Skin sparing mastectomy with implant reconstruction: clinical outcomes and cost effectiveness of reconstruction in one stage with the use of a collagen matrix. A randomized clinical trial. - Skinsparing mastectomy with immediate implant reconstruction.

Vrije Universiteit Medisch Centrum0 个研究点目标入组 140 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

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•Female patients from the participating hospitals are included if they meet the following criteria: willing and able to participate; aged 18 and over; able to provide informed consent and to complete questionnaires. Women who meet the inclusion criteria are informed about the study by their doctor and recieve a patientletter. There will be the possibility to ask further questions. Patients are included after signing the informed consent.

•Exclusion criteria are: pregnancy or planning a pregnancy during the study; ongoing severe psychiatric illness or mental retardation; evidence of alcohol and/or drug abuse; inability to complete the questionnaires; local or general infection which could jeopardize the surgical objective; extensive local inflammatory reactions; proven or suspected hypersensitivity to materials; immunosuppressive pathologies

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