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 @ 5:48 PM
Ignite Modification Date:
2025-12-24 @ 5:48 PM
NCT ID:
NCT02469168
Eligibility Criteria:
Inclusion Criteria:
* • The subject is a male or female military healthcare beneficiary of any race or ethnicity, aged 18 years or older, who is being treated for a traumatic wound at WRNMMC
* The subject has soft tissue loss resulting from a traumatic mechanism such as an explosive blast (i.e. motar, rocket, IED), high-velocity shells (i.e. missile), an avulsion injury, gunshot wound motor vehicle accident and/or burn secondary to blast
* The subject's full-thickness or deep partial-thickness traumatic wound injury has been treated with INTEGRA™ MBWM as part of their standard of care
* The wound area is at least 200 cm2
* All areas of the study wound area are covered with INTEGRA™ MBWM and has fully engrafted - engrafting defined as the presence of a contiguous vascularized granulation layer indicated by the formation of a viable granulation layer (Note: there may be some areas of incomplete granulation at the INTEGRA™ MBWM application site, these areas will be excluded from the study wound area).
* The subject will comply with protocol requirements
* The subject will provide voluntary written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
Exclusion Criteria:
* Subjects will not be eligible for study participation if they meet any of the following criteria:
* The subject is pregnant and/or lactating (self-reported)
* The subject has evidence of the following lab value results:
1. Hematocrit ≤ 20%
2. INR \> 1.8 second
3. Creatinine (serum) \> 2.0 mg/dL
4. Bilirubin Total (serum) within upper limit of normal (normal range 0.3-1.9 md/dL
5. Liver function test (AST/ALT) greater than 2 times upper limit of normal as defined by the clinical laboratory defined normal ranges
6. Albumin (serum) \< 2.0 g/dL
7. Platelets \< 70 K/µL
* The subject's targeted traumatic wound injury is a craniofacial wound
* The subject's targeted traumatic wound injury is on a weight-bearing surface
* The subject's targeted traumatic wound is a full-thickness burn injury with visible eschar present (Note: Subjects with a traumatic wound of a burn nature secondary to an explosive blast injury resulting in significant soft tissue loss will NOT be excluded)
* The subject has active infection processes, that in the opinion of the investigator may compromise safety or study objectives
* The subject is known to have a pre-existing condition that may interfere with wound healing, e.g. malignancy, diabetes or autoimmune disease, immunocompromised blood borne diseases, has AIDS, is HIV or Hepatitis-A positive, or currently has a severe dermatological disorder (e.g. severe psoriasis, epidermolysis bullosa, pyoderma gangrenosum)
* The subject has other concurrent conditions that in the opinion of the investigator may compromise safety or study objectives
* The subject has a known hypersensitivity to Trypsin and/or Compound Sodium Lactate for Irrigation (Hartmann's) solution
* The subject cannot be compliant with study procedures and that, in the investigator's opinion, would interfere with the study objectives
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02469168
Study Brief:
Protocol Section:
NCT02469168