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NCT02390661 · ClinicalTrials.gov registry record · NA
Drain Placement for Seroma Prevention After Mammosite/SAVI Catheter Removal
A NA study, sponsored by Michigan State University.
- Completed
- Registry status
- NA
- Development phase
- 37
- Enrollment target
NCT02390661 is a NA study that has completed, run by Michigan State University. The registered enrollment target is 37 participants.
The verdict
NCT02390661, a NA study, has completed, sponsored by Michigan State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 37 participants
- Enrollment target
Study Summary
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.
Interventions
- DEVICE Penrose drain placement
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2013-11 |
| Est. Completion | 2017-11 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02390661
The ClinicalTrials.gov registry entry for NCT02390661 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Michigan State University, which has 120 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Penrose drain placement is the first listed.
NCT02390661 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02390661 about?
NCT02390661 is a clinical study titled "Drain Placement for Seroma Prevention After Mammosite/SAVI Catheter Removal". 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 h...
What is the current status of trial NCT02390661?
This trial is currently completed. It is a NA study. The enrollment target is 37 participants. The study started on 2013-11. Estimated completion is 2017-11.
What interventions are being tested in trial NCT02390661?
The interventions under investigation include: Penrose drain placement (DEVICE).
Who is sponsoring clinical trial NCT02390661?
This trial is sponsored by Michigan State University, which has 120 total clinical trials registered on ClinicalTrials.gov.
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