tissue expansion is performed.\n6. Subjects with metastatic breast cancer\n7. Significant Breast ptosis or poor skin quality\n8. Participants who do not have adequate tissue at the intended site for expansion, at the surgeon's discretion, due to previous radiotherapy, ulceration, vascular involvement, history of impaired wound healing, or mastectomy scar deformity.\n9. Inadequate chest wall tissue due to damage caused by radiotherapy, tight skin grafts, or radical resection of the pectoralis major muscle.\n10. Current or previous infection in the area where the expansion occurs.\n11. Any condition that impedes magnetic resonance imaging (MRI), including implanted metal device, claustrophobia, or other ailments that would prohibit MRI scan.\n12. Presence of autoimmune diseases such as lupus or scleroderma, or immunocompromised participants due to immunosuppressive or steroid therapy.\n13. History of silicone sensitivity.\n14. Active smokers\n15. Previous attempts of breast reconstruction\n16. Subjects who, in the opinion of the investigator, are considered part of any vulnerable population\n17. Subjects with affiliation to the Sponsor, sites or investigators, including relatives.\n18. Participants who do not live in the procedure's country make it impossible to assist in follow-up visits.\n19. Subjects who are participating in other investigation(s) which may affect the outcomes or ability to comply follow-up requirements of this study",{"count":175,"type":19},66,[22],"The present study will be based on a hybrid breast reconstruction approach with initial skin expansion using the Motiva Flora® Tissue Expander followed by a serial fat grafting session and a final step that includes the placement of a permanent breast implant Ergonomix2®.",[26,179,180],"Breast Cancer","Poland Syndrome",[182,183,184,185,186],"Reverse expansion","Aesthetic BreastRecon™","Hybrid breast reconstruction","Implant","Autologous tissue","2025-11-21",{"date":189,"type":32},"2025-11-26",{"date":191,"type":32},"2023-08-18",{"date":142,"type":19},{"name":194,"class":123},"Establishment Labs",4,{"id":197,"slug":198,"hasResults":11,"nctId":199,"briefTitle":200,"officialTitle":201,"acronym":4,"eligibilityCriteria":202,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":203,"targetDuration":4,"studyType":20,"phases":205,"briefSummary":206,"conditions":207,"keywords":212,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":40},"100571838","npwt-reduction-mammaplasty-100571838","NCT06725459","NPWT Reduction Mammaplasty","Assessing the Application of Closed Incision Negative Pressure Wound Therapy to Reduction Mammaplasty","Inclusion Criteria:\n\n* Female patients\n* Age 18 years or older\n* Scheduled to undergo bilateral reduction mammaplasty with a Wise pattern (anchor) incision and a superomedial, inferior, or central mound pedicle at MedStar Georgetown University Hospital or MedStar Good Samaritan Hospital\n* Able to comply with study procedures and follow-up visits\n\nExclusion Criteria:\n\n* Younger than 18 years of age\n* Biologically male patients\n* Scheduled to undergo unilateral breast mammaplasty\n* Currently pregnant or lactating\n* Use of steroids or other immune modulators known to affect wound healing\n* Current smokers who have not paused for a minimum of 4 weeks prior to surgery\n* History of breast cancer\n* History of oncologic or reconstructive breast surgery\n* History of radiation to the breast\n* History of chemotherapy or hormone therapy\n* Tattoos in the area of skin incision\n* Skin conditions known to affect wound healing or scarring of the breast (e.g., cutis laxa)\n* Significant history of scar problems (e.g., hypertrophic scarring or keloids) post-surgical incisions with active bleeding\n* Exposure of blood vessels, organs, bone, or tendon at the base of the reference wound\n* Known allergies to product components (e.g., medical or NPWT tape)\n* Unable to comply with NPWT requirements, including those unable to present for postoperative follow-up\n* Lactating at the time of surgery\n* Require deviation from standard operative or closure techniques (e.g., staples, free nipple grafts)\n* Considered part of a vulnerable population (adults unable to consent, infants, children, teenagers, pregnant women, prisoners)\n* Experience intraoperative complications due to surgical complications not related to the NPWT instrumentation (e.g., expanding hematoma)",{"count":204,"type":19},92,[22],"In this prospective, randomized, split-body control trial, we aim to compare complications, patient-reported outcomes, and cost differentials following reduction mammaplasty with prophylactic closed incision negative pressure wound therapy versus standard adhesive dressing.",[208,209,210,26,211],"Healthy","Macromastia","Negative Pressure Therapy","Wound Healing",[213,214,215,216],"mammaplasty","macromastia","breast reduction","negative pressure therapy","2025-10-24",{"date":219,"type":32},"2025-10-27",{"date":221,"type":32},"2024-12-17",{"date":223,"type":19},"2026-11-01",{"name":225,"class":39},"Medstar Health Research Institute",{"id":227,"slug":228,"hasResults":11,"nctId":229,"briefTitle":230,"officialTitle":230,"acronym":231,"eligibilityCriteria":232,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":233,"targetDuration":4,"studyType":20,"phases":235,"briefSummary":236,"conditions":237,"keywords":249,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":40},"100593584","impact-of-nipple-reconstruction-in-mastectomized-patients-using-cross-linked-hyaluronic-acid-injection-100593584","NCT07008339","Impact of Nipple Reconstruction in Mastectomized Patients Using Cross-Linked Hyaluronic Acid Injection.","RECHIAL","* Quantitative Phase\n* Inclusion Criteria:\n\nWomen over 18 years of age, or with parental or legal guardian consent.\n\nAt least one of the following criteria:\n\nWomen undergoing their first nipple-areola complex (NAC) reconstruction through micropigmentation and\u002For:\n\nNo previous neo-nipple surgery, either unilaterally or bilaterally.\n\nSurgical reconstruction of the areola.\n\nSurgical reconstruction of the NAC with subsequent retraction of the neo-nipple.\n\nMore than 6 months since their last surgery.\n\n\\- Exclusion Criteria:\n\nAllergy to hyaluronic acid.\n\nPoor tolerance to needle injections.\n\nWithdrawal Criteria:\n\nParticipant's voluntary decision.\n\nComplications associated with the technique (allergy, hematoma, etc.).\n\nClinical deterioration preventing the woman from continuing in the study.\n\n\\- Qualitative Phase\n\nParticipant Profile Characteristics: For the qualitative phase, women who have received NAC reconstruction with HA will be invited to participate, following the maximum variation criterion. To ensure the inclusion of participants with diverse characteristics and capture a wide range of perspectives and experiences on the phenomenon under study, women of varying ages, with different breast cancer diagnoses, and histories of various oncological, surgical, and therapeutic treatments will be selected.",{"count":234,"type":19},138,[22],"This study evaluates the impact of hyaluronic acid (HA) injection for nipple projection following mastectomy, as a complement to areola micropigmentation. While micropigmentation is standard in nipple-areola complex (NAC) reconstruction, HA use remains novel, with limited data on psychosocial, sexual, and aesthetic outcomes.\n\nA sequential explanatory mixed-methods design will be used. In Phase 1, a randomized controlled trial will compare two groups: one receiving NAC micropigmentation alone (control) and the other receiving micropigmentation plus HA-based nipple projection (intervention). A total of 138 participants will be recruited at the Areolar Micropigmentation Unit of Germans Trias i Pujol University Hospital (Barcelona) over 36 months. Outcomes will include psychosocial and sexual well-being, satisfaction with breast and nipple appearance, and nipple projection, measured using the Spanish BREAST-Q, a custom satisfaction tool, and calipers.\n\nPhase 2 will involve a qualitative phenomenological study using semi-structured interviews with a purposive sample from the intervention group. Thematic analysis will explore body image, emotional and social well-being, and overall satisfaction, using NVivo software.\n\nThis is the first study assessing HA nipple reconstruction by advanced practice nurses using validated patient-reported outcomes. While the BREAST-Q is appropriate, it may not fully capture emotional nuances, justifying qualitative exploration. HA durability is estimated at 6-9 months, but residual volume and satisfaction over time remain underexplored. HA's aesthetic footprint may allow reduced dosages in future applications.\n\nThis minimally invasive technique may reduce the need for surgical nipple reconstruction. Conducting the procedure in a nurse-led setting is novel and may enhance patient-centered care and the role of nursing in post-mastectomy recovery.\n\nThe study complies with the Declaration of Helsinki and Spanish biomedical regulations. Ethical approval was obtained. Participants will provide informed consent, and data will be anonymized and securely stored.",[238,25,26,239,240,241,242,243,244,245,246,247,27,248],"Breast Neoplasms","Nipple Disorder","Tattooing","Hyaluronic Acid","Dermal Fillers","Reconstructive Surgical Procedures","Quality of Life","Self Concept","Body Image","Patient Satisfaction","Nipple Reconstruction",[179,25,27,250,248,251,241,242,252,240,246,244,253,254,247,255],"Nipple-Areola Complex Reconstruction","Areola Reconstruction","Micropigmentation","Postmastectomy Reconstruction","Cross-linked Hyaluronic Acid","Breast Cancer Survivors","2025-06-04",{"date":258,"type":32},"2025-06-06",{"date":260,"type":32},"2023-06-02",{"date":262,"type":19},"2029-07-02",{"name":264,"class":39},"Germans Trias i Pujol Hospital"]