Status:
WITHDRAWN
Using Santyl or Bacitracin on Second Degree Burns
Lead Sponsor:
Healthpoint
Conditions:
Burn, Partial Thickness
Eligibility:
All Genders
2-75 years
Phase:
PHASE4
Brief Summary
Subjects who have minor, second degree burns may be enrolled in this study. Subjects will receive either Santyl ointment or bacitracin ointment to apply to the burn until it heals. Bandages will be us...
Eligibility Criteria
Inclusion
- 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 IRB.
- Age 2 - 75 yrs, either sex, any race.
- Have one or more acute burns which:
- • are thermal, chemical or electrical in etiology
- • in aggregate cover \<10% 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.
- Able to comply with the requirement for daily dressing changes, or have a caretaker who is able to comply.
- Willing to make all required study visits.
Exclusion
- 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.
- Airway involvement or aspiration of hot liquids.
- Suspicion of physical abuse.
- Burn wound requires a skin graft.
- Outpatient management of the burn wound is not appropriate.
- Participation in another investigational clinical study within thirty (30) days of the Screening Visit.
- Current or recent (\< 6 months) history of severe, unstable, or uncontrolled neurological, cardiovascular, gastrointestinal, hematological, hepatic, and/or renal disease or evidence of other diseases based upon a review of medical history that, in the opinion of the Investigator, would preclude safe subject participation in the study.
- The Medical Monitor and / or Investigator may declare any subject ineligible for a valid medical reason.
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01516463
Start Date
March 1 2012
End Date
December 1 2013
Last Update
May 16 2012
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