Clinical trial · Interventional
Drain Placement for Seroma Prevention After Mammosite/SAVI Catheter Removal
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Infected Seroma After Surgical Procedure | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Penrose drain placement | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- No drain
- description
- Control group
- type
- EXPERIMENTAL
- label
- Penrose drain placement
- description
- Placement of a penrose drain after irradiation catheter is removed
- interventionNames
- Device: Penrose drain placement
Primary outcomes (1)
- measure
- Development of lumpectomy cavity seroma
- timeFrame
- 1 month and 4 months
- description
- The patient will be evaluated by physical exam and ultrasound of the affected breast.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * diagnosis of breast cancer * received accelerated partial breast irradiation Exclusion Criteria: * any metastatic breast cancer * infection * skin with radiation injury
References
Publications (0)
Data not yet available