[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"nipple-disorder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:nipple-disorder":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":40,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":50,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":57,"locationsCount":5},"100593584","impact-of-nipple-reconstruction-in-mastectomized-patients-using-cross-linked-hyaluronic-acid-injection-100593584",false,"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.","FEMALE","18 Years",{"count":19,"type":20},138,"ESTIMATED","INTERVENTIONAL",[23],"NA","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.",[26,27,28,29,30,31,32,33,34,35,36,37,38,39],"Breast Neoplasms","Mastectomy","Mammaplasty","Nipple Disorder","Tattooing","Hyaluronic Acid","Dermal Fillers","Reconstructive Surgical Procedures","Quality of Life","Self Concept","Body Image","Patient Satisfaction","Breast Reconstruction","Nipple Reconstruction",[41,27,38,42,39,43,31,32,44,30,36,34,45,46,37,47],"Breast Cancer","Nipple-Areola Complex Reconstruction","Areola Reconstruction","Micropigmentation","Postmastectomy Reconstruction","Cross-linked Hyaluronic Acid","Breast Cancer Survivors","RECRUITING","2025-06-04",{"date":51,"type":52},"2025-06-06","ACTUAL",{"date":54,"type":52},"2023-06-02",{"date":56,"type":20},"2029-07-02",{"name":58,"class":59},"Germans Trias i Pujol Hospital","OTHER"]