135
Participants
Start Date
April 30, 2014
Primary Completion Date
April 30, 2017
Study Completion Date
May 31, 2017
Reconstruction with ADM.
If the patient wishes to undergo immediate implant based reconstruction, and meets the selection criteria for entering the study, she is randomly selected to be treated according to Group A or Group B. Group A (no intervention) will be reconstructed with expander or anatomical gel implant without ADM, using complete muscle coverage. Group B (Intervention) will be reconstructed with expander or anatomical gel implant using partial muscle coverage in conjunction with ADM.
Skin or nipple sparing mastectomy
Mastectomy for invasive or pre-invasive breast cancer
Reconstruction with implant
Immediate breast reconstruction with implant
Total submuscular coverage
Implant based breast reconstruction with total submuscular coverage
Partial submuscular coverage
Implant based breast reconstruction with partial submuscular coverage
Falun Hospital, Department of Breast Surgery, Falun
Capio S:t Gorans Hospital, Stockholm
Karolinska University Hospital, Stockholm
Södersjukhuset AB, Stockholm
Oxford University Hospitals, Oxford
Collaborators (1)
Karolinska Institutet
OTHER
LifeCell
INDUSTRY
Karolinska University Hospital
OTHER