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Chemically Assisted Capsulectomy-A New Clinical Approach

NCT ID: NCT00758667

Last Updated: 2014-12-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2009-12-31

Brief Summary

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The purpose of this study is to make available an agent,Mesna, which can assist the surgeon during the procedure of capsulectomy.

Detailed Description

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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.

Conditions

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Implant Capsular Contracture

Keywords

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capsular contracture capsulectomy mesna Capsular contracture after breast implant placement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Standard treatment

Standard treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Use of Mesna

Standard surgical procedure with Mesna

Group Type EXPERIMENTAL

Mesna

Intervention Type DRUG

B. Mesna will be used to aid in the removal of the capsule when capsulectomy is performed

Interventions

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Mesna

B. Mesna will be used to aid in the removal of the capsule when capsulectomy is performed

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* All females undergoing capsulectomy

Exclusion Criteria

* All pregnant women and nursing mothers will be exclued
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Vanderbilt University

OTHER

Sponsor Role lead

Responsible Party

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R. Bruce Shack

R. Bruce Shack, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bruce Shack, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbit Unviersity Medical Center

Countries

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United States

Other Identifiers

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010518

Identifier Type: -

Identifier Source: org_study_id