Breast Reconstruction In One Stage

The aim of this study is to compare clinical outcomes and cost-effectiveness of two procedures for skin sparing mastectomy with implant reconstruction in a randomized clinical trial. The currently preferred two-stage breast reconstruction with implantation of a tissue expander during a first, and placement of a breast prosthesis during a second surgery will be compared to the novel one-stage immediate breast reconstruction, where implants are combined with a collagen matrix inlay (Strattice™).



The use of a collagen matrix in combination with definitive implants in immediate breast reconstruction after skin sparing mastectomy is a good one-stage alternative for the traditional two-stage procedure because we think it

I. has the same or a lower complication rate;

II. gives equal or a better cosmetic result;

III. is less painful to the patient;

IV. Is more cost-effective.

The follow-up moments will be arranged as following:

One-step procedure:

Surgery - 2 weeks post-op - 6 weeks – 3 months - 6 months – 12 months post-op.

Two-step procedure:

Tissue Expander - Fillings – Implant – 2 weeks – 6 weeks – 3 months - 6 months – 12 months post-op.

Patients whom are eligible for the study and give informed consent will be operated by a plastic surgeon. Skin sparing mastectomy and implant reconstruction will be performed in all patients. Patients will be randomized to treatment group 1 or 2 three days before the mastectomy. In treatment group 1 a tissue expander will be placed during a first surgery, and abreast prosthesis will be placed during a second surgery. In the time between the first and second surgery the tissue expander will be filled repeatedly.

In treatment group 2, patients will undergo a skin sparing mastectomy with immediate placement of a breast implant combined with a collagen matrix sheet (Strattice™).