This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Chemically Assisted Capsulectomy-A New Clinical Approach

This study has been terminated.
(preliminary analysis showed no difference)
Information provided by (Responsible Party):
R. Bruce Shack, Vanderbilt University Identifier:
First received: September 23, 2008
Last updated: December 8, 2014
Last verified: December 2014
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.

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

Inclusion Criteria:

  • All females undergoing capsulectomy

Exclusion Criteria:

  • All pregnant women and nursing mothers will be exclued
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00758667

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

Responsible Party: R. Bruce Shack, R. Bruce Shack, MD, Vanderbilt University Identifier: NCT00758667     History of Changes
Other Study ID Numbers: 010518
Study First Received: September 23, 2008
Results First Received: December 23, 2013
Last Updated: December 8, 2014

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

Additional relevant MeSH terms:
Implant Capsular Contracture
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases
Foreign-Body Reaction
Pathologic Processes
Prosthesis Failure
Postoperative Complications
Protective Agents
Physiological Effects of Drugs processed this record on September 18, 2017