Comparison of Collagenase Santyl Ointment With Antibiotic Ointment in the Outpatient Care of Minor Partial Thickness Burns

Study Overview
=================
Brief 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.

Detailed Description
-----------------
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 at 60 & 180 days, up to 6 months. At these visits, the appearance of the scar will be evaluated. This study was originally funded by Smith and Nephew, but Smith and Nephew is no longer providing support for the study.

Official Title
-----------------
Comparison of Collagenase Santyl Ointment With Antibiotic Ointment in the Outpatient Care of Minor Partial Thickness Burns

Conditions
-----------------
Burn, Partial Thickness

Intervention / Treatment
-----------------
* Drug: Collagenase Santyl
* Drug: Bacitracin


Participation Criteria
=================
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 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. 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. The Investigator may declare any subject ineligible for a valid medical reason. 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. Test articles are cost-prohibitive for subjects

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Collagenase Santyl<br>Applied topically (2 mm thickness once daily) | Drug: Collagenase Santyl<br>* A sterile, enzymatic debriding agent which contains 250 collagenase units per gram of white petrolatum, United States Pharmacopeia (USP).<br>|
| Sham Comparator: Bacitracin<br>Applied topically (2 mm thickness) once daily | Drug: Bacitracin<br>* One gram is equal to 500 bacitracin units; one unit of bacitracin is equivalent to 0.026 milligrams.<br>* Other names: Bacitracin Zinc Ointment;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion Healed | Outcome will be reported as percent of wound epithelialization. | 21 Days After Treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scar Appearance using the Vancouver Scar Scale | Scar appearance will be documented using the Vancouver Scar Scale. It assesses 4 variables: vascularity, height/thickness, pliability, and pigmentation. | 90 Days After Treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Santyl, Burn, Partial Thickness Burn, Second Degree Burn, Minor Burn Bacitracin, Scar Appearance