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Chemically Assisted Capsulectomy-A New Clinical Approach

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ClinicalTrials.gov Identifier: NCT00758667
Recruitment Status : Terminated (preliminary analysis showed no difference)
First Posted : September 25, 2008
Results First Posted : December 10, 2014
Last Update Posted : December 10, 2014
Sponsor:
Information provided by (Responsible Party):
R. Bruce Shack, 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.

Condition or disease Intervention/treatment Phase
Implant Capsular Contracture Drug: Mesna Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Chemically Assisted Capsulectomy-A New Clinical Approach
Study Start Date : January 2005
Actual Primary Completion Date : August 2008
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Mesna

Arm Intervention/treatment
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




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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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

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

Responsible Party: R. Bruce Shack, R. Bruce Shack, MD, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00758667     History of Changes
Other Study ID Numbers: 010518
First Posted: September 25, 2008    Key Record Dates
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