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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
A sterile, enzymatic debriding agent which contains 250 collagenase units per gram of white petrolatum, United States Pharmacopeia (USP).
One gram is equal to 500 bacitracin units; one unit of bacitracin is equivalent to 0.026 milligrams.
University of Kansas Medical Center
Kansas City, Kansas, United States
Number of Subjects With at Least 95% Wound Healing
Outcome will be reported as number of subjects with at least 95% wound healing
Time frame: 21 Days After Treatment
Number of Subjects With at Least 95% Wound Healing
Outcome will be reported as number of subjects with at least 95% wound epithelialization
Time frame: 14 days after treatment
Vancouver Scar Scale
Scar appearance will be documented using the Vancouver Scar Scale. It assesses 4 variables: vascularity, height/thickness, pliability, and pigmentation. VSS is derived by adding the score for each variable. Details of VSS is below. The Vancouver Scar Scale Pigmentation (0-2) Normal 0 Hypopigmentation 1 Hyperpigmentation 2 Range of Score: 0-2 with 0 = best outcome, 2 = worst outcome Vascularity (0-3) Normal. 0 Pink 1 Red 2 Purple. 3 Range: 0-3 with 0 = best outcome, 3 = worst outcome Pliability (0-5) Normal 0 Supple 1 Yielding 2 Firm 3 Banding 4 Contracture 5 Range of Score: 0-5, with 0 = best outcome, 5 = worst outcome Height (0-3) Normal (flat) 0 0-2 mm 1 2-5 mm 2 \>5 mm 3 Range of Score 0-3, with 0 = best outcome, 3 = worst outcome Interpretation of Total Score: 0 = best outcome, 13 = worst outcome
Time frame: 90 Days After Treatment
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