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Drain Placement for Seroma Prevention After Mammosite/SAVI Catheter Removal

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ClinicalTrials.gov Identifier: NCT02390661
Recruitment Status : Completed
First Posted : March 17, 2015
Last Update Posted : April 12, 2019
Sponsor:
Information provided by (Responsible Party):
Harvey Bumpers, Michigan State University

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.

Condition or disease Intervention/treatment Phase
Infected Seroma After Surgical Procedure Device: Penrose drain placement Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Drain Placement for Seroma Prevention After Mammosite/SAVI Catheter Removal
Actual Study Start Date : November 2013
Actual Primary Completion Date : August 2017
Actual Study Completion Date : November 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: No drain
Control group
Experimental: Penrose drain placement
Placement of a penrose drain after irradiation catheter is removed
Device: Penrose drain placement
A penrose drain will be placed in the lumpectomy cavity after removal of the irradiation catheter




Primary Outcome Measures :
  1. Development of lumpectomy cavity seroma [ Time Frame: 1 month and 4 months ]
    The patient will be evaluated by physical exam and ultrasound of the affected breast.



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of breast cancer
  • received accelerated partial breast irradiation

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02390661


Locations
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United States, Michigan
Michigan State University Dept Surgery/Sparrow Hospital
Lansing, Michigan, United States, 48912
Sponsors and Collaborators
Michigan State University
Investigators
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Principal Investigator: Harvey Bumpers, MD Michigan State University, CHM
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Responsible Party: Harvey Bumpers, Professor of Surgery, Michigan State University
ClinicalTrials.gov Identifier: NCT02390661    
Other Study ID Numbers: 13-931M; i044456
First Posted: March 17, 2015    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: April 2019
Keywords provided by Harvey Bumpers, Michigan State University:
seroma
accelerated partial breast irradiation (APBI)
breast lumpectomy
breast cancer
Additional relevant MeSH terms:
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Seroma
Inflammation
Pathologic Processes