SEROMA REDUCTION IN MASTECTOMY
SAM Trial

Seroma formation is a common complication following mastectomy for invasive
breast cancer. Seroma formation can cause problems in wound healing and
infection and thus leading to repeated visits to the out-patient clinic.
Mastectomy flap fixation (FF) is achieved by reducing dead space volume using
interrupted subcutaneous sutures or by applying a tissue adhesive glue.

We hypothesized that obliteration of the dead space following mastectomy would
significantly reduce seroma formation and therefore seroma related wound
complications and patient discomfort (fewer seroma aspirations and fewer check
ups in the out patient clinic). This study will elucidate whether flap fixation
influences cosmetic outcome and shoulder function.

Prospective randomized trial, single blind study

1. Mastectomy with closed suction drainage and skin closure
2. Mastectomy with flap fixation using absorbable sutures and closed suction
drainage
3. Mastectomy with flap fixation using ARTISS tissue glue and closed suction
drainage

Patients will be informed about the study before inclusion in the out patient
clinic

Informed consent will be obtained in the out patient clinic a week after
patients were initially informed.

Postoperative check ups will de done more frequently.

Standard postoperative check ups:
2 weeks, 3 months, 12 months

Study postoperative check ups:
2 weeks, 6 weeks, 3 months, 6 months, 12 months

Therefore patients will be required to undergo two additional check ups.

During out patients visits, patients will hand in questionnaires regarding
shoulder function.

Patients will be clinically examined as they usually would be.