Chemically Assisted Capsulectomy-A New Clinical Approach

This study has been terminated.
(preliminary analysis showed no difference)
Sponsor:
Information provided by (Responsible Party):
R. Bruce Shack, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00758667
First received: September 23, 2008
Last updated: December 8, 2014
Last verified: December 2014
  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 Blind (Subject, 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 Vanderbilt University:

Primary Outcome Measures:
  • Compare Number of Patients With Capsular Contracture in Mesna Group vs Standard of Care [ Time Frame: one year ] [ Designated as safety issue: No ]

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

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

Ages Eligible for Study:   18 Years to 65 Years
Genders 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
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 ClinicalTrials.gov identifier: NCT00758667

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

No publications provided

Responsible Party: R. Bruce Shack, R. Bruce Shack, MD, Vanderbilt University
ClinicalTrials.gov 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
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
capsular contracture
capsulectomy
mesna
Capsular contracture after breast implant placement

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

ClinicalTrials.gov processed this record on June 28, 2015