NCT00161759

Safety and Efficacy Study of Fibrin Sealant (FS 4IU) for Skin Graft Fixation and Wound Healing in Subjects With Burn Wounds

A Study to Assess the Safety and Efficacy of Fibrin Sealant (FS 4IU) for Wound Healing in Subjects With Burn Wounds Requiring Skin Grafting Procedures

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (planned)
• Sponsor: Baxter Healthcare Corporation · Industry
• Sex: All
• Age: 6 Years – 65 Years
• Healthy volunteers: —

Summary

The purpose of this study is to assess if Fibrin Sealant 4IU is as safe and efficacious as staples (the current standard of care) to achieve fixation of skin grafts and wound healing in subjects with burn wounds. Each subject receives staples as well as FS 4IU on comparable treatment sites.

Conditions

• Burns

Interventions

Type	Name	Description
DRUG	Sheet skin grafts affixed with Fibrin Sealant (lyophilized) with 4 IU/mL Thrombin

Timeline

• Start date: 2002-03-01
• Completion: 2004-01-01
• First posted: 2005-09-13
• Last updated: 2006-10-20

Locations

12 sites across 1 country: United States