OPTIMIZING OCULAR OUTCOMES: A DUAL-ARMED STUDY FOR PERIORBITAL BURN MANAGEMENT

Not Applicable

Not yet recruiting

• Conditions: Periorbital Burns
• Interventions: Drug: 5-FU/Kenalog; Drug: Steroid/Antibiotic (Maxitrol)

• Registration Number: NCT06362226
• Lead Sponsor: Virginia Commonwealth University

Brief Summary

The purpose of this study is to evaluate the effectiveness in using subcutaneous 5-FU/Kenalog \& antibiotic ointment with vitamin E as different therapeutic adjuncts in the prevention of pathologic remodeling after periorbital burns.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-08
• Study First Submitted QC: 2024-04-08
• Study First Posted: 2024-04-12
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-26
• Study Start: 2025-05
• Primary Completion: 2026-11
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A: 5-FU/Kenalog	5-FU/Kenalog	-
Group B: Steroid/Antibiotic	Steroid/Antibiotic (Maxitrol)	-

Primary Outcome Measures

Name	Time	Method
Comparison of wound healing time	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 infection rate	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 complication rates	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 Outcome Measures

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