Trials / Completed
CompletedNCT01112735
Efficacy and Safety of ARTISS for Flap Adherence in Abdominoplasty
A Randomized, Controlled, Multicenter Phase 2 Study to Evaluate the Efficacy and Safety of ARTISS (FS VH S/D 4 S-apr) for Flap Adherence in Subjects Undergoing Abdominoplasty
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Baxter Healthcare Corporation · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | FS VH S/D 4 s-apr (= two-component fibrin sealant, double virus inactivated, made from pooled human plasma) | Dosage form: spray (aerosolized sealant), Dosage frequency: once (1 layer). ARTISS will be applied onto the fascia or the wound bed. |
| PROCEDURE | Standard of care | Standard of care |
Timeline
- Start date
- 2010-05-01
- Primary completion
- 2010-12-01
- Completion
- 2011-02-01
- First posted
- 2010-04-28
- Last updated
- 2018-07-06
- Results posted
- 2018-07-06
Locations
6 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01112735. Inclusion in this directory is not an endorsement.