Chemically Assisted Capsulectomy-A New Clinical Approach

Implant Capsular Contracture Clinical Trial

Official title:

Chemically Assisted Capsulectomy-A New Clinical Approach

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00758667
• Other study ID #: 010518
• Status: Terminated
• Phase: N/A
• First received: September 23, 2008
• Last updated: December 8, 2014
• Start date: January 2005
• Est. completion date: December 2009

Study information

• Verified date: December 2014
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: December 2009
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• All females undergoing capsulectomy

Exclusion Criteria:

• All pregnant women and nursing mothers will be exclued

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Contracture
• Implant Capsular Contracture

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare Number of Patients With Capsular Contracture in Mesna Group vs Standard of Care		one year	No
Secondary	Compare Number of Patients With Adverse Events in the Mesna Group vs the Standard of Care		one year	Yes