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

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

Interventions

DRUG

Botulinum Toxin-A

100 Units diluted in 25cc saline

DRUG

Saline

Dispensed in a 25cc syringe

Sponsors & Collaborators

• Vancouver Coastal Health

  collaborator OTHER_GOV

• Providence Health & Services

  collaborator OTHER

• Fraser Health

  collaborator OTHER

• University of British Columbia

  lead OTHER

Principal Investigators

• Adelyn Ho, MD, MPH · University of British Columbia

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-10-31

Primary Completion

2016-12-31

Completion

2017-12-31

Countries

• Canada

Study Locations