Optimizing Ocular Outcomes: A Dual-armed Study for Periorbital Burn Management
NCT ID: NCT06362226
Last Updated: 2026-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1
10 participants
INTERVENTIONAL
2026-02-28
2027-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A: 5-FU/Kenalog
5-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
Group B: Steroid/Antibiotic
Steroid/Antibiotic (Maxitrol)
Group one subjects receive topical maxitrol ophthalmic ointment twice daily for two weeks
Interventions
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Steroid/Antibiotic (Maxitrol)
Group one subjects receive topical maxitrol ophthalmic ointment twice daily for two weeks
5-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
Eligibility Criteria
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Inclusion Criteria
* 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
* Full Thickness and or "Third degree Burns"
* Imprisoned Inmates
* Chemical Burn
* Pregnant women
* Individuals whom are not adults \>18 years of age
18 Years
ALL
No
Sponsors
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Virginia Commonwealth University
OTHER
Responsible Party
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Principal Investigators
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Nikisha Richards, MD, FACS
Role: PRINCIPAL_INVESTIGATOR
Virginia Commonwealth University
Central Contacts
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Other Identifiers
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HM20029491
Identifier Type: -
Identifier Source: org_study_id
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