ST266 Versus Standard Care In Treating Partial Thickness Burns

Stopped early · Phase 1/Phase 2

Conditions studied: Burns

In brief

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.

Key facts

Study ID

NCT00886470

Run by

Noveome Biotherapeutics, formerly Stemnion

People needed

16

Starts

2009-06-01

Expected to finish

2010-03-01

Last updated by the study team

2019-05-15

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 transaminase (AST)> 2.0 times normal);
• Abnormal serum creatinine, receiving hemodialysis or peritoneal dialysis;
• Active cancer or a history of cancer in the 5 years prior to signing the informed consent form (history of basal cell carcinoma is allowed);
• Psychiatric condition or substance abuse which in the Investigator's opinion may pose a threat to patient compliance;
• History of non-compliance with treatment or clinical visit attendance.
• Patients whose burns were previously treated with anything other than ice, cold water or dry dressing.
• Participation in an investigational trial within 30 days of study entry.

Where it is running

• University of South Alabama Dept. of Surgery — Mobile, Alabama, United States
• LAC - USC Medical Center — Los Angeles, California, United States
• Shands Burn Center at the University of Florida — Gainesville, Florida, United States
• University of South Florida / Tampa General Hospital — Tampa, Florida, United States
• Loyola University Medical Center — Maywood, Illinois, United States
• University of Kentucky Chandler Medical Center — Lexington, Kentucky, United States
• Johns Hopkins Burn Center — Baltimore, Maryland, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• University of Missouri Health Care — Columbia, Missouri, United States
• Acute & Critical Care Surgery Barnes Jewish Hospital, Washington University Medical Center — St Louis, Missouri, United States
• University of Rochester — Rochester, New York, United States
• MetroHealth Medical Center — Cleveland, Ohio, United States
• Western Pennsylvania Hospital — Pittsburgh, Pennsylvania, United States
• John S. Dunn Sr. Burn Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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