drugset / Trial / NCT00161759

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

NCT00161759

Phase 1/2 Completed 40 enrolled Baxter Healthcare Corporation
RandomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2002-03
Primary completion
Completion
2004-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Fibrinogen Concentrate Human Protein / enzyme biologic 4 iu

Indications

No indication recorded.