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

Baxter

Status and phase

Completed

Phase 2

Phase 1

Conditions

Burns

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT00161759

520001

Details and patient eligibility

About

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.

Sex

All

Ages

6 to 65 years old

Volunteers

No Healthy Volunteers

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).