Recruiting

Botulinum Toxin A

Sponsor:

University of British Columbia

Code:

NCT01427400

Conditions

Breast Neoplasms

Neoplasms by Site

Neoplasms

Breast Diseases

Skin Diseases

Eligibility Criteria

Sex: Female

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Botulinum Toxin-A

Saline

Study Details

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 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.

Conditions

Breast Neoplasms

Neoplasms by Site

Neoplasms

Breast Diseases

Skin Diseases

Study ID

NCT01427400

Start date

Oct, 2011

Status verified date

Jul, 2016

Completion date

Dec, 2017

Anticipated

Primary completion date

Dec, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 21+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

128 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Expander Placement, Botulinum Toxin-A

During surgery, administered only once, 5 cc in 5 different locations on chest muscle.

placebo comparator: Tissue expander Placement WITH Saline

During surgery, administered only once, 5 cc in 5 different locations on chest muscle.

Interventions

Botulinum Toxin-A

100 Units diluted in 25cc saline

Saline

Dispensed in a 25cc syringe

Primary outcome measure

  • Change from Baseline in Quality of life and patient satisfaction using the Breast-Q [ Time Frame: Before 1st surgery, 2 weeks, ~6-8weeks, Before 2nd Surgery, 6 months, and 12 months post-op ]

Central Contacts and Locations

Central contacts

Locations

Plastic, Reconstructive and Cosmetic Surgery

Recruiting

Surrey, British Columbia, Canada, V3V 1N1

Canada, British Columbia

Recruiting

Vancouver, British Columbia, Canada, V5Z 1M9

Contacts

Principal Investigator:

Sheina A Macadam, MD FRCSC MHS

More Information

Sponsor

University of British Columbia

Last update posted

Jul 29, 2016

Last verified

Jul, 2016

Keywords

  • Breast expander
  • Breast reconstruction
  • Implants
  • Botox

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2016-07-29.