Chemically Assisted Capsulectomy-A New Clinical Approach

Vanderbilt University

Status: Terminated

Conditions: Implant Capsular Contracture

Treatments: Drug: Mesna

Study type: Interventional

Funder types: Other

Identifiers

NCT00758667

010518

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All females undergoing capsulectomy

Exclusion criteria

• All pregnant women and nursing mothers will be exclued

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

Standard treatment

No Intervention group

Description:

Standard treatment

Use of Mesna

Experimental group

Description:

Standard surgical procedure with Mesna

Treatment:

Drug: Mesna