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Chemically Assisted Capsulectomy-A New Clinical Approach

This study has been withdrawn prior to enrollment.
(preliminary analysis showed no difference)
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00758667
First received: September 23, 2008
Last updated: October 25, 2011
Last verified: October 2011
History of Changes
  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
Capsular Contracture
 Drug: Mesna

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

Resource links provided by NLM:

Drug Information available for: Mesna
U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Evaluate the safety and efficacy of Mesna as an agent for chemically assisted capsulectomies [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare capsular contracture rates between the control and the Mesna group one year after surgery [ Time Frame: one year ] [ Designated as safety issue: No ]

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
B
Standard procedure for removal of capsule; no mesna
 Drug: Mesna
A. Mesna will be used to aid in the removal of the capsule when capsulectomy is performed
Experimental: A.
The use of Mesna of removal of capsule for capsular contracture.
 Drug: Mesna
A. 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
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, MD, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00758667     History of Changes
Other Study ID Numbers: 010518
Study First Received: September 23, 2008
Last Updated: October 25, 2011
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
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases
 Mesna
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013