An interventional study of Penrose drain placement in Infected Seroma After Surgical Procedure, sponsored by Michigan State University. Completed at 1 site in United States. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2019-04-12.
Sponsored by Michigan State University · Not applicable, Interventional, and Prevention
Among 19 studies in Seroma with a site in United States — 4 open to participants now, 4 under way, none of them phase 3. Seroma · United States.
Among the 19 studies in Seroma with a site in United States, this one is the 13th largest by enrollment of the 18 interventional ones, is the only one that started in 2013, is one of 14 with no phase, and was the 9th registered.
101 studies on the registry are indexed under Seroma; 22 are open to participants now.
This study's enrollment of 37 is below the median of 100 across 92 interventional studies indexed under Seroma.
Browse Seroma studies →4 of the 19 studies in Seroma with a site in United States are open now, in 1 country. Each count lists the studies.
Of the 16 Seroma studies recruiting now, 13 (81%) set no upper age limit and 3 (19%) stop at 75 or younger; 0 take children under 18; 4 take healthy volunteers.
This study: 45 Years and older · all sexes · no healthy volunteers.
The full table on the hub →19 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 1 started in 2013.
Median enrollment 52 across the 18 interventional studies, 54 across the 1 observational. Of the 11 that completed or were terminated, 6 (55%) have results posted.
4 of 19 have an industry lead sponsor. The 10 most frequent:
Michigan State University is the lead sponsor of 143 studies on the registry; 27 are open to participants now.
Michigan State University has 1 study filed under Seroma — fewer than ten, so there is no comparison to draw.
2 of the studies in Seroma with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07498010University of MiamiDoxycycline Use in Post-Operative Seromas | 2027-05-10 |
| NCT07686913Riverside University Health System Medical CenterSteri-Strip Application Versus Standard Wound Closure for Cesarean Section Incisions | 2027-06 |
Among the 19 studies in Seroma with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Control group
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
Development of lumpectomy cavity seroma
The patient will be evaluated by physical exam and ultrasound of the affected breast.
Time frame: 1 month and 4 months
Ran from Nov 2013 to primary completion in Aug 2017, 45 months.
Of 43 non-industry interventional studies with no phase under Seroma, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 65. This study's 45 months is above that.
Counting every sponsor, half of 44 studies reached it within 34 months; a quarter within 17 and three quarters within 65.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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