Botulinum Toxin A in Tissue Expander Breast Reconstruction: A Double-Blinded Randomized Controlled Trial

Location:

Rochester, Minn., Jacksonville, Fla., Phoenix/Scottsdale, Ariz.

Trial status:

Open for Enrollment

Why is this study being done?

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 randomized to receive either a single injection of 100 units of BTX-A, or a placebo (saline water), during surgery 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.

Who is eligible to participate?

Inclusion: 1. Women at least 18 years of age, who will undergo immediate unilateral or bilateral tissue expander breast reconstruction following therapeutic skin-sparing or nipple-sparing mastectomy. 2. Women at least 18 years of age, who will undergo immediate bilateral tissue expanders breast reconstruction following risk-reduction (prophylactic) skin-sparing or nipple-sparing mastectomy. Exclusion: 1. Subjects who are unable to read or speak English. 2. Breast reconstruction using the latissimus dorsi flap combined with a tissue expander. 3. Documented diagnosis of chronic pain, upper limb spasticity, cervical dystonia, axillary hyperhidrosis, strabismus or blepharospasm; 4. Hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation. 5. Infection at the proposed site of injection. 6. Pre-existing neuromuscular disorders (including diagnosed myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis). 7. Aminoglycosides intake at the time of surgery (these antibiotics can potentiate the effect of BTX-A). 8. Women who are pregnant or breast feeding. 9. Presence of submuscular implants from previous breast surgery. 10. Reported use of Botox within 4 months prior to planned surgical date.

Last updated:

2/17/2014

NCT ID:

NCT01591746

IRB Number:

11-001687