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

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 Overview

• Status: Not yet recruiting
• Conditions: Periorbital Burns
• Intervention / Treatment: Drug: 5-FU/Kenalog; Drug: Steroid/Antibiotic (Maxitrol)

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Nikisha Richards, MD, FACS; Phone Number: 804-828-8643; Email: nikisha.richards@vcuhealth.org
• Study Contact Backup: Name: Terry A Henry Jr., MD; Phone Number: 804-638-1932; Email: terry.henryjr@vcuhealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A: 5-FU/Kenalog	Drug: 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
Experimental: Group B: Steroid/Antibiotic	Drug: Steroid/Antibiotic (Maxitrol); Group one subjects receive topical maxitrol ophthalmic ointment twice daily for two weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of wound healing time	This outcome is comparing the would healing time between the 2 groups. A shorter would healing time would indicate faster recovery.	12 months
Comparison of infection rate	This outcome is comparing the infection rate during treatment. A lower infection rate may indicate which treatment is superior to the other.	12 months
Comparison of complication rates	Complication rate is assessed through the occurrence of adverse events. A lower complication rate could indicate improved safety and tolerability over one treatment.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of pain level	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.	12 months
Comparison of quality of life	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.	12 months
Comparison of cosmetic outcome through the Vancouver scar scale (VSS)	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.	12 months
Comparison of cosmetic outcome through the Patient Observer Scar Assessment Scale (POSAS)	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.	12 months

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Investigators: Principal Investigator: Nikisha Richards, MD, FACS, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Estimated): April 28, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: April 8, 2024
• First Submitted That Met QC Criteria: April 8, 2024
• First Posted (Actual): April 12, 2024

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Burns; Anti-Infective Agents; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Polycyclic Compounds; Fused-Ring Compounds; Anti-Bacterial Agents; Steroids; Maxitrol
• Other Study ID Numbers: HM20029491

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No