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This study has been withdrawn prior to enrollment.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
  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:


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 April 17, 2014