Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:33 PM
Ignite Modification Date:
2025-12-24 @ 2:33 PM
NCT ID:
NCT00161759
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).
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
65 Years
Study:
NCT00161759
Study Brief:
Protocol Section:
NCT00161759