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 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.

Study Overview

• Status: Completed
• Conditions: Infected Seroma After Surgical Procedure
• Intervention / Treatment: Device: Penrose drain placement

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.

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Lansing, Michigan, United States, 48912
      • Michigan State University Dept Surgery/Sparrow Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• diagnosis of breast cancer
• received accelerated partial breast irradiation

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Development of lumpectomy cavity seroma	The patient will be evaluated by physical exam and ultrasound of the affected breast.	1 month and 4 months

Collaborators and Investigators

• Sponsor: Michigan State University
• Investigators: Principal Investigator: Harvey Bumpers, MD, Michigan State University, CHM

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2013
• Primary Completion (ACTUAL): August 1, 2017
• Study Completion (ACTUAL): November 1, 2017

Study Registration Dates

• First Submitted: March 11, 2015
• First Submitted That Met QC Criteria: March 11, 2015
• First Posted (ESTIMATE): March 17, 2015

Study Record Updates

• Last Update Posted (ACTUAL): April 12, 2019
• Last Update Submitted That Met QC Criteria: April 10, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: breast cancer; seroma; accelerated partial breast irradiation (APBI); breast lumpectomy
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Seroma
• Other Study ID Numbers: 13-931M; i044456