NCT00999141

Efficacy and Safety of FS VH S/D 4 S-apr for Flap Adherence in Rhytidectomy

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 75 (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 FS VH S/D 4 s-apr versus standard of care in adhering tissue and improving wound healing in subjects undergoing facelift.

Conditions

• Face-lift
• Facial Rhytidectomy

Interventions

Type	Name	Description
BIOLOGICAL	FS VH S/D 4 s-apr	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.

Timeline

• Start date: 2009-09-01
• Primary completion: 2009-12-01
• Completion: 2010-02-01
• First posted: 2009-10-21
• Last updated: 2012-10-08
• Results posted: 2012-08-27

Locations

6 sites across 1 country: United States