Neoplasms Clinical Trial
— BotoxOfficial title:
The Use of Botulinum Toxin-A in Two-stage Tissue Expander/Implant Breast Reconstruction: A Prospective, Randomized, Double-Blind Placebo Controlled Trial
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.
Status | Recruiting |
Enrollment | 128 |
Est. completion date | December 2017 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 21 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Plastic, Reconstructive and Cosmetic Surgery | Surrey | British Columbia |
Canada | Canada, British Columbia | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
University of British Columbia | Fraser Health, Providence Health & Services, Vancouver Coastal Health |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from Baseline in Quality of life and patient satisfaction using the Breast-Q | The Breast-Q© is a patient reported outcome measure (PROM) for breast surgery that was rigorously developed to accurately measure patient reported satisfaction and quality of life (QOL). (http://www.mskcc.org/mskcc/shared/Breast-Q/index.html). The BREAST-Q was developed and validated with adherence to international guidelines. This PROM is composed of six scales that address: 1) psychosocial well-being, 2) physical well-being, 3) sexual well-being, 4) satisfaction with breasts, 5) satisfaction with outcome, and 6) satisfaction with care. | Before 1st surgery, 2 weeks, ~6-8weeks, Before 2nd Surgery, 6 months, and 12 months post-op | No |
Secondary | Patient-reported pain,using the BPI (Brief Pain Inventory) and Pain Diary during the expansion phase (initial to final expansion) and in the long-term period (6 and 12 months). | The BPI is a common patient-reported instrument used to assess clinical pain. The BPI assesses the severity of pain and the impact of pain on daily functions in patients with pain from chronic diseases or conditions or acute conditions (i.e. postoperative pain). The question asked on the daily pain diary will be derived from the BPI: "Every evening at the same time, please rate the worst pain you've experienced in the last 24 hours when 0 represents no pain and 10 represents the most severe pain imaginable". |
BPI (before 1st surgery, day of surgery, 2 weeks, ~ 6 - 8 weeks, before 2nd surgery, 6 months and 12 months). After 1st surgery, pain diary is to be filled out every evening at the same time. | No |
Secondary | Aesthetic outcome | Aesthetic results can be evaluated using different methods: patient-reported aesthetic satisfaction (Breast-Q) and aesthetic outcome from the perspective of the health professional. Standardized photographs using a three-category, five-item Breast Aesthetic Score. This scoring scheme separates the various components of the aesthetic results of the breast into different subscale thus allowing the rating to be more explicit. This score has not been validated, but has demonstrated good inter- and intra-rater reliability. | 6 months and 12 months (after 2nd surgery) | No |
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