NCT00157131View on ClinicalTrials.gov

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

PHASE3CompletedINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

June 30, 2004

Primary Completion Date

February 28, 2007

Study Completion Date

February 28, 2007

Conditions
Deep Partial or Full Thickness Wounds
Interventions
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.

Trial Locations (17)

Unknown

Phoenix

Orange

Sacramento

San Diego

Gainesville

Maywood

Springfield

Baltimore

Lincoln

Cincinnati

Allentown

Philadelphia

Lubbock

Seattle

Madison

Birmingham

Mobile

All Listed Sponsors
lead

Baxter Healthcare Corporation

INDUSTRY

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 | Biotech Hunter | Biotech Hunter