Infected Seroma After Surgical ProcedureNCT02390661
Drain Placement for Seroma Prevention After Mammosite/SAVI Catheter Removal
A study testing Penrose drain placement in people with Infected Seroma After Surgical Procedure, run by Michigan State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Infected Seroma After Surgical Procedure
- What is being tested?
- Penrose drain placement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of breast cancer
- received accelerated partial breast irradiation
Who cannot join
- any metastatic breast cancer
- infection
- skin with radiation injury
Trial locations and contacts
1 site in 1 country.
United States1 site
Michigan State University Dept Surgery/Sparrow Hospital
Lansing, Michigan, 48912
About this study
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.
Read the 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
- Being tested
- Penrose drain placement
- Keywords
- seroma, accelerated partial breast irradiation (APBI), breast lumpectomy, breast cancer
- Medical subject headings
- Seroma, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Penrose drain placementDevice
A penrose drain will be placed in the lumpectomy cavity after removal of the irradiation catheter
| Study group | Role | What they receive |
|---|---|---|
| No drain | No intervention | Control group |
| Penrose drain placement | Experimental | Placement of a penrose drain after irradiation catheter is removed Receives: Device: Penrose drain placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of lumpectomy cavity seroma
The patient will be evaluated by physical exam and ultrasound of the affected breast.
Measured: 1 month and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startNov 2013
- Primary completionAug 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infected Seroma After Surgical ProcedureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Harvey Bumpers, Michigan State University
- Investigators
- Harvey Bumpers, MD, Principal investigator, Michigan State University, CHM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02390661
- Sponsor's protocol ID
- 13-931M; i044456
- Status last verified
- Apr 2019
- First submitted
- 11 Mar 2015
- Last updated
- 12 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drain Placement for Seroma Prevention After Mammosite/SAVI Catheter Removal
- ClinicalTrials.gov ID
- NCT02390661
- Acronym / sponsor ID
- 13-931M; i044456
- Conditions
- Infected Seroma After Surgical Procedure
- Keywords
- seroma, accelerated partial breast irradiation (APBI), breast lumpectomy, breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Study start
- Nov 2013 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 17 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No drain | No intervention | –Control group |
| Penrose drain placement | Experimental | Device: Penrose drain placementPlacement of a penrose drain after irradiation catheter is removed |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- diagnosis of breast cancer
- received accelerated partial breast irradiation
Key exclusion criteria (3 listed)
- any metastatic breast cancer
- infection
- skin with radiation injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Penrose drain placementA penrose drain will be placed in the lumpectomy cavity after removal of the irradiation catheter | Device | Penrose drain placement |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harvey Bumpers, MD principal investigator
Michigan State University, CHM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Penrose drain placement in people with Infected Seroma After Surgical Procedure, run by Michigan State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of lumpectomy cavity seroma (time frame: 1 month and 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2019.