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NCT01649505 · ClinicalTrials.gov registry record · NA
Fibrin Sealant in Preventing Fluid Build Up During Surgery in Patients Undergoing Breast Reconstruction
A NA study, sponsored by OHSU Knight Cancer Institute.
- Terminated
- Registry status
- NA
- Development phase
- 2
- Enrollment target
NCT01649505: Clinical Trial NA study, sponsored by OHSU Knight Cancer Institute.
NCT01649505 is a NA study that was terminated before completion, run by OHSU Knight Cancer Institute. The registered enrollment target is 2 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01649505, a NA study, was terminated before completion, sponsored by OHSU Knight Cancer Institute.
- TERMINATED
- Registry status
- NA
- Development phase
- 2 participants
- Enrollment target
Study Summary
The purpose of this study is to investigate the efficacy of an alternative surgical technique and the use of fibrin sealant in preventing post-operative seroma formation. A seroma is a build-up of clear bodily fluids in a place on the body where tissue has been removed by surgery. Seromas can happen after breast surgeries. Seromas can appear about 7 to 10 days after surgery, after the drainage tubes have been removed. The breast area involved in the surgery may have a spot that's swollen and feels like there is liquid under the skin
Primary Outcome
Computed with 95% confidence interval using exact method. The difference of seroma rate in the two groups will be computed with 95% confidence interval using exact method. Two-sided Fisher's exact test will be used to evaluate whether the seroma rate are significantly different for the two treatment groups.
Interventions
- DRUG fibrin sealant (Beriplast P, TISSEEL VH)
- PROCEDURE breast reconstruction
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2011-01 |
| Est. Completion | 2012-01 |
| Phase | NA |
Why NCT01649505 stopped before completion
NCT01649505 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 2 interventions - of which fibrin sealant (Beriplast P, TISSEEL VH) is the first listed.
NCT01649505 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01649505 about?
NCT01649505 is a clinical study titled "Fibrin Sealant in Preventing Fluid Build Up During Surgery in Patients Undergoing Breast Reconstruction". The purpose of this study is to investigate the efficacy of an alternative surgical technique and the use of fibrin sealant in preventing post-operative seroma formation. A seroma is a build-up of clear bodily fluids in a place on the body where tissue has been removed by surgery. Seromas can happen...
What is the current status of trial NCT01649505?
This trial is currently terminated. It is a NA study. The enrollment target is 2 participants. The study started on 2011-01. Estimated completion is 2012-01.
What interventions are being tested in trial NCT01649505?
The interventions under investigation include: fibrin sealant (Beriplast P, TISSEEL VH) (DRUG), breast reconstruction (PROCEDURE).
Who is sponsoring clinical trial NCT01649505?
This trial is sponsored by OHSU Knight Cancer Institute, which has 211 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01649505's enrollment target sits among peer trials
2 1997th of 2000 the lowest of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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