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Clinical trialNCT00161759CompletedPhase 1/PHASE2Interventional

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

SponsorBaxter Healthcare CorporationEnrollment40Burns
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

  • Arnold Luterman, MD

    University of South Alabama Medical Center, Mobile, AL

    Principal Investigator
  • Daniel Lozano, MD

    University of California, San Diego

    Principal Investigator
  • David G. Greenhalgh, MD

    University of California Davis Medical Center, Sacramento; Shriners Hospitals for Children, Sacramento, CA

    Principal Investigator
  • David Herndon, MD

    Shriners Hospitals for Children, Galveston, TX

    Principal Investigator
  • Glenn D. Warden, MD

    Shriners Hospitals for Children, Cincinnati, OH

    Principal Investigator
  • Kevin Foster, MD

    Maricopa Medical Center, Phoenix, AZ

    Principal Investigator
  • Marianne Cinat, MD

    University of California Irvine, Orange, CA

    Principal Investigator
  • Nicole Gibran, MD

    University of Washington Burn Center, Seattle, WA

    Principal Investigator
  • Philip E. Fidler, MD

    Bridgeport Hospital, Bridgeport, CT

    Principal Investigator
  • Richard L. Gamelli, MD

    Loyola University Medical Center, Maywood, IL

    Principal Investigator
  • Sidney F. Miller, MD

    Wright State University, Miami Valley Hospital, Dayton, OH

    Principal Investigator
  • William L. Hickerson, MD

    Joseph M. Still Burn Center at Doctors Hospital, August, GA

    Principal Investigator

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

12 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • University of South Alabama Medical Center

    Mobile, Alabama, United States

  • Maricopa Medical Center

    Phoenix, Arizona, United States

  • Uci Medical Center

    Orange, California, United States

  • University of California Davis Medical Center; Shriners Hospitals for Children

    Sacramento, California, United States

  • Ucsd Medical Center

    San Diego, California, United States

  • Bridgeport Hospital

    Bridgeport, Connecticut, United States

  • Joseph M. Still Burn Center at Doctors Hospital

    Augusta, Georgia, United States

  • Loyola University Medical Center

    Maywood, Illinois, United States

  • Shriners Hospitals for Children

    Cincinnati, Ohio, United States

  • Wright State University, Miami Valley Hospital

    Dayton, Ohio, United States

  • Shriners Hospitals for Children, Galveston

    Galveston, Texas, United States

  • University of Washington Burn Center

    Seattle, Washington, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Sheet skin grafts affixed with Fibrin Sealant with 4 IU/mL Thrombin
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
31 Mar 2002
Primary completion
—
Completion
31 Jan 2004
Last update posted
20 Oct 2006
Registered enrollment
40
Registry id
NCT00161759

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.