DUGi

Efficacy, safety, and patient satisfaction in subpectoral breast reconstruction with Acellular Dermal Matrix: a prospective clinical trial

http://dugi.udg.edu/item/http:@@@@hdl.handle.net@@10256@@28509

BACKGROUND : Breast cancer is the most diagnosed cancer and the leading cause of cancer-related death among women worldwide, with an incidence of over 2 million cases annually. In the Girona region, more than 500 cases are diagnosed each year. Surgical treatment, including breast-conserving surgery or mastectomy, remains a cornerstone of management. Post-mastectomy breast reconstruction is essential for improving patients’ quality of life and can be achieved through heterologous (implant-based) or autologous (tissue flap) techniques. OBJECTIVES : the primary objective of this study is to compare the patient satisfaction and quality of life between subpectoral implant-based breast reconstruction with and without using an Acellular Dermal Matrix. Secondary objectives include evaluating the incidence of postoperative minor and major complications, assessing the objective aesthetic results by an expert panel and the total costs of the surgeries and the process. DESIGN : This is a study designed as a multicentre, prospective, randomized, assessor-blind, parallel-group clinical trial that includes patients undergoing implant-based breast reconstruction after a mastectomy due to breast cancer. METHODS : A total of 158 patients scheduled for immediate post-mastectomy breast reconstruction will be recruited from participating hospitals using consecutive sampling. Participants will be randomly assigned (1:1) to either the intervention group (subpectoral reconstruction with Acellular Dermal Matrix) or the control group (standard subpectoral reconstruction). Data will be collected in the immediate postoperative period, during the hospital stay, and up to 24 months post reconstructive surgery. The main outcome variable will be patients’ satisfaction and quality of life, which will be assessed at 6, 12 and 24 months after surgery using the BREAST-Q questionnaire. Patients will be followed for 2 years; complications will be evaluated at each visit, capsular contracture and the objective aesthetic result will be assessed at the same time as the questionnaire. At the end of the follow-up, the overall economic costs will be calculated. All data on study variables and covariables will be collected and analysed to determine their statistical significance. The total duration of the study is estimated to be 5 years

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