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 @ 1:41 PM
Ignite Modification Date:
2025-12-24 @ 1:41 PM
NCT ID:
NCT03564795
Eligibility Criteria:
Inclusion Criteria:
* Presenting with at least two comparable, discrete, and separate partial thickness thermal burns, as determined by the Investigator, measuring 50 - 1,000 cm2 each
* Study wounds identified are partial thickness depth
* KeraStat Gel and SSD can be applied to randomized study burn wounds as definitive care treatment within 24 hours from time of injury\]
* Overall total body surface area burned \< 20%
Exclusion Criteria:
* Pregnant or nursing
* Prisoner
* Presence of inhalation injury, as determined by the Investigator
* Injury requiring formal intravenous fluid resuscitation
* Concomitant non-thermal traumatic injuries
* Chronic medical conditions including, but not limited to, documented renal impairment (Cr \> 2.5 mg/dL), hepatic impairment (Total bilirubin \> 2.5 mg/dL), thromboembolic disorders, active infection in study wound areas, uncontrolled diabetes (HbA1C \> 7%), HIV infection, history of melanoma or systemic malignancy within the last 10 years
* Receiving corticosteroids, immunosuppressive agents, radiation or chemotherapy, topical growth factors, or any other medication the Investigator feels will affect wound healing
* Not expected to live at least 13 months post-burn
* Received an investigational drug or biologic within 3 months prior to injury
* Previously treated with a skin graft at either of the treatment sites
* Chemical or electrical burn
* Known or documented allergy to sulfonamides
* Proposed study wounds are full thickness
* Any condition the Investigator determines will compromise subject safety or prevent the subject from completing the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
100 Years
Study:
NCT03564795
Study Brief:
Protocol Section:
NCT03564795