Comparison of Collagenase With Antibiotic Ointment of Minor Partial Thickness Burns (NCT02673229) | Clinical Trial Compass
TerminatedPhase 4
Comparison of Collagenase With Antibiotic Ointment of Minor Partial Thickness Burns
Stopped: slow enrollment due to cost of medication and conflict of interest enrolling uninsured patients
United States20 participantsStarted 2013-09-30
Plain-language summary
By doing this study, researchers hope to learn if applying Santyl to the burn during the healing process affects the appearance of the resulting scar.
Who can participate
Age range2 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Provide written informed consent, which will consist of reading, signing, and dating the informed consent document after the Investigator, sub-Investigator or other designated study staff member has explained the study procedures, risks, and contact information. For subjects not able to provide informed consent (e.g., minors), a parent or legally authorized representative must provide consent. Assent must be provided as required by the Institutional Review Board (IRB).
✓. Have one or more acute burns which:
✓. are thermal, chemical or electrical in etiology
✓. in aggregate cover \<10% total body surface area (TBSA)
✓. are each equal to or less than 72 hrs old
✓. are each no more than deep partial thickness (2nd degree)
✓. are not visibly infected
✓. Able to take in oral fluids.
Exclusion criteria
✕. Contraindications or hypersensitivity to the use of the test article or their components (e.g., known hypersensitivity to bacitracin).
✕. Embedded foreign bodies in the burn wound which cannot be immediately removed.
✕. The burned tissue includes or is within 1 cm of the eye or genitalia.
✕. Severe perioral burns.
What they're measuring
1
Number of Subjects With at Least 95% Wound Healing
Timeframe: 21 Days After Treatment
2
Number of Subjects With at Least 95% Wound Healing