ST266 Versus Standard Care In Treating Partial Thickness Burns (NCT00886470) | Clinical Trial Compass
TerminatedPhase 1/2
ST266 Versus Standard Care In Treating Partial Thickness Burns
Stopped: This study was terminated early due to slow accrual of patients.
United States16 participantsStarted 2009-06
Plain-language summary
The objective of this protocol is to perform a safety and dose-determination efficacy clinical trial in patients having a degree of partial-thickness burn wounds. The trial will be a prospectively randomized and double-blind trial of ST266 compared with standardized care using 0.9% NaCl (normal saline) solution in the same three treatment regimens.
Who can participate
Age range18 Years – 65 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:
* A signed IRB (Institutional Review Board)- approved Informed Consent Form;
* 18 - 65 years of age;
* Two (2) similar, non-contiguous, partial-thickness burn wounds between 50 cm2 and 250 cm2 in area with blisters removed in a Total Body Surface Area(TBSA) burn of less than or equal to 40% TBSA;
* Burns must be thermal burns of flame or scald etiology;
* Patient must present to the burn center within 8 hours of injury;
* Normal creatinine and bilirubin levels;
* If capable of bearing children, patient must be using a medically accepted means of birth control and have a negative serum pregnancy test;
* Willing to participate in the clinical study and comply with the requirements of the trial.
Exclusion Criteria:
* The two (2) chosen wounds must not be full-thickness (extending through the dermis into the subcutaneous tissue);
* Thermal burn from chemical, electrical or radiation causes;
* Neither the study wound nor the comparator wound can be \< 50 cm2 or \>250 cm2 in size and cannot be on the face or hands;
* Patients with significant pulmonary injury, i.e., smoke inhalation injury requiring ventilator support;
* Patients with diabetes;
* Patients with any immune deficiency including current treatment with corticosteroid medication, chemotherapeutic agents, anti-viral therapy, or concurrent radiation therapy within 30 days of signing the informed consent;
* Abnormal bilirubin, liver function studies (i.e., Alanine transaminase (ALT); Aspartate transam…
What they're measuring
1
The primary endpoint will be the percentage of each wound that has epithelialized during the 21-day treatment period comparing the ST266-treated wound with the saline-treated wound.