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

Burns Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00161759
• Other study ID #: 520001
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 8, 2005
• Last updated: October 19, 2006
• Start date: March 2002
• Est. completion date: January 2004

Study information

• Verified date: October 2006
• Source: Baxter Healthcare Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2004
• Gender: Both
• Age group: 6 Years to 65 Years

Eligibility

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).

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burns

Intervention

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

Locations

Country	Name	City	State
United States	Joseph M. Still Burn Center at Doctors Hospital	Augusta	Georgia
United States	Bridgeport Hospital	Bridgeport	Connecticut
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	Loyola University Medical Center	Maywood	Illinois
United States	University of South Alabama Medical Center	Mobile	Alabama
United States	UCI Medical Center	Orange	California
United States	Maricopa Medical Center	Phoenix	Arizona
United States	University of California Davis Medical Center; Shriners Hospitals for Children	Sacramento	California
United States	UCSD Medical Center	San Diego	California
United States	University of Washington Burn Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Baxter Healthcare Corporation

Country where clinical trial is conducted

United States,