At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 40 enrolled
Drug / intervention
FS VH S/D 4 s-apr (= two-component fibrin sealant, double virus inactivated, made from pooled human plasma) +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating FS VH S/D 4 s-apr (= two-component fibrin sealant, double virus inactivated, made from pooled human plasma) and Standard of care for Seroma and Hematoma. Completed, enrolled 40 participants across 6 sites.
Detailed 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.
Study Details
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 2010
Enrollment StartMay 2010
Primary CompletionDec 2010
Study CompletionFeb 2011
TodayJul 2026
First PostedApr 28, 2010
Enrollment StartMay 1, 2010
Primary CompletionDec 1, 2010
Study CompletionFeb 1, 2011
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 16.2 years ago
Interventions
FS VH S/D 4 s-apr (= two-component fibrin sealant, double virus inactivated, made from pooled human plasma)biological
Dosage form: spray (aerosolized sealant), Dosage frequency: once (1 layer). ARTISS will be applied onto the fascia or the wound bed.
Standard of careprocedure
Standard of care