Optimizing Ocular Outcomes: A Dual-armed Study for Periorbital Burn Management
Trial Snapshot
- Phase
- Phase 1
- Status
- Withdrawn
- Enrollment
- 10
- Primary Endpoint
- Comparison of infection rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Group B: Steroid/Antibiotic
Intervention: Steroid/Antibiotic (Maxitrol) (Drug)
Group A: 5-FU/Kenalog
Intervention: 5-FU/Kenalog (Drug)
Outcomes
Primary Outcomes
Comparison of infection rate
Time Frame: 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 wound healing time
Time Frame: 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 complication rates
Time Frame: 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 Outcomes
- Comparison of cosmetic outcome through the Vancouver scar scale (VSS)(12 months)
- Comparison of quality of life(12 months)
- Comparison of cosmetic outcome through the Patient Observer Scar Assessment Scale (POSAS)(12 months)
- Comparison of pain level(12 months)