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Clinical Trials/NCT06362226
NCT06362226WithdrawnPhase 1

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

Virginia Commonwealth University0 sites10 target enrollmentStarted: June 5, 2026Last updated:
Conditions
Interventions
Drugs

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Withdrawn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

Experimental

Intervention: Steroid/Antibiotic (Maxitrol) (Drug)

Group A: 5-FU/Kenalog

Experimental

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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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