Clinical trial NCT00161759: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Burns
Lead sponsor: Baxter Healthcare Corporation
Sponsor class: INDUSTRY
First posted: 2005-09-13
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
facility: University of South Alabama Medical Center
state: Alabama
city: Phoenix
country: United States
facility: Maricopa Medical Center
state: Arizona
city: Orange
country: United States
facility: UCI Medical Center
state: California
city: Sacramento
country: United States
facility: University of California Davis Medical Center; Shriners Hospitals for Children
state: California
city: San Diego
country: United States
facility: UCSD Medical Center
state: California
city: Bridgeport
country: United States
facility: Bridgeport Hospital
state: Connecticut
city: Augusta
country: United States
facility: Joseph M. Still Burn Center at Doctors Hospital
state: Georgia
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Cincinnati
country: United States
facility: Shriners Hospitals for Children
state: Ohio
city: Dayton
country: United States
facility: Wright State University, Miami Valley Hospital
state: Ohio
city: Galveston
country: United States
facility: Shriners Hospitals for Children, Galveston
state: Texas
city: Seattle
country: United States
facility: University of Washington Burn Center
state: Washington
Study officials:
affiliation: University of California Davis Medical Center, Sacramento; Shriners Hospitals for Children, Sacramento, CA
name: David G. Greenhalgh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California Irvine, Orange, CA
name: Marianne Cinat, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of South Alabama Medical Center, Mobile, AL
name: Arnold Luterman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington Burn Center, Seattle, WA
name: Nicole Gibran, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shriners Hospitals for Children, Cincinnati, OH
name: Glenn D. Warden, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shriners Hospitals for Children, Galveston, TX
name: David Herndon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Loyola University Medical Center, Maywood, IL
name: Richard L. Gamelli, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wright State University, Miami Valley Hospital, Dayton, OH
name: Sidney F. Miller, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Diego
name: Daniel Lozano, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bridgeport Hospital, Bridgeport, CT
name: Philip E. Fidler, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maricopa Medical Center, Phoenix, AZ
name: Kevin Foster, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Joseph M. Still Burn Center at Doctors Hospital, August, GA
name: William L. Hickerson, MD
role: PRINCIPAL_INVESTIGATOR
References: