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

Study 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.

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

Conditions
-----------------
Burns

Intervention / Treatment
-----------------
* Drug: Sheet skin grafts affixed with Fibrin Sealant (lyophilized) with 4 IU/mL Thrombin


Participation Criteria
=================
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).

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Sheet skin grafts affixed with Fibrin Sealant (lyophilized) with 4 IU/mL Thrombin|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |