Breast Reconstruction With Acellular Dermal Matrix in the Setting of Breast Cancer Treatment

NACompletedINTERVENTIONAL
Enrollment

135

Participants

Timeline

Start Date

April 30, 2014

Primary Completion Date

April 30, 2017

Study Completion Date

May 31, 2017

Conditions
Breast Cancer
Interventions
PROCEDURE

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.

PROCEDURE

Skin or nipple sparing mastectomy

Mastectomy for invasive or pre-invasive breast cancer

PROCEDURE

Reconstruction with implant

Immediate breast reconstruction with implant

PROCEDURE

Total submuscular coverage

Implant based breast reconstruction with total submuscular coverage

PROCEDURE

Partial submuscular coverage

Implant based breast reconstruction with partial submuscular coverage

Trial Locations (5)

Unknown

Falun Hospital, Department of Breast Surgery, Falun

Capio S:t Gorans Hospital, Stockholm

Karolinska University Hospital, Stockholm

Södersjukhuset AB, Stockholm

Oxford University Hospitals, Oxford

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Karolinska Institutet

OTHER

collaborator

LifeCell

INDUSTRY

lead

Karolinska University Hospital

OTHER

NCT02061527 - Breast Reconstruction With Acellular Dermal Matrix in the Setting of Breast Cancer Treatment | Biotech Hunter | Biotech Hunter