Botulinum Toxin A in Tissue Expander Breast Reconstruction: A Double-Blinded Randomized Controlled Trial
Consecutively enrolled eligible women will be randomized into one of two different treatment
groups: 1) Group receiving BTX-A, and 2) Group receiving a placebo. All consenting subjects
will be assigned to receive during surgery either a single injection of 100 units of BTX-A,
or a placebo (saline water), in the pectoralis major muscle on the operated side once the
mastectomy and the breast reconstruction have been completed. Expected duration of subject
participation is up to 12 months, depending on the number of tissue expansion visits
necessary to fill the tissue expander to its final desired volume.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Change from Baseline in average pain scores using a numeric pain intensity scale
The numeric pain intensity scale (NPIS) will be completed at various time frames. The NPIS is a visual analog scale commonly used to assess clinical pain.
Pre-operatively, post-opeartively: at 1 week, 2 weeks, at every expansion, at 3 months, and at the follow-up visit prior to the second surgery
Valerie Lemaine, MD
United States: Food and Drug Administration
|Mayo Clinic||Rochester, Minnesota 55905|