Status:
UNKNOWN
The Use of Botulinum Toxin A in Two-Stage Tissue Expander/ Implant Breast Reconstruction
Lead Sponsor:
University of British Columbia
Collaborating Sponsors:
Vancouver Coastal Health
Providence Health & Services
Conditions:
Breast Neoplasms
Neoplasms by Site
Eligibility:
FEMALE
21+ years
Phase:
PHASE4
Brief 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 reconstruc...
Detailed Description
Currently, there is level C evidence for the efficacy of Botox in the treatment of postoperative pain and muscle spasms in breast reconstruction patients. Additional high-level evidence is necessary t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2017
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT01427400
Start Date
October 1 2011
End Date
December 1 2017
Last Update
July 29 2016
Active Locations (2)
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1
Plastic, Reconstructive and Cosmetic Surgery
Surrey, British Columbia, Canada, V3V 1N1
2
Canada, British Columbia
Vancouver, British Columbia, Canada, V5Z 1M9