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Chemically Assisted Capsulectomy-A New Clinical Approach

This study has been terminated.
(preliminary analysis showed no difference)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00758667
First Posted: September 25, 2008
Last Update Posted: December 10, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
R. Bruce Shack, Vanderbilt University
  Purpose
The purpose of this study is to make available an agent,Mesna, which can assist the surgeon during the procedure of capsulectomy.

Condition Intervention
Implant Capsular Contracture Drug: Mesna

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Chemically Assisted Capsulectomy-A New Clinical Approach

Resource links provided by NLM:


Further study details as provided by R. Bruce Shack, Vanderbilt University:

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

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

Enrollment: 20
Study Start Date: January 2005
Study Completion Date: December 2009
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard treatment
Standard treatment
Experimental: Use of Mesna
Standard surgical procedure with Mesna
Drug: Mesna
B. Mesna will be used to aid in the removal of the capsule when capsulectomy is performed

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All females undergoing capsulectomy

Exclusion Criteria:

  • All pregnant women and nursing mothers will be exclued
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00758667


Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Bruce Shack, MD Vanderbit Unviersity Medical Center
  More Information

Responsible Party: R. Bruce Shack, R. Bruce Shack, MD, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00758667     History of Changes
Other Study ID Numbers: 010518
First Submitted: September 23, 2008
First Posted: September 25, 2008
Results First Submitted: December 23, 2013
Results First Posted: December 10, 2014
Last Update Posted: December 10, 2014
Last Verified: December 2014

Keywords provided by R. Bruce Shack, Vanderbilt University:
capsular contracture
capsulectomy
mesna
Capsular contracture after breast implant placement

Additional relevant MeSH terms:
Contracture
Implant Capsular Contracture
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases
Foreign-Body Reaction
Inflammation
Pathologic Processes
Prosthesis Failure
Postoperative Complications
Mesna
Protective Agents
Physiological Effects of Drugs