Safety and Efficacy Study of FS 4 IU VH S/D (Fibrin Sealant With 4IU/mL Thrombin, Vapor Heated, Solvent/Detergent Treated) to Adhere Split Thickness Skin Grafts and Improve Wound Healing in Burn Patients

Phase 3 Completed 150 enrolled Baxter Healthcare Corporation

RandomizedParallel-groupSingle-blindTreatment

Summary

The primary objective of this study is to evaluate skin graft adherence and wound healing in burn patients to evaluate whether FS 4IU VH S/D is equivalent or superior to the current standard of care (staples). The primary endpoint is achievement of complete (100%) wound closure within 28 days.

Timeline

Start: 2004-06
Primary completion: 2007-02
Completion: 2007-02

Outcome

Met primary endpoint

paper The lower limit of the 97.5% confidence interval of the difference between FS 4IU VH S/D and staples was -0.029, which is above the predefined noninferiority margin of -0.1. PMID 18354285 ↗

Publications

Results Foster K, Greenhalgh D, Gamelli RL, Mozingo D, Gibran N, Neumeister M, Abrams SZ, Hantak E, Grubbs L, Ploder B, Schofield N, Riina LH; FS 4IU VH S/D Clinical Study Group. Efficacy and safety of a fibrin sealant for adherence of autologous skin grafts to burn wounds: results of a phase 3 clinical study. J Burn Care Res. 2008 Mar-Apr;29(2):293-303. doi: 10.1097/BCR.0b013e31816673f8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ARTISS	Protein / enzyme biologic	2 ml	Topical
Subject	ARTISS	Protein / enzyme biologic	4 ml	Topical

Indications

No indication recorded.