Drain Placement for Seroma Prevention After Mammosite/SAVI Catheter Removal

NCT ID: NCT02390661

Last Updated: 2019-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2017-11-30

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.

Conditions

Infected Seroma After Surgical Procedure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

No drain

Control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Penrose drain placement

Placement of a penrose drain after irradiation catheter is removed

Group Type: EXPERIMENTAL

Penrose drain placement

Intervention Type: DEVICE

A penrose drain will be placed in the lumpectomy cavity after removal of the irradiation catheter

Interventions

Penrose drain placement

A penrose drain will be placed in the lumpectomy cavity after removal of the irradiation catheter

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• diagnosis of breast cancer
• received accelerated partial breast irradiation

Exclusion Criteria

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

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Michigan State University

OTHER

Sponsor Role: lead

Responsible Party

Harvey Bumpers

Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Harvey Bumpers, MD

Role: PRINCIPAL_INVESTIGATOR

Michigan State University, CHM

Locations

Michigan State University Dept Surgery/Sparrow Hospital

Lansing, Michigan, United States

Countries

United States

Other Identifiers

13-931M; i044456

Identifier Type: -

Identifier Source: org_study_id