MedTrace Logo

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

NCT00161759 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2006-10-20

No results posted yet for this study

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

DRUG

Sheet skin grafts affixed with Fibrin Sealant (lyophilized) with 4 IU/mL Thrombin

Sponsors & Collaborators

  • Baxter Healthcare Corporation

    lead INDUSTRY

Principal Investigators

  • David G. Greenhalgh, MD · University of California Davis Medical Center, Sacramento; Shriners Hospitals for Children, Sacramento, CA

  • Marianne Cinat, MD · University of California Irvine, Orange, CA

  • Arnold Luterman, MD · University of South Alabama Medical Center, Mobile, AL

  • Nicole Gibran, MD · University of Washington Burn Center, Seattle, WA

  • Glenn D. Warden, MD · Shriners Hospitals for Children, Cincinnati, OH

  • David Herndon, MD · Shriners Hospitals for Children, Galveston, TX

  • Richard L. Gamelli, MD · Loyola University Medical Center, Maywood, IL

  • Sidney F. Miller, MD · Wright State University, Miami Valley Hospital, Dayton, OH

  • Daniel Lozano, MD · University of California, San Diego

  • Philip E. Fidler, MD · Bridgeport Hospital, Bridgeport, CT

  • Kevin Foster, MD · Maricopa Medical Center, Phoenix, AZ

  • William L. Hickerson, MD · Joseph M. Still Burn Center at Doctors Hospital, August, GA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-03-31
Completion
2004-01-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00161759 on ClinicalTrials.gov