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 @ 12:18 PM
Ignite Modification Date:
2025-12-24 @ 12:18 PM
NCT ID:
NCT01587261
Eligibility Criteria:
Inclusion Criteria:
1. Subjects presenting with second and/or third degree burns exceeding 20% total body surface area but not greater than 75% TBSA
2. Age between 18 and 65 years of age
3. Subject has provided full written informed consent prior to the performance of any study-related treatment or procedure
Exclusion Criteria:
1. Subjects presenting more than 6 hours from the estimated time of injury
2. Known inclusion in another interventional clinical trial
3. Subjects with known significant comorbidities (Congestive Heart Failure, Myocardial Infarction within 6 months of admission, Chronic Obstructive Pulmonary Disease, Chronic Kidney Disease or Renal Impairment)
4. Pregnant Subjects
5. Prisoners or Subjects Under Arrest
6. Subjects younger than 18 years of age or older than 65 years of age
7. Subjects with Baux Scores (Age plus % TBSA) greater than 120 (describing a non-survivable injury)
8. Subjects with any known allergy to components included in injectable ascorbic acid
9. Subjects with significant trauma burden (ISS \> 15), including any open fracture, intracranial hemorrhage, or significant intra-abdominal injury.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01587261
Study Brief:
Protocol Section:
NCT01587261