This clinical trial tests the safety and ability of patient performed breast tissue expansion at home. Tissue expansion typically requires patients to travel and attend multiple clinic visits so that their tissue expanders can be filled in the clinic. Using this method patients may be able to learn how to safely do their own tissue expansions at home, which may save time and resources due to fewer clinic visits.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04781907.
PRIMARY OBJECTIVES:
I. Evaluate overall treatment success in undergoing alloplastic breast reconstruction.
II. Evaluate profile and rate of complications in patients performing tissue expansions at home.
SECONDARY OBJECTIVES:
I. For patients with bilateral tissue expanders, compare treatment success and complication profile/rate of right and left breast.
II. Compare treatment success and complication profile/rate of patients who perform some tissue expansions at home versus (vs) patients who have all tissue expansions performed by clinical staff.
EXPLORATORY OBJECTIVE:
I. Evaluate patient’s satisfaction in experience of learning and performing expansions at home.
OUTLINE: Patients choose to participate in 1 of 2 arms.
ARM I: Patients perform saline injection into the right breast tissue expander under clinic staff supervision and guidance at the second and third tissue expansion visit. Clinic staff perform saline injection into the left breast tissue expander at second and third expansion visits. Beginning at fourth tissue expansion time, patients perform saline injection into the right side at home prior to clinic visit and will have saline injection performed on the left side by clinic staff.
ARM II: Patients receive usual care.
After completion of study treatment, patients are followed up at 2 weeks after surgery and up to 6 months.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationUniversity of Wisconsin Carbone Cancer Center - University Hospital
Principal InvestigatorSamuel Poore
