Drain Placement for Seroma Prevention After Mammosite/SAVI Catheter Removal
Primary Purpose
Infected Seroma After Surgical Procedure
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Penrose drain placement
Sponsored by
About this trial
This is an interventional prevention trial for Infected Seroma After Surgical Procedure focused on measuring seroma, accelerated partial breast irradiation (APBI), breast lumpectomy, breast cancer
Eligibility Criteria
Inclusion Criteria:
- diagnosis of breast cancer
- received accelerated partial breast irradiation
Exclusion Criteria:
- any metastatic breast cancer
- infection
- skin with radiation injury
Sites / Locations
- Michigan State University Dept Surgery/Sparrow Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
No drain
Penrose drain placement
Arm Description
Control group
Placement of a penrose drain after irradiation catheter is removed
Outcomes
Primary Outcome Measures
Development of lumpectomy cavity seroma
The patient will be evaluated by physical exam and ultrasound of the affected breast.
Secondary Outcome Measures
Full Information
NCT ID
NCT02390661
First Posted
March 11, 2015
Last Updated
April 10, 2019
Sponsor
Michigan State University
1. Study Identification
Unique Protocol Identification Number
NCT02390661
Brief Title
Drain Placement for Seroma Prevention After Mammosite/SAVI Catheter Removal
Official Title
Drain Placement for Seroma Prevention After Mammosite/SAVI Catheter Removal
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
November 2013 (Actual)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
November 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Michigan State University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed Description
The proposed study is randomised controlled trial where informed and consenting patients who have an APBI 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 a experimental group that would have a penrose drain placed under sterile conditions at the time of removal of their device. The procedure will be performed at the MSU Surgery outpatient clinic by residents, the senior investigator or a trained nurse/PA. Additional data will be collected on each patient from their medical record including demographic data, cancer diagnosis, lesion size, date of procedure, date Mammosite/SAVI was inserted and removed, total dose of radiation, ER, PR, HER2Neu status, and any chemotherapy or hormone therapy being administered. Drains will remain in place for 2-3 days and will be removed by the patient upon removing the dressing. Patients will continue their antibiotic regimen prescribed while the APBI device was in place for the 2-3 days the drain is in place for infection prophylaxis. Patients will be followed for 4 weeks to determine if a seroma or other complication has developed. Patients in both the experimental and control groups will have the same standard follow up and monitoring for seroma development with the use of ultrasound. All postop cancer care will be standard and this study will not alter or delay any aspect of breast cancer treatment. Statistics will be performed and reported based upon data collected.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infected Seroma After Surgical Procedure
Keywords
seroma, accelerated partial breast irradiation (APBI), breast lumpectomy, breast cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No drain
Arm Type
No Intervention
Arm Description
Control group
Arm Title
Penrose drain placement
Arm Type
Experimental
Arm Description
Placement of a penrose drain after irradiation catheter is removed
Intervention Type
Device
Intervention Name(s)
Penrose drain placement
Intervention Description
A penrose drain will be placed in the lumpectomy cavity after removal of the irradiation catheter
Primary Outcome Measure Information:
Title
Development of lumpectomy cavity seroma
Description
The patient will be evaluated by physical exam and ultrasound of the affected breast.
Time Frame
1 month and 4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diagnosis of breast cancer
received accelerated partial breast irradiation
Exclusion Criteria:
any metastatic breast cancer
infection
skin with radiation injury
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harvey Bumpers, MD
Organizational Affiliation
Michigan State University, CHM
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michigan State University Dept Surgery/Sparrow Hospital
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Drain Placement for Seroma Prevention After Mammosite/SAVI Catheter Removal
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