Periorbital Burns
Conditions
Brief summary
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.
Interventions
DRUGSteroid/Antibiotic (Maxitrol)
Group one subjects receive topical maxitrol ophthalmic ointment twice daily for two weeks
DRUG5-FU/Kenalog
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
Sponsors
Virginia Commonwealth University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female, age greater than or equal to 18 years at the time of signing informed consent * Mechanism of Injury including explosion, thermal, electrical * Clinical diagnosis of periorbital burn wound * Second degree or less periorbital or lid bur * No previous surgical treatment for wound management * Partial Deep thickness Periorbital burn * Partial Thickness Burn * Superficial Burn * Periocular lesions with globe involvement
Exclusion criteria
* Recent surgical intervention for wound * Full Thickness and or "Third degree Burns" * Imprisoned Inmates * Chemical Burn * Pregnant women * Individuals whom are not adults \>18 years of age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of wound healing time | 12 months | This outcome is comparing the would healing time between the 2 groups. A shorter would healing time would indicate faster recovery. |
| Comparison of infection rate | 12 months | This outcome is comparing the infection rate during treatment. A lower infection rate may indicate which treatment is superior to the other. |
| Comparison of complication rates | 12 months | Complication rate is assessed through the occurrence of adverse events. A lower complication rate could indicate improved safety and tolerability over one treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of pain level | 12 months | 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. |
| Comparison of quality of life | 12 months | 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. |
| Comparison of cosmetic outcome through the Vancouver scar scale (VSS) | 12 months | 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. |
| Comparison of cosmetic outcome through the Patient Observer Scar Assessment Scale (POSAS) | 12 months | 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. |
Contacts
PRINCIPAL_INVESTIGATORNikisha Richards, MD, FACS
Virginia Commonwealth University
Outcome results
None listed