Optimizing Ocular Outcomes: A Dual-armed Study for Periorbital Burn Management

Virginia Commonwealth University (VCU)

Status and phase: Begins enrollment this month; Phase 1

Conditions: Periorbital Burns

Treatments: Drug: 5-FU/Kenalog; Drug: Steroid/Antibiotic (Maxitrol)

Study type: Interventional

Funder types: Other

Identifiers

NCT06362226

HM20029491

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Group A: 5-FU/Kenalog

Experimental group

Treatment:

Drug: 5-FU/Kenalog

Group B: Steroid/Antibiotic

Experimental group

Treatment:

Drug: Steroid/Antibiotic (Maxitrol)