Back to resultsUsing Santyl or Bacitracin on Second Degree Burns
Primary Purpose
Burn, Partial Thickness
Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Collagenase Santyl
Bacitracin
Sponsored by
About this trial
This is an interventional treatment trial for Burn, Partial Thickness focused on measuring 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
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Collagenase Santyl
Bacitracin
Arm Description
Outcomes
Primary Outcome Measures
Scar Appearance
Secondary Outcome Measures
Proportion healed at two weeks
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01516463
Brief Title
Using Santyl or Bacitracin on Second Degree Burns
Official Title
Comparison of Collagenase Santyl® Ointment With Antibiotic Ointment in the Outpatient Care of Minor Partial Thickness Burns
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Withdrawn
Study Start Date
March 2012 (undefined)
Primary Completion Date
June 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Healthpoint
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burn, Partial Thickness
Keywords
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Collagenase Santyl
Arm Type
Active Comparator
Arm Title
Bacitracin
Arm Type
Sham Comparator
Intervention Type
Drug
Intervention Name(s)
Collagenase Santyl
Intervention Description
Applied topically (2 mm thickness once daily)
Intervention Type
Biological
Intervention Name(s)
Bacitracin
Intervention Description
Applied topically (2 mm thickness) once daily
Primary Outcome Measure Information:
Title
Scar Appearance
Time Frame
90 Days
Secondary Outcome Measure Information:
Title
Proportion healed at two weeks
Time Frame
2 weeks after initiation of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Herbert B Slade, MD
Organizational Affiliation
Healthpoint
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Dhaval Bhavsar, MD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Using Santyl or Bacitracin on Second Degree Burns
We'll reach out to this number within 24 hrs