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

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Breast Cancer

Treatments: Procedure: Bilateral mastectomy with reconstruction

Study type: Interventional

Funder types: Other

Identifiers

NCT01765309

08-0782

Details and patient eligibility

About

Investigation of whether injection of the pectoralis muscle with 100 units botulinum toxin during breast reconstruction with tissue expanders results in decreased pain using a blinded, randomized, controlled trial.

Enrollment: 23 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Bilateral mastectomy with immediate tissue expander reconstruction

Exclusion criteria

• Unwilling to receive study injections

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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23 participants in 1 patient group

Bilateral mastectomy with reconstruction

Experimental group

Description:

The trial was a comparison between each breast in a single patient undergoing bilateral mastectomy with reconstruction

Treatment:

Procedure: Bilateral mastectomy with reconstruction