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

An increasing number of women undergo an immediate breast reconstruction, where the mastectomy and the breast reconstruction are performed in the same surgery. To aid survival of the mastectomy skin flaps, and to provide better aesthetic results acellular dermal matrixes (ADMs) are used to reinforce the breast. There are several different types of ADM available for this purpose. In this randomized clinical trial, the following study will investigate two different types of ADM (Strattice™ and SurgiMend®) in an immediate breast reconstructive setting. Sixty patients will be allocated on a 1:1 ratio to receive either Strattice™ or SurgiMend® ADM. Patients scheduled for immediate breast reconstruction with ADM at pt. of Plastic and Reconstructive Surgery at Aarhus University Hospital, Aarhus, Denmark will be offered participation. In total, 60 patients will be included. Outcome parameters of interest are complication rate, patient satisfaction, aesthetic result and cost of the procedure. Satisfaction and aesthetic result will be measured at 4 and 12 months post surgery.

Sex

Female

Minimum age

18 Years

Maximum age

80 Years

Inclusion Criteria:

* Patient has been deemed eligible for an immediate breast reconstruction using implant and ADM by the responsible plastic and breast surgeon
* Patient is older than 18 years of age
* Patient understand enough Danish to comprehend the given information and to complete the study questionnaires

Exclusion Criteria:

* Current smokers (patients not having paused for a minimum of four weeks prior to surgery)
* Non-eligible patients, as assessed by operating surgeon
* High level of co-morbidity, as assessed by operating surgeon or anesthesiologist

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