Status:
TERMINATED
ST266 Versus Standard Care In Treating Partial Thickness Burns
Lead Sponsor:
Noveome Biotherapeutics, formerly Stemnion
Conditions:
Burns
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief 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 ran...
Detailed Description
A Phase I/II multi-center clinical trial will be performed in 99 adults with partial-thickness burns. Two similar partial-thickness burn areas in a single patient will be selected. One burn will be ra...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00886470
Start Date
June 1 2009
End Date
March 1 2010
Last Update
May 15 2019
Active Locations (14)
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1
University of South Alabama Dept. of Surgery
Mobile, Alabama, United States, 36617
2
LAC - USC Medical Center
Los Angeles, California, United States, 90033
3
Shands Burn Center at the University of Florida
Gainesville, Florida, United States, 32610
4
University of South Florida / Tampa General Hospital
Tampa, Florida, United States, 33606