Chemically Assisted Capsulectomy-A New Clinical Approach

Vanderbilt University20 enrolled

Overview

The purpose of this study is to make available an agent,Mesna, which can assist the surgeon during the procedure of capsulectomy.

Mesna is a FDA approved drug for the treatment of respiratory diseases and is used a protective agent against drugs in oncology patients. It has also been used in Gynecologic surgery and ENT. Mesna is a drug that breaks down adhesions between tissue layers.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Implant Capsular Contracture

Interventions

MesnaDRUG

B. Mesna will be used to aid in the removal of the capsule when capsulectomy is performed

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * All females undergoing capsulectomy Exclusion Criteria: * All pregnant women and nursing mothers will be exclued

Outcomes

Primary Outcomes

Compare Number of Patients With Capsular Contracture in Mesna Group vs Standard of Care

Time frame: one year

Secondary Outcomes

Compare Number of Patients With Adverse Events in the Mesna Group vs the Standard of Care

Time frame: one year

Data from ClinicalTrials.gov

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