Chemically Assisted Capsulectomy-A New Clinical Approach

Not Applicable

Terminated

• Conditions: Implant Capsular Contracture
• Interventions: Drug: Mesna

• Registration Number: NCT00758667
• Lead Sponsor: Vanderbilt University

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2005-01
• Primary Completion: 2008-08
• Study First Submitted: 2008-09-23
• Study First Submitted QC: 2008-09-23
• Study First Posted: 2008-09-25
• Study Completion: 2009-12
• Results First Submitted: 2013-12-23
• Status Verified: 2014-12
• Results First Submitted QC: 2014-12-08
• Last Update Submitted: 2014-12-08
• Results First Posted: 2014-12-10
• Last Update Posted: 2014-12-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

• All females undergoing capsulectomy

Exclusion Criteria

• All pregnant women and nursing mothers will be exclued

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Use of Mesna	Mesna	Standard surgical procedure with Mesna

Primary Outcome Measures

Name	Time	Method
Compare Number of Patients With Capsular Contracture in Mesna Group vs Standard of Care	one year

Secondary Outcome Measures

Name	Time	Method
Compare Number of Patients With Adverse Events in the Mesna Group vs the Standard of Care	one year