Drain Placement for Seroma Prevention After Mammosite/SAVI Catheter Removal
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 45 - Any |
| Updated: | 4/21/2016 |
| Start Date: | November 2013 |
| End Date: | November 2016 |
| Contact: | Pam Haan, RN, BSN |
| Email: | pam.haan@ht.msu.edu |
| Phone: | (517) 267-2460 |
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.
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.
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.
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.
Inclusion Criteria:
- diagnosis of breast cancer
- received accelerated partial breast irradiation
Exclusion Criteria:
- any metastatic breast cancer
- infection
- skin with radiation injury
We found this trial at
1
site
Lansing, Michigan 48912
Principal Investigator: Harvey Bumpers, MD
Phone: 517-267-2460
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