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Clinical Trials/NCT01765309
NCT01765309CompletedNot Applicable

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

University of Colorado, Denver2 sites in 1 country23 target enrollmentStarted: March 2009Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
23
Locations
2
Primary Endpoint
Difference between preoperative and postoperative pain scale
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Bilateral mastectomy with immediate tissue expander reconstruction

Exclusion Criteria

  • •Unwilling to receive study injections

Outcomes

Primary Outcomes

Difference between preoperative and postoperative pain scale

Time Frame: 12 weeks

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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