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NCT01112735 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of ARTISS for Flap Adherence in Abdominoplasty
A Phase 2 study, sponsored by Baxter Healthcare Corporation.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
NCT01112735: Completed Phase 2 study, sponsored by Baxter Healthcare Corporation.
NCT01112735 is a Phase 2 study that has completed, run by Baxter Healthcare Corporation. The registered enrollment target is 40 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01112735, a Phase 2 study, has completed, sponsored by Baxter Healthcare Corporation.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
Study Summary
The purpose of the study is to compare the safety and efficacy of ARTISS versus standard of care in adhering tissue places and reducing seroma/hematoma formation in subjects undergoing abdominoplasty.
Primary Outcome
Drainage fluids were to be collected through the Blake drain and into the collection bulb. The drainage volume was measured and recorded daily until the removal of the drain. During scheduled visits, measurement was to be performed at the study site, and on non-visit day recording of the drainage volume was to be done by a visiting home care nurse (or other study personnel). The drain was ready to be removed when the drainage volume in a given 24 hour period was \<=30 cc.
Interventions
- PROCEDURE Standard of care
- BIOLOGICAL FS VH S/D 4 s-apr (= two-component fibrin sealant, double virus inactivated, made from pooled human plasma)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2010-05 |
| Est. Completion | 2011-02 |
| Phase | Phase 2 |
What the finished NCT01112735 record still lists
NCT01112735 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 2 interventions - of which Standard of care is the first listed.
NCT01112735 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01112735 about?
NCT01112735 is a clinical study titled "Efficacy and Safety of ARTISS for Flap Adherence in Abdominoplasty". The purpose of the study is to compare the safety and efficacy of ARTISS versus standard of care in adhering tissue places and reducing seroma/hematoma formation in subjects undergoing abdominoplasty.
What is the current status of trial NCT01112735?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2010-05. Estimated completion is 2011-02.
What interventions are being tested in trial NCT01112735?
The interventions under investigation include: Standard of care (PROCEDURE), FS VH S/D 4 s-apr (= two-component fibrin sealant, double virus inactivated, made from pooled human plasma) (BIOLOGICAL).
Who is sponsoring clinical trial NCT01112735?
This trial is sponsored by Baxter Healthcare Corporation, which has 46 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01112735's enrollment target sits among peer trials
40 1362nd of 2000 higher than 542 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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