Efficacy and Safety Study of Fibrin Sealant With 4 IU/mL Thrombin, Vapor Heated, Solvent Detergent Treated (FS VH S/D 4) in Face-Lift Procedures

Phase 2 Completed 45 enrolled Baxter Healthcare Corporation

RandomizedSingle-groupSingle-blindTreatment

Summary

The primary objective of this study is to evaluate the efficacy and safety of fibrin sealant with 4 IU/mL thrombin, vapor heated, solvent detergent treated (FS VH S/D 4) when used to reduce early postoperative bruising in participants undergoing a rhytidectomy (face-lift).

Timeline

Start: 2008-06
Primary completion: 2008-09
Completion: 2008-09

Outcome

Missed primary endpoint

registry Participants With Less Ecchymosis Treated With FS VH S/D 4 vs Participants With Less Ecchymosis Treated With SoC; p = 0.143 NCT00708071 ↗

Publications

Hester TR Jr, Gerut ZE, Shire JR, Nguyen DB, Chen AH, Diamond J, Desmond JC, Silvati-Fidell L, Abrams SZ. Exploratory, randomized, controlled, phase 2 study to evaluate the safety and efficacy of adjuvant fibrin sealant VH S/D 4 S-Apr (ARTISS) in patients undergoing rhytidectomy. Aesthet Surg J. 2013 Mar;33(3):323-33. doi: 10.1177/1090820X13477860.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ARTISS	Protein / enzyme biologic	—	Subcutaneous

Indications

No indication recorded.