NCT00157131

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

A Study To Evaluate the Safety and Efficacy of Fibrin Sealant With 4IU/mL Thrombin, Vapor Heated, Solvent Detergent Treated (FS 4IU VH S/D) to Adhere Tissues and Improve Wound Healing

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Baxter Healthcare Corporation · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Deep Partial or Full Thickness Wounds

Interventions

Type	Name	Description
BIOLOGICAL	Fibrin Sealant, ARTISS 4IU/ml VH SD	FS 4IU VH S/D, a two-component fibrin sealant with 4 IU/mL human thrombin, vapor heated, solvent detergent treated, provided in a frozen, ready-to-use formulation. Administration by a topical spray application using the TISSOMAT device and Spray Set.
OTHER	Staples	Administration by mechanical/multiple point fixation.

Timeline

• Start date: 2004-06-01
• Primary completion: 2007-02-01
• Completion: 2007-02-01
• First posted: 2005-09-12
• Last updated: 2017-04-20

Locations

17 sites across 1 country: United States