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

Baxter Healthcare Corporation12 sites in 1 country40 target enrollmentMarch 2002

ConditionsBurns

DrugsSheet skin grafts affixed with Fibrin Sealant (lyophilized) with 4 IU/mL Thrombin

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Burns
Sponsor: Baxter Healthcare Corporation
Enrollment: 40
Locations: 12
Status: Completed
Last Updated: 19 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2002

End Date

January 2004

Last Updated

19 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Baxter Healthcare Corporation

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