The Use of Botulinum Toxin A in Two-Stage Tissue Expander/ Implant Breast Reconstruction

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

Breast reconstruction is a common procedure with over 86,000 breast reconstruction procedures performed in the United States in 2009. This is a 1.5-fold increase since 2007. Of these breast reconstructions, 65% use a tissue expander/implant technique. Although satisfactory results can be achieved with a single-stage technique, a two-stage approach is considered more reliable, allowing for precise positioning of the inframammary fold and an opportune time to perform a capsulotomy to increase the breast skin flap by releasing the soft tissue.

The placement of the tissue expander and implant under the chest muscles is thought to minimize the incidence of capsular contracture, expander exposure, and in addition, produce acceptable aesthetic results. However, discomfort is often associated with this submuscular placement of a tissue expander or implant, specifically during the expansion phase. Patients undergoing immediate reconstruction using submuscular implants have been shown to have higher analgesic requirements and to have higher pain scores post-operatively, compared to non-reconstructed patients. An uncomfortable reconstruction can lead to under-filling of the expander, a longer expansion process, abandonment of reconstruction, and a compromised quality of life. The use of Botulinum Toxin A (Botox) injections into the chest muscles at the time of surgery may help ease the discomfort that is often associated with this procedure.

The investigators propose a prospective double-blind randomized placebo-controlled trial of patients undergoing tissue expander/implant reconstruction. The information gathered from this analysis will provide a greater understanding of the effects of Botox in the setting of two-stage tissue expander/implant breast reconstruction, with the goal to improve patient satisfaction and quality of life.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of British Columbia
• Collaborators: Fraser Health; Providence Health & Services; Vancouver Coastal Health
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

Inclusion Criteria:

• Patients who undergo immediate, post-mastectomy, unilateral or bilateral, tissue expander/implant reconstruction

• Patients older than 21, with no upper age limit

• English-speaking, or has an appropriate translator

Exclusion Criteria:

• Patient declines inclusion in the study

• Patients who undergo a single-stage implant reconstruction or combined autogenous tissue expander/implant reconstruction

• Previous history of radiation

• Previous breast surgery with implants

• Previous history of axillary lymph node dissection

• Patients who are pregnant

• Patients with hepatorenal failure

• Patients with known hypersensitivity to Botulinum Toxin-A

• Patients with significant mastectomy flap ischemia at time of tissue expander placement