The purpose of this study is to evaluate the effectiveness in using subcutaneous 5-FU/Kenalog \& topical Maxitrol Ophthalmic ointment as different therapeutic adjuncts in the prevention of pathologic remodeling after periorbital burns.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Group one subjects receive topical maxitrol ophthalmic ointment twice daily for two weeks
Group two undergoes treatment with a subcutaneous injection of a 5-fluorouracil (5-FU) and Kenalog (triamcinolone) combination (80/20 ratio, 0.3-0.5 mL per session) administered in four sessions, spaced two weeks apart, starting within 48 hours of hospital presentation
Comparison of wound healing time
This outcome is comparing the would healing time between the 2 groups. A shorter would healing time would indicate faster recovery.
Time frame: 12 months
Comparison of infection rate
This outcome is comparing the infection rate during treatment. A lower infection rate may indicate which treatment is superior to the other.
Time frame: 12 months
Comparison of complication rates
Complication rate is assessed through the occurrence of adverse events. A lower complication rate could indicate improved safety and tolerability over one treatment.
Time frame: 12 months
Comparison of pain level
This will be assessed through the standardized pain scale. The scale is from 1-5. 1 being no pain and 5 being excruciating pain. A lower pain score suggests better pain management due to improved healing.
Time frame: 12 months
Comparison of quality of life
The use of the burns outcome questionnaire (BOQ) to assess the participant's quality of life throughout the study. This is a 17 question questionnaire with each question scale being from 0 to 4. 0 being not at all and 4 being very much. The scores are then added up for a total score. The range of total scores is from 0-68. A higher score may indicate improved well-being with a specific treatment.
Time frame: 12 months
Comparison of cosmetic outcome through the Vancouver scar scale (VSS)
Variables in the VSS include pigmentation, vascularity, pliability and height. The range for the total score is 0-13. A lower VSS scores suggest better scar appearance as well as quality.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 12 months
Comparison of cosmetic outcome through the Patient Observer Scar Assessment Scale (POSAS)
Variables in the POSAS include color, thickness, relief, pliability, surface area and overall opinion. The range for the total score is 11-44. Lower POSAS scores indicate improved scar aesthetics.
Time frame: 12 months