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 @ 10:35 PM
Ignite Modification Date:
2025-12-24 @ 10:35 PM
NCT ID:
NCT02905435
Eligibility Criteria:
Inclusion Criteria:
* Provides written informed consent (directly or via legal representative) prior to any clinical trial procedures being performed.
* Willing to comply with all study procedures and expects to be available for the duration of the study.
* Male and non-pregnant females ≥ 18 years of age and ≤ 70 years of age.
* Patients with deep partial or full thickness burns (between 10% and 70% inclusive of their TBSA).
Exclusion Criteria:
* Has a known hypersensitivity to polyurethane or silver-containing materials.
* Multiple traumas (significant traumatic injury to a solid organ in addition to skin).
* Presence of a medical condition with a life expectancy of less than 12 months, such as advanced malignancy.
* Presence of a medical condition that might interfere with treatment evaluation; or require a change in therapy including but not limited to, significant immune deficiency, or skin or vascular diseases in the area of the wound.
* Female with known or suspected pregnancy, planned pregnancy, or lactation.
* Has had exposure to any other investigational agent within the last 6 months.
* Has a clinically significant psychiatric illness.
* Has a condition the Investigator believes would interfere with the ability to comply with study instructions, or that might confound the interpretation of the study results or put the subject at undue risk.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02905435
Study Brief:
Protocol Section:
NCT02905435