Effectiveness of KeraStat Gel for Improved Cosmesis of Partial Thickness Burns (NCT03564795) | Clinical Trial Compass
TerminatedNot Applicable
Effectiveness of KeraStat Gel for Improved Cosmesis of Partial Thickness Burns
Stopped: Low enrollment
United States14 participantsStarted 2018-08-31
Plain-language summary
A randomized, controlled, 30-subject, within-subject trial for examining the effectiveness of KeraStat Gel, as opposed to the institutional standard of care, silver sulfadiazine, in improving cosmesis of the healed wound.
Who can participate
Age range6 Years – 100 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 c…