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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This study has been withdrawn prior to enrollment.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
  Purpose

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


Condition Intervention Phase
Burn, Partial Thickness
Drug: Collagenase Santyl
Biological: Bacitracin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Collagenase Santyl® Ointment With Antibiotic Ointment in the Outpatient Care of Minor Partial Thickness Burns

Resource links provided by NLM:


Further study details as provided by Healthpoint:

Primary Outcome Measures:
  • Scar Appearance [ Time Frame: 90 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion healed at two weeks [ Time Frame: 2 weeks after initiation of treatment ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: March 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Collagenase Santyl Drug: Collagenase Santyl
Applied topically (2 mm thickness once daily)
Sham Comparator: Bacitracin Biological: Bacitracin
Applied topically (2 mm thickness) once daily

  Eligibility

Ages Eligible for Study:   2 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01516463

Sponsors and Collaborators
Healthpoint
Investigators
Study Chair: Herbert B Slade, MD Healthpoint
Principal Investigator: Dhaval Bhavsar, MD University of Kansas
  More Information

No publications provided

Responsible Party: Healthpoint
ClinicalTrials.gov Identifier: NCT01516463     History of Changes
Other Study ID Numbers: 017-101-09-031
Study First Received: January 19, 2012
Last Updated: May 15, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Healthpoint:
burn
partial thickness burn
second degree burn
minor burn
scar
Santyl
Bacitracin
outpatient burn center
scar appearance
Kansas City
University of Kansas Medical Center
KUMC

Additional relevant MeSH terms:
Burns
Wounds and Injuries
Bacitracin
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Infective Agents, Local
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 19, 2014