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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sheet skin grafts affixed with Fibrin Sealant (lyophilized) with 4 IU/mL Thrombin | Drug |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David G. Greenhalgh, MD | University of California Davis Medical Center, Sacramento; Shriners Hospitals for Children, Sacramento, CA | Principal Investigator |
| Marianne Cinat, MD | University of California Irvine, Orange, CA | Principal Investigator |
| Arnold Luterman, MD | University of South Alabama Medical Center, Mobile, AL | Principal Investigator |
| Nicole Gibran, MD | University of Washington Burn Center, Seattle, WA | Principal Investigator |
| Glenn D. Warden, MD | Shriners Hospitals for Children, Cincinnati, OH | Principal Investigator |
| David Herndon, MD | Shriners Hospitals for Children, Galveston, TX | 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 |
| Daniel Lozano, MD | University of California, San Diego |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Alabama Medical Center | Mobile | Alabama | 36617 | United States | ||
| Maricopa Medical Center |
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| Principal Investigator |
| Philip E. Fidler, MD | Bridgeport Hospital, Bridgeport, CT | Principal Investigator |
| Kevin Foster, MD | Maricopa Medical Center, Phoenix, AZ | Principal Investigator |
| William L. Hickerson, MD | Joseph M. Still Burn Center at Doctors Hospital, August, GA | Principal Investigator |
| Phoenix |
| Arizona |
| 85008 |
| United States |
| UCI Medical Center | Orange | California | 92868-3298 | United States |
| University of California Davis Medical Center; Shriners Hospitals for Children | Sacramento | California | 95817 | United States |
| UCSD Medical Center | San Diego | California | 92103-8896 | United States |
| Bridgeport Hospital | Bridgeport | Connecticut | 06610 | United States |
| Joseph M. Still Burn Center at Doctors Hospital | Augusta | Georgia | 30909 | United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| Shriners Hospitals for Children | Cincinnati | Ohio | 45229 | United States |
| Wright State University, Miami Valley Hospital | Dayton | Ohio | 45409-2722 | United States |
| Shriners Hospitals for Children, Galveston | Galveston | Texas | 77550-2725 | United States |
| University of Washington Burn Center | Seattle | Washington | 98104 | United States |
| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D015718 | Fibrin Tissue Adhesive |
| D013917 | Thrombin |
| ID | Term |
|---|---|
| D005337 | Fibrin |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D001779 | Blood Coagulation Factors |
| D001685 | Biological Factors |
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