Clinical Trial: Chemically Assisted Capsulectomy-A New Clinical Approach

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Chemically Assisted Capsulectomy-A New Clinical Approach

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 Summary: 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.
Sponsor: Vanderbilt University

Current Primary Outcome: Compare Number of Patients With Capsular Contracture in Mesna Group vs Standard of Care [ Time Frame: one year ]

Original Primary Outcome: Evaluate the safety and efficacy of Mesna as an agent for chemically assisted capsulectomies [ Time Frame: one year ]

Current Secondary Outcome: Compare Number of Patients With Adverse Events in the Mesna Group vs the Standard of Care [ Time Frame: one year ]

Original Secondary Outcome: To compare capsular contracture rates between the control and the Mesna group one year after surgery [ Time Frame: one year ]

Information By: Vanderbilt University

Dates:
Date Received: September 23, 2008
Date Started: January 2005
Date Completion:
Last Updated: December 8, 2014
Last Verified: December 2014