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.

Psychological outcome greatly improves when immediate breast reconstruction is
performed after mastectomy. The traditional method for breast reconstruction
after skin sparing mastectomy is a two-stage procedure where tissue expanders
are used as a first step and definitive implants are placed in a second
procedure. Each surgical procedure involves patient discomfort, multiple times
of tissue expander filling, health risks and costs. It is advantageous if
immediate breast reconstruction can be performed in a single procedure. Several
direct implant one-stage procedures are known. They either provide full muscle
coverage, with the disadvantage of high placement of prosthesis, needing
revision surgery, or they provide poor coverage in the lower portion of the
prosthesis. The use of a collagen matrix- an innovative approach in the
one-stage operation technique - solves this problem. The technique involves
insetting a sheet of collagen matrix between the infra mammary fold and the
inferior border of the pectoralis major which leads to precise control of the
inframammary fold, breast shape and lateral breast border. This results in a
complete coverage of the implant without resorting to additional muscle or
fascial elevation and better esthetical outcome. Collagen matrix can
successfully be used in conjunction with breast implants to achieve an
aesthetically pleasing result in one stage primary breast reconstruction,
providing good soft tissue cover at the time after. The use of a tissue
expander and its associated risks and costs are eliminated.

A novel one-stage procedure where definitive implants are combined with a
collagen matrix is compared to the traditional two-staged procedure where a
tissue expander is placed before an implant.
Our hypotheses are the following:
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
1. Has the same or a lower complication rate.
2. Gives equal or a better cosmetic result.
3. Is less painful to the patient.
4. Is more cost-effective.

The study is a prospective multicenter, single blinded, randomized controlled
clinical outcomes study. Randomization is stratified for all centers and
divided over time in blocks. A statistician will prepare the randomization in
advance. Before the operation is planned randomization takes place with closed
numbered envelopes. Four academic centers and three peripheral hospitals in
the Netherlands will participate coordinated by the principle investigator.

1. Two stage breast reconstruction after skin sparing mastectomy, with placing
of a tissue expander in the first, and implantation of a breast implant in the
second stage.
2. One stage immediate breast reconstruction where implants are combined with a
collagen matrix inlay.

The risk of complications will be comparable too the normal procedures. The
extra burden for the patient includes the completion of questionnaires at each
visit. The great benefit of participating in his study is that patients will be
monitored closely and therefore the surgeon can follow the post-operative time
closely. The big incentive for participating on the study is that women can
finish their treatment earlier and hopefully with a better esthetical outcome
only when randomized in the one stage procedure. The rest of the patients will
receive the standard surgical treatment and after care for their condition.