Back to resultsChemically Assisted Capsulectomy-A New Clinical Approach
Primary Purpose
Implant Capsular Contracture
Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mesna
Sponsored by
About this trial
This is an interventional treatment trial for Implant Capsular Contracture focused on measuring capsular contracture, capsulectomy, mesna, Capsular contracture after breast implant placement
Eligibility Criteria
Inclusion Criteria:
- All females undergoing capsulectomy
Exclusion Criteria:
- All pregnant women and nursing mothers will be exclued
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard treatment
Use of Mesna
Arm Description
Standard treatment
Standard surgical procedure with Mesna
Outcomes
Primary Outcome Measures
Compare Number of Patients With Capsular Contracture in Mesna Group vs Standard of Care
Secondary Outcome Measures
Compare Number of Patients With Adverse Events in the Mesna Group vs the Standard of Care
Full Information
NCT ID
NCT00758667
First Posted
September 23, 2008
Last Updated
December 8, 2014
Sponsor
Vanderbilt University
1. Study Identification
Unique Protocol Identification Number
NCT00758667
Brief Title
Chemically Assisted Capsulectomy-A New Clinical Approach
Official Title
Chemically Assisted Capsulectomy-A New Clinical Approach
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Terminated
Why Stopped
preliminary analysis showed no difference
Study Start Date
January 2005 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Implant Capsular Contracture
Keywords
capsular contracture, capsulectomy, mesna, Capsular contracture after breast implant placement
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard treatment
Arm Type
No Intervention
Arm Description
Standard treatment
Arm Title
Use of Mesna
Arm Type
Experimental
Arm Description
Standard surgical procedure with Mesna
Intervention Type
Drug
Intervention Name(s)
Mesna
Intervention Description
B. Mesna will be used to aid in the removal of the capsule when capsulectomy is performed
Primary Outcome Measure Information:
Title
Compare Number of Patients With Capsular Contracture in Mesna Group vs Standard of Care
Time Frame
one year
Secondary Outcome Measure Information:
Title
Compare Number of Patients With Adverse Events in the Mesna Group vs the Standard of Care
Time Frame
one year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All females undergoing capsulectomy
Exclusion Criteria:
All pregnant women and nursing mothers will be exclued
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce Shack, MD
Organizational Affiliation
Vanderbit Unviersity Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Chemically Assisted Capsulectomy-A New Clinical Approach
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