At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 75 enrolled
Drug / intervention
FS VH S/D 4 s-aprbiological
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 Phase 3 Study to Evaluate Safety and Efficacy of Fibrin Sealant (FS) VH S/D 4 S-apr (ARTISS) to Adhere Tissues and Improve Wound Healing in Subjects Undergoing Rhytidectomy (Facelift)
In Brief
A Phase 3 clinical trial evaluating FS VH S/D 4 s-apr for Face-lift and Facial Rhytidectomy. Completed, enrolled 75 participants across 6 sites.
Detailed Summary
The purpose of the study is to compare the safety and efficacy of FS VH S/D 4 s-apr versus standard of care in adhering tissue and improving wound healing in subjects undergoing facelift.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFace-lift, Facial Rhytidectomy
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2009
First PostedOct 2009
Primary CompletionDec 2009
Study CompletionFeb 2010
TodayJul 2026
First PostedOct 21, 2009
Enrollment StartSep 1, 2009
Primary CompletionDec 1, 2009
Study CompletionFeb 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 16.7 years ago
Interventions
FS VH S/D 4 s-aprbiological
FS VH S/D 4 s-apr will be applied (using spray device provided by Sponsor) to the subcutaneous plane (intraoperative, topical administration) in both the neck and the face area.