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:
Participant gender:
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
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