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

Primary Purpose

Burns

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Sheet skin grafts affixed with Fibrin Sealant (lyophilized) with 4 IU/mL Thrombin
Sponsored by
Baxter Healthcare Corporation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burns

Eligibility Criteria

6 Years - 65 Years (Child, Adult, Older Adult)All Sexes

Inclusion Criteria: Written informed consent obtained from either the subject or the subject's legally acceptable representative prior to screening activities Male or female age >= 6 and <= 65 years of age Total burn wounds measuring <= 40% TBSA to include a deep partial thickness/full thickness area requiring autologous split thickness sheet skin grafts The selected test area consisting of a contiguous, deep partial thickness/full thickness burn wound between 2% and 8% TBSA, which can be divided into two approximate halves or two bilateral wounds (each measuring between 1% and 4% TBSA) Females of child-bearing potential with a negative urine or serum pregnancy test on admission Able and willing to comply with the procedures required by the protocol Exclusion Criteria: Conductive electrical burns and chemical burns Digits, head, genitalia, palms of hands, soles of feet, and face are excluded as test sites Circumferential burns are excluded as a test area 4th or 5th degree burns Test area with infection as determined clinically by the Investigator prior to surgery Venous or arterial vascular disorder directly affecting a designated test area Known immune deficiency disorder, either congenital or acquired Chronically malnourished as determined clinically by the investigator prior to surgery (Investigators are responsible for determining subjects are chronically malnourished during the screening process. Investigators should take into consideration the following parameters: Medical history and physical appearance, the subject's body mass index, and any significant laboratory findings) Severe respiratory problems or concurrent head trauma at hospital admission Any chronic condition requiring the use of systemic corticosteroids 30 days prior to study entry and anytime during the course of the study Known or newly diagnosed diabetics requiring insulin Any other acute or chronic concurrent medical condition(s) that in the Investigator's opinion are a contraindication to skin grafting and study participation Known or suspected hypersensitivity to bovine protein Concurrent participation in another clinical trial in which an investigational agent is used. (Subjects must not have been enrolled in another clinical trial within 30 days of enrolling in this trial).

Sites / Locations

  • University of South Alabama Medical Center
  • Maricopa Medical Center
  • UCI Medical Center
  • University of California Davis Medical Center; Shriners Hospitals for Children
  • UCSD Medical Center
  • Bridgeport Hospital
  • Joseph M. Still Burn Center at Doctors Hospital
  • Loyola University Medical Center
  • Shriners Hospitals for Children
  • Wright State University, Miami Valley Hospital
  • Shriners Hospitals for Children, Galveston
  • University of Washington Burn Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 8, 2005
Last Updated
October 19, 2006
Sponsor
Baxter Healthcare Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00161759
Brief Title
Safety and Efficacy Study of Fibrin Sealant (FS 4IU) for Skin Graft Fixation and Wound Healing in Subjects With Burn Wounds
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2006
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Baxter Healthcare Corporation

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Sheet skin grafts affixed with Fibrin Sealant (lyophilized) with 4 IU/mL Thrombin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
65 Years
Eligibility Criteria
Inclusion Criteria: Written informed consent obtained from either the subject or the subject's legally acceptable representative prior to screening activities Male or female age >= 6 and <= 65 years of age Total burn wounds measuring <= 40% TBSA to include a deep partial thickness/full thickness area requiring autologous split thickness sheet skin grafts The selected test area consisting of a contiguous, deep partial thickness/full thickness burn wound between 2% and 8% TBSA, which can be divided into two approximate halves or two bilateral wounds (each measuring between 1% and 4% TBSA) Females of child-bearing potential with a negative urine or serum pregnancy test on admission Able and willing to comply with the procedures required by the protocol Exclusion Criteria: Conductive electrical burns and chemical burns Digits, head, genitalia, palms of hands, soles of feet, and face are excluded as test sites Circumferential burns are excluded as a test area 4th or 5th degree burns Test area with infection as determined clinically by the Investigator prior to surgery Venous or arterial vascular disorder directly affecting a designated test area Known immune deficiency disorder, either congenital or acquired Chronically malnourished as determined clinically by the investigator prior to surgery (Investigators are responsible for determining subjects are chronically malnourished during the screening process. Investigators should take into consideration the following parameters: Medical history and physical appearance, the subject's body mass index, and any significant laboratory findings) Severe respiratory problems or concurrent head trauma at hospital admission Any chronic condition requiring the use of systemic corticosteroids 30 days prior to study entry and anytime during the course of the study Known or newly diagnosed diabetics requiring insulin Any other acute or chronic concurrent medical condition(s) that in the Investigator's opinion are a contraindication to skin grafting and study participation Known or suspected hypersensitivity to bovine protein Concurrent participation in another clinical trial in which an investigational agent is used. (Subjects must not have been enrolled in another clinical trial within 30 days of enrolling in this trial).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David G. Greenhalgh, MD
Organizational Affiliation
University of California Davis Medical Center, Sacramento; Shriners Hospitals for Children, Sacramento, CA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marianne Cinat, MD
Organizational Affiliation
University of California Irvine, Orange, CA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Arnold Luterman, MD
Organizational Affiliation
University of South Alabama Medical Center, Mobile, AL
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nicole Gibran, MD
Organizational Affiliation
University of Washington Burn Center, Seattle, WA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Glenn D. Warden, MD
Organizational Affiliation
Shriners Hospitals for Children, Cincinnati, OH
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Herndon, MD
Organizational Affiliation
Shriners Hospitals for Children, Galveston, TX
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Richard L. Gamelli, MD
Organizational Affiliation
Loyola University Medical Center, Maywood, IL
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sidney F. Miller, MD
Organizational Affiliation
Wright State University, Miami Valley Hospital, Dayton, OH
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Daniel Lozano, MD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Philip E. Fidler, MD
Organizational Affiliation
Bridgeport Hospital, Bridgeport, CT
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kevin Foster, MD
Organizational Affiliation
Maricopa Medical Center, Phoenix, AZ
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
William L. Hickerson, MD
Organizational Affiliation
Joseph M. Still Burn Center at Doctors Hospital, August, GA
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of South Alabama Medical Center
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36617
Country
United States
Facility Name
Maricopa Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85008
Country
United States
Facility Name
UCI Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868-3298
Country
United States
Facility Name
University of California Davis Medical Center; Shriners Hospitals for Children
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
UCSD Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92103-8896
Country
United States
Facility Name
Bridgeport Hospital
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06610
Country
United States
Facility Name
Joseph M. Still Burn Center at Doctors Hospital
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Shriners Hospitals for Children
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Wright State University, Miami Valley Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45409-2722
Country
United States
Facility Name
Shriners Hospitals for Children, Galveston
City
Galveston
State/Province
Texas
ZIP/Postal Code
77550-2725
Country
United States
Facility Name
University of Washington Burn Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

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

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