Acellular Dermal Matrix in Tissue Expander Breast Reconstruction: A Prospective, Randomized, Clinical Trial Comparing SurgiMend PRS and AlloDerm
Purpose
After diagnosis of cancer, women often receive a mastectomy in which the breast tissue is removed. A device, called a tissue expander (AlloDerm, SurgiMend), is placed under the skin to allow the skin to grow and stretch prior to a breast implant (gel or saline). The purpose of this study is to assess and compare two currently used tissue expanders used during breast reconstruction surgery after mastectomy. The cost of these two products will also be compared.
Protocol Summary
This is a study in which patients requiring mastectomy and breast implants are recruited to participate. The patients will be randomly assigned to one of two groups, with half receiving the AlloDerm tissue expander and half receiving the SurgiMend.
Patients will undergo standard care for mastectomy and breast implant. Patients will have surgery (mastectomy) as prescribed by their doctor. One of the tissue expanders will be placed under the skin. The second surgery will then place the breast implant in the patient.
Patients will be asked to visit the plastic surgeon 2 weeks after the breast implant, monthly for 6 months and at 1 and 3 years after surgery. These visits will include a physical exam, medical history including medications and weight, forms asking the patient to rate her satisfaction with her surgery, and photographs of the breasts.
Eligibility Criteria
- Women ages 18 years and older
- Women who are will require a mastectomy and will have immediate breast reconstruction surgery