Using Santyl or Bacitracin on Second Degree Burns

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Healthpoint
ClinicalTrials.gov Identifier:
NCT01516463
First received: January 19, 2012
Last updated: May 15, 2012
Last verified: May 2012

January 19, 2012
May 15, 2012
March 2012
June 2013   (final data collection date for primary outcome measure)
Scar Appearance [ Time Frame: 90 Days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01516463 on ClinicalTrials.gov Archive Site
Proportion healed at two weeks [ Time Frame: 2 weeks after initiation of treatment ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Using Santyl or Bacitracin on Second Degree Burns
Comparison of Collagenase Santyl® Ointment With Antibiotic Ointment in the Outpatient Care of Minor Partial Thickness Burns

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 used to keep the burn covered while it heals. Second degree burns generally leave a scar. Once the burn heals, lotion and an appropriate bandage will be used to try to minimize the appearance of a scar.

The study hypothesis is that burns treated with Santyl will have a better scar appearance than burns treated with bacitracin.

Subjects enrolled in this study will make once a week visits to the University of Kansas Medical Center outpatient burn clinic until the burn heals. The burn will be assessed for healing at these visits. Once healed, visits to the clinic will be every 1-3 months for up to 1 year. At these visits, the appearance of the scar will be evaluated

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Burn, Partial Thickness
  • Drug: Collagenase Santyl
    Applied topically (2 mm thickness once daily)
  • Biological: Bacitracin
    Applied topically (2 mm thickness) once daily
  • Active Comparator: Collagenase Santyl
    Intervention: Drug: Collagenase Santyl
  • Sham Comparator: Bacitracin
    Intervention: Biological: Bacitracin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
December 2013
June 2013   (final data collection date for primary outcome measure)

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 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 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.
  • 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.
Both
2 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01516463
017-101-09-031
No
Healthpoint
Healthpoint
Not Provided
Study Chair: Herbert B Slade, MD Healthpoint
Principal Investigator: Dhaval Bhavsar, MD University of Kansas
Healthpoint
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP