This randomized phase II trial studies how well Alloderm (ready-to-use) RTU medium and Cortiva 1mm Allograft Dermis work in improving outcomes in patients after mastectomy. Alloderm RTU medium and Cortiva 1mm Allograft Dermis may improve safety, satisfaction, and cost in patients after mastectomy.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02891759.
PRIMARY OBJECTIVES:
I. To evaluate premature explantation of breast tissue expanders or immediate breast implants following acellular dermal matrix (ADM)-assisted immediate tissue expander breast reconstruction for patients receiving Alloderm RTU medium versus Cortiva 1mm Allograft Dermis.
SECONDARY OBJECTIVES:
I. To evaluate other complications and patient reported outcomes (as determined by the Breast Questionnaire [Q]) following pre- or postpectoral ADM-assisted immediate tissue expander or implant breast reconstruction for patients receiving Alloderm RTU medium versus Cortiva 1mm Allograft Dermis.
II. To evaluate physician reimbursement and direct hospital costs.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP A: Patients undergo standard of care skin-sparing or nipple sparing mastectomy and receive Alloderm RTU during surgery.
GROUP B: Patients undergo standard of care skin-sparing or nipple sparing mastectomy and receive Cortiva 1mm Allograft Dermis during surgery.
After completion of study, patients who received a prepectoral immediate implant are followed up for 3-6 months post-surgery, and all patients are followed up periodically for up to 15 months.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationSiteman Cancer Center at Washington University
Principal InvestigatorTerrence Myckatyn
