Drain Placement for Seroma Prevention After Mammosite/SAVI Catheter Removal

Completed · Not applicable

Conditions studied: Infected Seroma After Surgical Procedure

In brief

The proposed study is randomised controlled trial where informed and consenting patients who have a Mammosite/SAVI device placed, are randomized into two groups: a control group that has the device removed in the traditional manner without having a drain placed, and an experimental group that will have a penrose drain placed under sterile conditions at the time of removal of their device. The drain will be placed in the same site used for the APBI device and no additional surgery will be performed. The drain will remain for 2-3 days and it will be removed by the patient at home. They will return for their routine follow-up appointments and be monitored for development of a seroma with the use of standard ultrasound and physical exam. Hypothesis: Based on the null hypothesis there will be no difference in the rate of seroma formation after the APBI device removal if a drain is placed.

Key facts

Study ID

NCT02390661

Run by

Michigan State University

People needed

37

Starts

2013-11-01

Expected to finish

2017-11-01

Last updated by the study team

2019-04-12

Who can join

Age: 45 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• diagnosis of breast cancer
• received accelerated partial breast irradiation

You may not qualify if…

• any metastatic breast cancer
• infection
• skin with radiation injury

Where it is running

• Michigan State University Dept Surgery/Sparrow Hospital — Lansing, Michigan, United States

Full record on ClinicalTrials.gov

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