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

Phase 3 Completed 75 enrolled Baxter Healthcare Corporation

RandomizedSingle-groupSingle-blindTreatment

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.

Timeline

Start: 2009-09
Primary completion: 2009-12
Completion: 2010-02

Outcome

Met primary endpoint

registry analysis (superiority or other test); Standard of Care (SoC) vs FS VH S/D 4 S-apr; p <0.0001; two-sided paired t-test NCT00999141 ↗

Publications

Hester TR Jr, Shire JR, Nguyen DB, Gerut ZE, Chen AH, Diamond J, Desmond JC, Silvati-Fidell L, Abrams SZ, Rohrich RJ. Randomized, controlled, phase 3 study to evaluate the safety and efficacy of fibrin sealant VH S/D 4 s-apr (Artiss) to improve tissue adherence in subjects undergoing rhytidectomy. Aesthet Surg J. 2013 May;33(4):487-96. doi: 10.1177/1090820X13479969. Epub 2013 Apr 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	FS VH S/D 4 s-apr	Protein / enzyme biologic	—	Topical

Indications

No indication recorded.