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

NCT01427400 | Unknown Phase 4

• 1 other identifier: H10-03166
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 2

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

Keywords

Breast expander; Breast reconstruction; Implants; Botox

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• 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).

  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.

• Aesthetic outcome

  6 months and 12 months (after 2nd surgery)

Study Arms (2)

Expander Placement, Botulinum Toxin-A

EXPERIMENTAL

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

Drug: Botulinum Toxin-A

Tissue expander Placement WITH Saline

PLACEBO COMPARATOR

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

Drug: Saline

Interventions

Botulinum Toxin-A DRUG

100 Units diluted in 25cc saline

Also known as: Botulinum Toxin Type A

Expander Placement, Botulinum Toxin-A

Saline DRUG

Dispensed in a 25cc syringe

Also known as: 0.9% Sodium Chloride

Tissue expander Placement WITH Saline

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead
• Vancouver Coastal Health: collaborator
• Providence Health & Services: collaborator
• Fraser Health: collaborator

Study Sites (2)

Plastic, Reconstructive and Cosmetic Surgery

Surrey, British Columbia, V3V 1N1, Canada

RECRUITING

Canada, British Columbia

Vancouver, British Columbia, V5Z 1M9, Canada

RECRUITING

Related Links

• UBC Division of Plastic Surgery
• Canadian Breast Cancer Foundation

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases

Interventions

Botulinum Toxins, Type A; Sodium Chloride

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Adelyn Ho, MD, MPH

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adelyn L Ho, MD MPH

CONTACT

604-773-5466; adelynh@interchange.ubc.ca

Joline T Choi, MBBS, MHS

CONTACT

604-875-4111; joline.choi@vch.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2011
• First Posted: September 1, 2011
• Study Start: October 1, 2011
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: July 29, 2016

Record last verified: 2016-07

Locations

CA (2)