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A Randomized Controlled Trial To Evaluate The Use Of Botox In Breast Reconstruction With Tissue Expanders


N/A
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

A Randomized Controlled Trial To Evaluate The Use Of Botox In Breast Reconstruction With Tissue Expanders


Inclusion Criteria:



- Bilateral mastectomy with immediate tissue expander reconstruction

Exclusion Criteria:

- Unwilling to receive study injections

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Difference between preoperative and postoperative pain scale

Outcome Description:

Patients reported pain in each breast on a visual analog scale of 1-10 at each clinic visit

Outcome Time Frame:

12 weeks

Safety Issue:

No

Principal Investigator

Joyce K Aycock, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Colorado, Denver

Authority:

United States: Institutional Review Board

Study ID:

08-0782

NCT ID:

NCT01765309

Start Date:

March 2009

Completion Date:

July 2012

Related Keywords:

  • Breast Cancer
  • Tissue expanders
  • Botulinum toxin
  • Botox
  • Breast Neoplasms

Name

Location

University of ColoradoDenver, Colorado  80217