SurgiMend® vs. Strattice™ in Direct to Implant Breast Reconstruction- A Prospective Randomized Trial

Introduction

An increasing number of Danish women undergo genetic counseling for hereditary breast cancer. If the patient´s lifetime risk is evaluated to be more than 30%, the patient may choose to undergo a risk-reducing mastectomy (prophylactic mastectomy) to reduce the risk of developing breast cancer. The mastectomy is mostly performed as a skin-sparing procedure, where only the nipple area and the breast tissue is removed leaving the skin envelope intact, in order to preserve the breast skin for an immediate breast reconstruction. In select cases the surgery may be performed as a nipple-sparing procedure. Additionally, there is an increasing group of women diagnosed with multifocal DCIS who choose risk-reducing mastectomy with an immediate reconstruction.

In order for the risk-reducing mastectomy to be effective, it is of utmost importance that all the breast tissue is removed. This leaves the skin flaps covering the breast thin and vulnerable to necrosis, if not handled with utmost care. In order to spare the mastectomy skin flaps of some of the strain and pressure caused by the breast implants, acellular dermal matrixes (ADM) are increasingly used in this type of procedures. ADMs are derived from the skin of humans or animals, processed to an extent where their cellular components are completely removed, leaving only the extracellular scaffold, thus not inciting an immune response from the host. The ADM thus provides a scaffold, promoting integration of the patient's own connective tissue. In time the ADM will be repopulated and revascularized by the patient's own cells, essentially becoming an integrated part of the patients body. The ADM provides optimal definition of the breast borders, essentially allowing improved implant positioning as compared with a sub muscular coverage technique. If the circumstance of the breast reconstructions necessitates the placement of an expander implant, use of ADMs allows for a greater intraoperative expansion, and thus subsequently reduces the number of times the patients must attend the outpatient's clinic for expansion of the implant. Thus leading to a shorter time before the expander implant may be exchanged for a permanent implant. Furthermore, several studies have shown that use of ADM lowers the overall complication rate.

Several types of ADM are used in a breast reconstructive setting around the world. Strattice™ is a porcine derived ADM, and has been available in Europe and Denmark since late 2008. In order to find the best available ADM for use in a immediate breast reconstructive setting, both in terms of complication rates and patient satisfaction, it is crucial that new products are continuously evaluated. SurgiMend®, another type of ADM, was recently introduced on the Danish market. SurgiMend® ADM is derived from fetal bovine dermis, and recent studies show that the use of SurgiMend® ADM is associated with a low early complication rate. Furthermore, a recent study provided evidence that ADM derived from bovine have a higher mechanical stress tolerance when compared to porcine derived ADM at equivalent thickness.

Aim